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Intervention Review

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Interventions for treating proximal humeral fractures in adults

  1. Helen HG Handoll1,*,
  2. Benjamin J Ollivere2,
  3. Katie E Rollins3

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 12 DEC 2012

Assessed as up-to-date: 18 APR 2012

DOI: 10.1002/14651858.CD000434.pub3


How to Cite

Handoll HHG, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD000434. DOI: 10.1002/14651858.CD000434.pub3.

Author Information

  1. 1

    Teesside University, Health and Social Care Institute, Middlesbrough, Tees Valley, UK

  2. 2

    Queen's Medical Centre, Department of Trauma and Orthopaedics, Nottingham, UK

  3. 3

    Cambridge University Hospital NHS Foundation Trust, Department of General Surgery, Cambridge, Cambridgeshire, UK

*Helen HG Handoll, Health and Social Care Institute, Teesside University, Middlesbrough, Tees Valley, TS1 3BA, UK. h.handoll@tees.ac.uk. H.Handoll@ed.ac.uk.

Publication History

  1. Publication Status: New search for studies and content updated (conclusions changed)
  2. Published Online: 12 DEC 2012

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This is not the most recent version of the article. View current version (11 NOV 2015)

 
Characteristics of included studies [ordered by study ID]
Agorastides 2007

MethodsRandomised using sequentially numbered sealed envelopes
Assessor blinding: stated for Constant Shoulder Assessment and Oxford scores at 6 and 12 months
Loss to follow-up at 1 year: 10 (all exclusions: 4 wrong prosthesis; 1 pathological fracture; 1 deep infection requiring further procedure; 2 initial greater tuberosity malpositioning; 2 did not attend follow-up visits)


ParticipantsRoyal Liverpool Hospital, Liverpool, UK
Period of study recruitment: October 2002 to October 2003
59 patients with displaced proximal humeral fractures, 3-part or 4-part or articular fractures who were treated with cemented hemiarthroplasty. Isolated non-pathologic fractures < 6 weeks old. Physiologically old patients with poor bone quality. Informed consent.
Exclusion criteria: no extra information
Of 49: 39 female, 10 male; mean age 70 years, range 34 to 85 years


InterventionsIntervention started post surgery (mean 10 days; range 1 to 30 days after injury)
1. Early active assisted mobilisation (after 2 weeks). Arm kept in sling in neutral rotation for 2 weeks; only pendulum and elbow exercises allowed. Between weeks 3 and 6, progressed to active-assisted exercises; from week 7, to active exercises.
2. Late mobilisation (after 6 weeks). Arm kept in sling in neutral rotation for 6 weeks; only elbow exercises allowed. From week 7 to week 12, progressed from pendulum to active-assisted exercises; from week 13, to active exercises.

Both mobilisation protocols were supervised by a team of specialist shoulder physiotherapists


OutcomesLength of follow-up: 1 year; also assessed at 2 and 6 weeks, and 3 and 6 months (coinciding with outpatient visits)
Oxford shoulder score
Constant shoulder score (mobility, strength, pain, activities of daily living)
Range of motion: elevation, external and internal rotation
Complications
Radiological assessment: greater tuberosity migration; superior luxation of prosthesis


NotesThe early mobilisation regimen represented normal practice at the hospital.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo description of method: "Patients were randomly allocated"

Allocation concealment (selection bias)Unclear risk"Randomization took place in the operating theater after the procedure, by use of sequentially numbered, sealed envelopes."

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear risk"At the 6- and 12-month visits, an independent blinded observer completed the Constant Shoulder Assessment and Oxford scores." However, care providers and participants were not blind to allocation and assessment of complications was not blinded either.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo accounting of these, but lack of blinding unlikely to affect reporting of these.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskIncomplete account of participant flow, with exclusion of 10 participants from the analyses.

Incomplete outcome data (attrition bias)
Death, reoperation
High riskNo accounting of these outcomes, but incomplete account of participant flow, with exclusion of 10 participants from the analyses.

Selective reporting (reporting bias)High riskNo protocol available. May have been stopped early, greater tuberosity migration not specifically listed in brief trial entry in the National Research Register (UK).

Balance in baseline characteristics?Unclear riskIncomplete data to back up claims of lack of baseline differences as these given only for 49 (10 excluded) but a 5 year difference in mean age (72 versus 67 years).

Free from performance bias?Unclear riskAlthough 3 upper limb surgeons performing the operations agreed to the same procedures a different uncemented prosthesis was used in 4 subsequently excluded participants.
"Both mobilization protocols were supervised by a team of specialist shoulder physiotherapists."

Bertoft 1984

MethodsUse of permutation table, single-blind, independently administered
Assessor blinded
Loss to follow-up at 1 year: 7/20 (2 excluded)


ParticipantsCentral hospital, Vasteras, Sweden
Period of study recruitment: not stated
20 patients with non or minimally displaced proximal humeral fractures (7 had fracture of the greater tubercle); sling for 10 days.
Exclusion criteria: no information
17 female, 3 male; mean age 64 years, range 50 to 75 years


InterventionsInterventions started 10 to 12 days post injury, after removal of sling.
1. Instructed self exercise: patients instructed to train 5 to 10 minutes, 4 to 5 times daily. They had three training sessions (day 1, weeks 3 & 8 post injury)
2. Conventional physiotherapy: 9 sessions (average 20 to 30 minutes), 1 to 2 times each week, over 10 to 12 weeks. No thermoelectrotherapy.
Assigned: 10/10
Completed ( > 1 year): 7/6


OutcomesLength of follow-up: 1 year; also assessed at 3, 8, 16 & 24 weeks
Range of motion: forward flexion (graph), abduction, internal & external rotation
Functional movements: placing hand on neck, placing hand on back
Pain: when placing hand on neck: combing hair (graph)
Isometric muscle strength: vertical & horizontal pushing
Change of treatment requested


NotesThe 2 excluded participants were in the control group: 1 died and 1 underwent an operation.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskMention of "permutation table" and "randomized controlled" trial

Allocation concealment (selection bias)Low risk"A third person was responsible for the randomization procedure and kept the key to the permutation table"

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear risk"A second physiotherapist examined the patients. She did not know to which group the patient belonged, and the patients were instructed not to tell her." However, there is no guarantee of blinding and, for practical reasons, neither participants nor care provider were blinded

Blinding (performance bias and detection bias)
Death, reoperation
Low riskLack of blinding unlikely to affect assessment of these outcomes

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskParticipant flow provided but large loss to follow-up (7/20 = 35%).

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskParticipant flow provided

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskIncomplete data to back up claims of lack of baseline differences but a 4 year difference in mean age between groups (66 versus 62 years).

Free from performance bias?Low riskNo indication of performance bias.

Fialka 2008

MethodsMethod of randomisation: referral to random list and randomisation timed at surgery
Assessor blinding: no
Loss to follow-up at 1 year: 5/40 (3 deaths, 2 lost to follow-up)


ParticipantsVienna General Hospital, Austria
Period of study recruitment: not stated - lasted 22 months
40 patients with acute 4-part (Neer) proximal humeral fractures (type C: AO/ASIF classification), aged > 50 years, no history of previous problems in either shoulder, informed consent
Exclusion criteria: concomitant vascular or neurological injuries of involved limb; prior operative procedures; neurologic or mental disorders; or drug abuse
30 female, 10 male; mean age 75 years; of 35: range 56 to 88 years


InterventionsSurgery started 7.3 days of injury (0 to 26 days). General anaesthesia used in all cases. Stems were cemented in place and bone grafting was performed using cancellous bone from patient's humeral head.
1. Hemiarthroplasty using EPOCA prosthesis (Argomedical). Fixation of tuberosities using wire cables threaded through a medial and lateral hole in the stem.
2. Hemiarthroplasty using HAS prosthesis (Stryker). Fixation of tuberosities using transosseous braided sutures tied to lateral fin of the stem.
Same general rehabilitation protocol used for both groups: shoulder kept for 2 weeks in immobiliser to prevent active external rotation, passive movement for 15 minutes per day by physiotherapist to avoid contractures and shoulder stiffness. Then, active range of motion increased to horizontal level. Active external rotation initiated after another 2 weeks.
Assigned: ?/?
Completed (at 1 year): 18/17


OutcomesLength of follow-up: 1 year; also assessed at 12 days, 3 & 6 weeks, and 6 months
Functional assessment (individual Constant score, where results were relative to patient's unaffected shoulder)
Range of motion (active forward flexion, abduction, external rotation)
Radiological assessment: resorption of tuberosities, superior migration of prosthesis, anterior subluxations, glenoid erosion, aseptic stem loosening, secondary dislocation of the tuberosities, heterotopic ossification
Deep infection
Periprosthetic fracture
Reoperation & scheduled for reoperation (persistent pain)
Mortality


NotesDifferences between the two prostheses include the type and position of fixation of the tuberosities and the volume of the stem in the metaphyseal area, thus allowing different amounts of additional (autologous) cancellous bone grafting.
The data for heterotopic ossification were contradictory and not used here.
Request for information sent to contact trialist on 19 February 2010.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"The random list was designed to finally produce 2 groups of equal size."

Allocation concealment (selection bias)Unclear risk"Each surgeon was informed at the beginning of the operation as to which implant had randomly been selected."

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes. Standardisation of assessment.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskThe group allocation and baseline data were not provided for 5 participants: 2 lost to follow-up and 3 who had died. Standard deviations not provided.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskGroup allocation not provided for those who had died.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskIncomplete baseline data (5 excluded) to confirm baseline comparability of those in analysis.

Free from performance bias?Low riskNo indication of performance bias: a "general rehabilitation protocol was used for all patients regardless of the type of implant."; each of the 4 participating surgeons was experienced in joint replacement surgery.

Fjalestad 2010

MethodsMethod of randomisation: use of computer software by independent hospital statistician; block size 12; use of numbered opaque sealed envelopes
Assessor blinding: no, but assessment by two independent physiotherapists
Loss to follow-up at 1 year: 2/50 (2 deaths)


ParticipantsOlso University Hospital, Oslo, Norway
Period of study recruitment: May 2003 to May 2008
50 patients with displaced proximal humeral fractures, AO group B2 or C2 (displaced 3-part and 4-part fractures) who were admitted to hospital. Malposition was at least 45° angular deviation in the true frontal (inclination) or transthoracic radiographic projections, regardless of whether the fracture was impacted or not. The greater or lesser tuberosity had to be displaced at least 10 mm. Furthermore, the displacement between the head and metaphyseal/diaphyseal main fragments should not exceed 50% of the diaphyseal diameter. Age 60 years or over. Informed consent. Resident in Oslo.
Exclusion criteria: non-Scandinavian ethnicity, previous history of injury or illness of the injured or contralateral shoulder, injury of the other part of the humerus or the contralateral upper extremity, alcohol- or drug abuse, dementia or neurological disease and severe cardiovascular disease that would contraindicate surgery.
44 female, 6 male; mean age 73 years, range 60 to 88 years


InterventionsInterventions (and randomisation) started after hospital admission. (On admission to the hospital, all patients were immobilized in a modified Velpeau bandage.)
1. Surgery: operation occurred within the first week after admission to hospital. Open reduction and fixation using a minimally open deltopectoral approach with an interlocking plate device (Locking Compression Plate (LCP) of the AO basic type, Synthes, Switzerland) and metal cerclages to secure the tuberosities. Operation was performed under fluoroscopic control. Then immobilisation in a modified Velpeau bandage until self-exercises and instructed physiotherapy was started on the third postoperative day.
2. Conservative treatment: All patients stayed in the hospital for at least 1 day and received the same instructions from the physiotherapist as those allocated to surgery. If the displacement between the head and metaphyseal fragment (main fragments) exceeded 50% of the diaphyseal diameter (subsequent to randomisation), closed reduction was performed in the operating room under general anaesthesia within 48 hours of admission. Immobilisation in a modified Velpeau bandage for 2 weeks before self exercises and instructed physiotherapy started on day 15.
The same self-training programme and instructed physiotherapy programme used for both groups, although the conservative treatment group started 12 days later. Both groups progressed to strengthening exercises at the 6 week time point. Physical therapy and self-exercise were recommended for at least 6 months.
Assigned: 25/25
Completed (at 1 year): 23/25


OutcomesLength of follow up: 2 years; also assessed at 2, 8, 12, 26 and 52 weeks
Constant shoulder score (both shoulders) (3, 6 & 12 months)
ASES (American Shoulder and Elbow Surgeons) questionnaire (sports domains not included - maximum 24 points) (6 & 12 months)
Quality of life score: Harri Sintonen 15D instrument (sexual function domain not included)
Mortality
Fixation failure or redisplacement - subsequent operation
Radiographic outcomes including avascular necrosis (score 2 = no changes; 1 = changes to normal trabecular organisation < 50% of humeral head; 0 = > 50% or partial collapse)
Check for axillary nerve injury
Health economic outcomes, including direct (cost of surgery; cost of hospital stays) and indirect costs (sick leave, family use of time to assist patient)
Length of stay in acute hospital and hospital rehabilitation centre


NotesInformation on the trial received December 2006 from Dr Tore Fjalestad.
Currently only some results for one year follow-up are published. Communication from Dr Tore Fjalestad in April 2010 indicated that the two year follow-up was likely to be finished during 2010. Further information from Dr Tore Fjalestad in April 2012 indicated that the two year follow-up had been submitted to another journal (estimated publication during 2012).

More details on conservative treatment were provided in Fjalestad 2012. Tore Fjalestad also provided in an email (April 2012) the following clarification on the use of closed reduction for 8 conservatively treated participants (this had not been described in the protocol): "The primary X-rays were assessed for classification and decision-making for closed reduction. Those eight patients had a new radiographic examination after allocation to conservative treatment and after the procedure in the operating room, to confirm an acceptable position of the fragments. If not acceptable, the patients had to be treated with ORIF. Surprisingly, only one patient demonstrated unacceptable re-displacement after two weeks, and was analyzed according to intention-to-treat principle in the conservative group at one year."


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The [randomisation] procedure was designed by the statistician at the hospital research centre using the computer software S-PLUS 6.0 for Windows 2002 ... Randomisation was based on equal blocks of length 12, with the exception of the last one, which was interrupted due to 50 patients."

Allocation concealment (selection bias)Low risk"Randomisation was performed by means of consecutively numbered and sealed non-translucent envelopes containing each participant’s allocation to surgery or to conservative treatment." Independent statistician.

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskTwo trained physiotherapists performed the 15D interviews. The physiotherapists were not blinded to group assignment. No provider or participant blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes, but may affect decisions for subsequent surgery.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Low riskParticipant flow diagram provided and intention-to-treat analysis conducted.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskParticipant flow diagram provided and intention-to-treat analysis conducted.

Selective reporting (reporting bias)Unclear riskTrial registered after completion. Small discrepancies in trial inclusion criteria.

Balance in baseline characteristics?Unclear riskStatistically non significant imbalance in gender (5 versus 1 males) and baseline quality of life scores (higher in surgical group).

Free from performance bias?Low riskAll the operations were performed by three surgeons experienced in the procedure performed.

Hodgson 2003

MethodsRandomised using sequentially numbered sealed envelopes
Assessor blinding: yes, on review of patients at home or clinic appointment
Loss to follow-up at 1 year: 4 (1 death); at 2 years: 12 (3 deaths)


ParticipantsRoyal Hallamshire Hospital, Sheffield, UK
Period of study recruitment: November 1998 to April 2000
86 patients, over 40 years old, with minimally displaced 2-part fractures (Neer), including isolated fractures of the greater tuberosity
Exclusion criteria: inability to understand written or verbal information
70 female, 16 male; mean age 70 years


InterventionsIntervention started: at arrival at A&E.
1. Early physiotherapy (within 1 week of the fracture). Most patients were seen by a physiotherapist at clinic the day after their fracture. Patients received a sling for comfort but were instructed to take their arm out of the sling and to perform gradual, assisted movements of the upper limb.
2. Late physiotherapy after 3 weeks of immobilisation in a collar and cuff sling.
Both groups received same rehabilitation programme. First 2 weeks: education and instruction for home exercises; weeks 2 to 4: progression to full passive flexion and light functional exercises; week 4: start of progressive functional exercises. Discharge when both patient and physiotherapist thought independent shoulder function was achieved.


OutcomesLength of follow-up: 2 years, also 8 and 16 weeks and 1 year
Functional assessment (Constant score)
Patients' perceived health status: SF36 (physical function, physical role limitation, pain); Croft shoulder disability questionnaire
Complications
Number of physiotherapy treatment sessions


NotesInformation on this trial received from Mr Hodgson on several occasions. This included draft report of the 2 year follow-up and notice of their plan to extend follow-up to 5 years.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "using sequentially numbered sealed envelopes we randomly allocated patients"

Allocation concealment (selection bias)Low risk"using sequentially numbered sealed envelopes we randomly allocated patients". Also from phone conversation (08/08/2001): "physio opened envelopes when details entered on envelope".

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskBlinded assessor of function but patients and care providers were not blinded.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Low riskA full account of loss to follow-up provided. While 14% at 2 years (12/86), it was under 5% (4/86) at 1 year.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskParticipant flow provided.

Selective reporting (reporting bias)Unclear riskTrial registration was incomplete and differed slightly from final reports.

Balance in baseline characteristics?Unclear riskMore males in the early mobilisation group (11 versus 5).

Free from performance bias?Low riskPerformance bias seemed unlikely.

Hoellen 1997

MethodsRandomisation method unknown
Assessor blinding: not stated
Loss to follow-up at 1 year: 12/30 (3 deaths)


ParticipantsUniversity Clinic Ulm, Germany
Period of study recruitment: 1/12/1994 to 30/06/1996 in Hoellen 1997 report (to 31/08/1998 in Holbein 1999 report)
30* patients with 4-part fractures (Neer). *see Notes.
Exclusion criteria: age < 65 years, > 14 days since fracture, rheumatoid arthritis, previous shoulder injury, terminally ill
24 female, 6 male; mean age 74 years


InterventionsInterventions started within 14 days of fracture.
1. Hemi-arthroplasty (Global prosthesis, DePuy, US) - cemented
2. "Minimal osteosynthesis": tension band wiring - 2 pins + figure of 8 wire
All were given low dose heparin for DVT prophylaxis. The same post-operative treatment was used in both groups. A Glichrist bandage was used for temporary rests. Passive moving exercises started from first postoperative day, with active exercises postponed until after 6 weeks. Referral to rehabilitation clinic for 3 to 4 weeks post discharge.
Assigned: 15/15
Completed (1 year): 9/9


OutcomesLength of follow-up: 1 year
Functional assessment (Constant score)
Mobility (component of Constant score)
Pain (ditto)
Power
Haematoma
Infection
Implant failure
Medical complications
Re-operation
Time on ward
Discharge location
Mortality


NotesThe plan for longer term follow-up was announced in the Hoellen 1997 trial report. Further abstracts and a trial report (Holbein 1999) were identified for the review update (Issue 4, 2003). Holbein 1999 reported on 39 patients (19 versus 20), with 3- and 4-part fractures, 31 (?/?) of whom had been followed up for 1 year and 24 (?/?) for 2 years. Requests (June 2003) for further information, including for denominators, resulted in the discovery that both Dr Holbein and Dr Hoellen were no longer at Ulm.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: prospective randomised trial

Allocation concealment (selection bias)Unclear riskNo details: prospective randomised trial

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskParticipant flow provided but large loss to follow-up (12/30 = 40%); and potential exclusions.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskParticipant flow provided but large loss to follow-up (12/30 = 40%). Serious outcomes though are less likely to be missed.

Selective reporting (reporting bias)High riskInsufficient information to judge this but the pragmatic removal of the power component of the Constant score was post hoc. Also non addressed difference in trial inclusion criteria between the two reports of this trial.

Balance in baseline characteristics?Unclear riskNo information on baseline characteristics of the two treatment groups but inclusion criteria rule out some confounders.

Free from performance bias?Unclear riskSame post-operative treatment but in all there is insufficient information to assess performance bias.

Kristiansen 1988

MethodsMethod of randomisation: unknown, "randomly selected"
Assessor blinding: unlikely
Loss to follow-up at 1 year: 10/31 (4 failed to attend, 2 died, 4 excluded)


ParticipantsRigshospitalet, Copenhagen, Denmark
Period of study recruitment: not stated
30 patients with 31 displaced 2-, 3- and 4-part proximal humeral fractures (Neer).
Exclusion criteria: no information
22 female, 9 male; age range 30 to 91 years


InterventionsInterventions started: not stated.
1. Surgery: Percutaneous reduction (using Steinmann pin under image intensifier control) and external fixation (2 half pins with continuous threads into humeral head and 2 or 3 pins into the humeral shaft, and neutralising bar applied; Steinmann pin removed)
2. Conservative treatment: closed manipulation under general anaesthesia & sling
Assigned: 15/16
Completed (at 1 year): 11/10


OutcomesLength of follow-up: 12 months; also assessed at 3 & 6 months
‘Treatment failure’: poor reduction, pin removal due to loosening
Non-union
Quality of fracture reduction: good, fair, poor
Functional overall score: excellent, satisfactory, unsatisfactory, poor. Neer (without anatomical section)
Complications: avascular humeral head necrosis, deep infection, radiographic pseudarthrosis, refracture
Reoperations
Mortality


NotesIn both groups, functional exercises were started under instruction during the first week.
Excluded participants were: 1 treatment failure (deep infection) in the surgical group; and 2 treatment failures (poor reduction) and 1 refracture in the conservative treatment group.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "randomly selected for treatment"

Allocation concealment (selection bias)Unclear riskNo details: "randomly selected for treatment"

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo blinding reported.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskUnlikely to be affected by lack of blinding

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskExclusion of data for participants with treatment failure and early refracture from 12 month review. Large loss to follow-up (10/31 = 32%).

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskParticipant flow provided.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Low riskNo information on the patient with bilateral fractures but a relatively minor unit of analysis issue.

Free from performance bias?Unclear riskNo information on operator competence/expertise.

Kristiansen 1989

MethodsMethod of randomisation: unknown
Assessor blinding: yes at 2 year follow-up
Loss to follow-up at 2 years: 46/85 (18 deaths, 28 non-attenders)


ParticipantsHvidovre University Hospital, Denmark
Period of study recruitment: 1983
85 patients with proximal humeral fractures; 74% minimally displaced (Neer).
Exclusion criteria: no information
60 female, 25 male; median age 72 years (1 week group), 70 years (3 weeks group)


InterventionsInterventions started immediately or after closed or open manipulation.
1. One week immobilisation in sling and body bandage.
2. Three weeks immobilisation in sling and body bandage.
At the end of immobilisation, instructions were given to perform Codman's pendulum exercises as well as active movements of the elbow and hand.
Assigned: 42/43
Completed (at 2 years): 18/21


OutcomesLength of follow-up: 2 years; also assessed at 1, 3, 6 & 12 months
Overall score (Neer without anatomic section)
Mobility: overall from Neer score (range of motion: flexion, extension, abduction, internal & external rotation)
Function: overall from Neer score (strength, reaching, stability)
Pain: overall from Neer score (none to disabling)
Reflex sympathetic dystrophy


NotesPost immobilisation for both groups: instructions given for Codman’s pendulum exercises as well as active movements of elbow and hand.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "Random allocation to immobilization for 1 to 3 weeks was performed"

Allocation concealment (selection bias)Unclear riskNo details.

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskOnly claimed for outcome assessors at final follow-up: "The 2-year follow-up examination was blind, as the examiners had no knowledge of the period of immobilization."

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo blinding but may not have affected appraisal of mortality (which was not split by treatment group).

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskLarge loss to follow-up (46/85 = 54%). Numbers given for those available at follow-up but incompletely reported data: only medians.

Incomplete outcome data (attrition bias)
Death, reoperation
High riskAlthough numbers given for those available at follow-up, only overall mortality data provided (extracted from graph).

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskAlthough there appeared to be comparability between treatment groups in age and gender, the percentage of minimally displaced fractures (79% versus 70%: 33/42 versus 30/43) differed between the two groups and no information was available on the numbers who had open manipulation (thus entailing surgery).

Free from performance bias?Unclear riskLack of information to judge on performance bias.

Lefevre-Colau 2007

MethodsRandomised using block randomisation (under supervision of a statistician) and telephone to an independent researcher with patient details.
Assessor blinding: yes
Loss to follow-up at 6 months: 10 (all had difficulties in travelling to the hospital for scheduled sessions)


ParticipantsCochlin Hospital, Paris, France
Period of study recruitment: October 2002 to March 2005
74 patients, over 20 years old, with non-operatively treated impacted ("stable") fractures, including minimally displaced (1-part fracture); 2-part (surgical neck or greater tuberosity (1)); and 3-part (surgical neck and greater tuberosity) (Neer). (AO classification also given). Written consent.
Exclusion criteria: pre-existing shoulder pathology, neurological upper limb disorder, indication for shoulder surgery, multiple injuries, high-energy trauma, or difficulties with language or unable to understand rehabilitation programme or other treatment information.
54 female, 20 male; mean age 63 years


InterventionsIntervention started with 72 hours after fracture.
1. Early mobilisation: active rehabilitation begun within 72 hours of fracture: 2 hour sessions supervised by a physiotherapist, 5 times a week. Progressing from physical techniques to manage pain, then passive motion, performed by physiotherapist, in a) abduction, with arm suspension and patient supine (session 1); passive range of motion in forward elevation with the patient in a lateral supine position (session 2), with addition of external rotation with the patient in a seated position at session 8. After 3 weeks, sessions occurred twice a week without arm suspension. Patients wore a sling between sessions for 4 to 6 weeks, depending on the level of pain. After 6 weeks, active range of motion was begun during weekly sessions. Strengthening began at 3 months in twice-monthly sessions. Patients underwent a total of 32 sessions.
2. Usual care, starting with 3 weeks of sling immobilisation. Then 2 hour sessions supervised by a physiotherapist 4 times a week for 4 weeks. Passive mobilisation in all planes without arm suspension was performed by physiotherapist. Patients kept their arm in a sling between sessions for 1 to 3 additional weeks, depending on pain level. Then sessions were scheduled 2 times weekly for 5 weeks. Active range-of-motion exercises began after 6 weeks. After 9 weeks of rehabilitation, sessions occurred twice monthly until 6 months. Each patient underwent a total of 33 sessions.

Patients used oral analgesics to manage pain. After 4 to 6 weeks, patients were advised to perform daily exercises at home. Patients were discharged from the study at 6 months.


OutcomesLength of follow-up: 6 months, also 6 weeks and 3 months
Functional assessment (Constant score: split into subjective and objective components)
Pain
Patient satisfaction
Range of motion: abduction, anterior elevation, lateral rotation
Complications: non-union (0); fracture displacement (0); treatment (injection) for subacromial impingement syndrome
Compliance


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Block randomization involved choosing randomly from among blocks of lengths 4 and 2 to prevent the risk of predictability."

Allocation concealment (selection bias)Low risk"After completion of the trial entry details, an independent researcher responsible for treatment allocation was contacted by telephone."

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear risk"Outcome measures were recorded by two physicians, including one of the authors (F.F.), who were blinded to the treatment assignments." However, care providers and participants were not blinded to allocation.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNot reported.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskData were unavailable from 10 participants (5 in each group) who were lost to follow-up because of difficulties in travelling to the hospital. Their characteristics were reported not to differ from those who attended.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskNot reported.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this; retrospective trial registration.

Balance in baseline characteristics?Low risk

Free from performance bias?Low riskRehabilitation was standardised and "delivered by physiotherapists who were experienced in the field".

Livesley 1992

MethodsMethod of randomisation: unknown, double-blind
Assessor blinding: likely as code only broken at end of trial
Loss to follow-up at 6 months: 3/48


ParticipantsMansfield District General Hospital, Mansfield, UK
Period of study recruitment: November 1988 to May 1990
48 patients with minimally displaced humeral neck fractures (all Neer Group 1); 4 had epiphyseal fractures
Exclusion criteria: able to co-operate with treatment and attend daily therapy for the first 10 working days.
37 female, 11 male; age range 11 to 85 years


InterventionsInterventions started on average 8.6 days since injury, upon referral to physiotherapy department.
1. Pulsed high frequency electromagnetic field (‘Curapulse’), 30 minutes/day for first 10 working days. (Intensity setting 3, pulse repetition frequency 35, maximum pulse power 300 watts.)
2. Dummy apparatus (deactivated machine).
Assigned: 22/26
Completed (at 6 months): 21/24


OutcomesLength of follow-up: 6 months; also assessed at 1 & 2 months
No data provided in report
Range of movement of glenohumeral & scapulothoracic joints
Pain scores, at rest, on movement, analgesia requirement
Muscle wasting and strength
Overall functional assessment score
Subjective opinion of treatment
Overall estimation of treatment (a ‘good result’)
Time to discharge


NotesAll patients received the same standardised physiotherapy regimen.
No data provided in report for comparison between the two interventions.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details provided: "patients were randomized into two groups"

Allocation concealment (selection bias)Low risk"double-blind", and randomisation code was only broken at end of the trial period to permit analyses

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Low risk"double-blind", use of sham control

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo report of these outcomes

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskAlthough loss to follow-up reported, no results were presented for the trial groups.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskNo report of these outcomes

Selective reporting (reporting bias)High riskResults not presented.

Balance in baseline characteristics?Unclear riskBaseline comparability. However, although the article claims "patients ... were referred to the physiotherapy department without delay", the ranges for average time from injury to start treatment were 0 to 17 days (active) and 0 to 27 days (sham).

Free from performance bias?Unclear risk"Standardized physiotherapy regimen". However, although the article claims "patients ... were referred to the physiotherapy department without delay", the ranges for average time from injury to start treatment were 0 to 17 days (active) and 0 to 27 days (sham).

Lundberg 1979

MethodsMethod of randomisation: unknown
Assessor blinding: no, but mention of independent assessors
Loss to follow-up at 3 months: 0/42; not known for final assessment.


ParticipantsGavle, Sweden
Period of study recruitment: not stated
42 patients with undisplaced proximal humeral fractures (all Neer Group 1) fixed with a sling; 13 had avulsion of the greater tuberosity.
Exclusion criteria: no information
37 female, 5 male; mean age 65 years


InterventionsInterventions started 7 days post injury, after removal of sling.
1. Instructed self exercise: patients instructed to train 5 to 10 minutes, 4 to 5 times daily. They had 3 visits (day 1, and 1 & 3 months) to physiotherapist for instructions and checks. At 1 month, patients were told how to extend their exercises to same level as in physiotherapy group.
2. Conventional physiotherapy: 9 visits (average 20 to 30 minutes) between 2 to 3 months; patients encouraged to continue exercise at home. At about 4 weeks, treatment was intensified.
Assigned: 20/22
Completed (at 3 months): 20/22; (at mean 16 months): ?/?


OutcomesLength of follow-up: > 1 year (mean 16 months); also assessed at 1 & 3 months
Range of movement: abduction, shoulder elevation - active & passive
Pain (insignificant, moderate, severe), longstanding
Lifting power of shoulder
Frozen shoulder (secondary)
Neer score (at final evaluation) including failure category
Hand grip strength


NotesNo indication in the report of any loss to follow-up at last follow-up (> 1 year), but cannot be assumed.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details of method: "In all, 42 patients were randomly assigned into two groups."

Allocation concealment (selection bias)Unclear riskNo details of method: "In all, 42 patients were randomly assigned into two groups."

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo blinding, although independent assessment claimed: "Examination was made by physicians and physiotherapists independently at 1 month and 3 months.."

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo reported.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskFull data provided for 1 and 3 months follow-up; but denominators not stated for long-term (mean 16 months) follow-up

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskData not reported for these outcomes

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Low riskNo major imbalances in baseline characteristics

Free from performance bias?Low riskNo indications of performance bias.

Ockert 2010

MethodsMethod of randomisation: used closed envelopes

Assessor blinding: unknown

Loss to follow-up: 10 patients excluded from analysis following randomisation; 6 with polytrauma, 2 with neurologic deficiency and 2 (1 versus 1) who were converted to shoulder arthroplasty intraoperatively. There was no mention of group allocation at randomisation or evaluation in the paper - these (8 versus 2) were notified after contact with the lead trial investigator.


ParticipantsLudwig-Maximilians University, Munich, Germany

Period of study recruitment: August 2006 to July 2008

76 patients, aged over 18 years, with displaced proximal humeral fractures with displacement > 1 cm and angulation of fragments > 45 degrees (Neer criteria).

Exclusion criteria: poly-traumatised patients, neurologic deficit or intra-operative conversion to shoulder arthroplasty. (Paper noted there were no open or pathological fractures.)

Of 66: 48 female, 18 male; mean age 68 years, range 29 to 92 years


Interventions1. Polyaxial angular stable plate fixation (Non-contact bridging – Proximal Humerus (NCB-PH)). Polyaxial plating allows a range of 0 to 15-degree angle off-centre. After insertion, a threaded screw cap locks the axis of the screw.
2. Monoaxial angular stable plate fixation with Proximal Humeral Internal Locking System (PHILOS) Synthes GmbH. Monoaxial locking plate technique is characterized by fixed divergent and convergent screw orientation due to threaded screw holes.

A deltopectoral approach was used for open reduction and internal fixation of all fractures. All patients received prophylactic intravenous antibiotic immediately before surgery. "The postoperative rehabilitation protocol included immediate passive and active-assisted range of motion (ROM) up to 60-degree angle of abduction and elevation without forced external rotation for 6 weeks. Full ROM with active exercises was started 6 weeks after operation.”

Assigned: 39/37

Completed: 29/37


OutcomesLength of follow-up: 6 months (X-rays 1 day, 6 weeks, 3 months and 6 months)

Secondary varus displacement (> 10 degrees)

Delayed union (due to osteonecrosis)
Intra-articular screw cut out

Re-operation: revision surgery and early hardware removal

Infection (none)
Neurovascular injuries (none)


NotesRequest for information sent to Dr Ockert on 2 June 2012. Repeated on 8 June 2012, in email Peter Biberthaler regarding identification and further information on ongoing trial referred to in conference abstract (Biberthaler 2009) - it seems highly likely that the ongoing trial was this trial. However, this was not clear from email from Ben Ockert on 18 June 2012; this also provided details on the method of randomisation, the numbers allocated and analysed in each group


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"consecutive patients ... were prospectively randomized". No description of sequence generation.

Allocation concealment (selection bias)Unclear risk"consecutive patients ... were prospectively randomized". Contact from trialist revealed they "used closed envelope technique for randomization". (Exclusion criteria appeared to be applied post-randomisation.)

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo mention of blinding. Radiographic assessment performed by two trained radiologists twice in separate sessions 8 weeks apart. Consensus decision for osteonecrosis and implant related failure. Criteria for healing stated.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo mention of blinding, but unlikely to affect this.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High risk"Follow-up rate was 71% of all radiographs taken 1 day, 6 weeks, 3 months, and 6 months after surgery."

Numbers of patients allocated or assessed by intervention group provided after personal communication. Post-randomisation exclusions (10/76 = 13%),was imbalanced (8 versus 2) and other loss to follow-up not accounted for.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskAs above. Paper described cases of revision surgery and early removal of metalwork; however, group allocation not given. Information provided subsequently.

Selective reporting (reporting bias)Unclear riskNo protocol available.

Balance in baseline characteristics?Unclear risk"The fracture types were equally distributed in both study groups." However, this applied to 66 participants. Does not state how many patients in each group or compare demographics.

Free from performance bias?Low riskSix experienced surgeons performed the surgery: "In advance of this study, all surgeons were trained in the respective monoaxial and polyaxial locking plate system”.

Same antibiotic regimen and post-op management.

Olerud 2011a

MethodsMethod of randomisation: opaque, sealed envelopes
Assessor blinding: no, but mention of independent surgeon
Loss to follow-up at 24 months: 7/60 (1 excluded themselves; 2 lost; 4 died)


ParticipantsStockholm Söder Hospital, Stockholm, Sweden
Period of study recruitment: April 2003 to March 2008
60 patients with an acute displaced (based on Neer's criteria) 3-part proximal humeral fractures (all had displaced surgical neck fracture, all bar one had a displaced greater tuberosity; the exception had a displaced lesser tuberosity). Age 55 or older with a fracture sustained after a low-energy trauma (e.g. a simple fall). Independent living conditions
Exclusion criteria: patients with a completely displaced shaft in relation to the head fragment or with a valgus impact fracture. Institutionalised, severe cognitive dysfunction (< 3 correct answers on a 10-item Short Portable Mental Status Questionnaire).
48 female, 11 male; mean age 74 years (1 patient excluded themselves), range 56 to 92 years (operations were performed within a mean of 6 (SD 4.1) days after the injury).


InterventionsInterventions (and randomisation) started after hospital admission.
1. Surgery: operation occurred at mean of 6.1 days of injury. Open reduction and fixation using a deltopectoral approach with a PHILOS plate (Synthes, Stockholm, Sweden) and with nonabsorbable sutures used to fix displaced / unstable lesser and/or greater tuberosity fractures. The reduction and position of the implant was checked with the aid of an X-ray image intensifier. (All patients had pre-operative antibiotics.) Post surgery, the arm was placed in a sling and patients were referred to a physiotherapist. The sling was used for 4 weeks; afterwards, the patients were allowed to use it at their own convenience. Pendulum exercises and passive elevation/abduction up to 90 degrees were started from the first postoperative day. After 4 weeks, the patients were allowed a free active range of movement.
2. Conservative treatment: arm immobilisation in a sling for 2 weeks, after which they were allowed to use it at their own convenience. After 2 weeks, the patients were referred to a physiotherapist, and pendulum exercises and passive elevation/abduction up to 90 degrees were started. After 4 weeks, they were allowed a free active range of movement.
Assigned: 30/30
Completed (at 2 years): 27/26


OutcomesLength of follow up: 2 years
Constant shoulder score (both shoulders)
DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire
Quality of life score: EQ-5D
Mortality
Pain
Range of motion: abduction, flexion
Fixation failure, redisplacement, non-union, malunion

Subsequent surgery (reasons including deep infection, etc)
Radiographic outcomes including avascular necrosis and osteoarthritis


NotesTrial run concurrently with Olerud 2011b.

Additional information on randomisation and trial location obtained from Dr Olerud (April 2012). Pain data received May 2012.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"After clearance by an anesthetist, the patients were randomized (independently prepared opaque, sealed envelopes) to open reduction and internal fixation with a locking plate or nonoperative treatment." trial report

"the patients were randomised by numbered sealed opaque envelopes drawn consecutively.

The envelopes were independently prepared and thoroughly mixed. After that the envelopes were numbered by another person. At the time of randomisation the envelopes were drawn in numerical order." personal communication

Allocation concealment (selection bias)Low riskSee above

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo assessor blinding, although "The final 24-month follow-up was performed by an independent orthopaedic surgeon not previously involved in the treatment."

No provider or participant blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes, but may affect decisions for subsequent surgery.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Low risk"In the outcome analyses, all patients remained in their randomization group regardless of secondary procedures according to the intention-to-treat principle." Participant flow provided; no cause for concern.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskAs above.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this. No protocol found.

Balance in baseline characteristics?Low riskNo imbalances: baseline comparability.

Free from performance bias?Low risk"All operations in patients randomized to surgery were performed by 1 of 2 orthopaedic surgeons, both well experienced in shoulder surgery."

While all surgical patients were referred to a physiotherapist after their surgery and conservatively treated patients were referred after 2 weeks, this was unlikely to influence results. Otherwise, similar exercise / rehabilitation schedules.

Olerud 2011b

MethodsMethod of randomisation: opaque, sealed envelopes
Assessor blinding: no, but mention of independent surgeon
Loss to follow-up at 24 months: 6/55 (1 lost; 5 died)


ParticipantsStockholm Söder Hospital, Stockholm, Sweden
Period of study recruitment: April 2003 to March 2008
55 patients with an acute displaced (based on Neer's criteria) 4-part proximal humeral fractures (all had displaced surgical neck, greater and lesser tuberosity fractures). Age 55 or older with a fracture sustained after a low-energy trauma (e.g. a simple fall), no previous shoulder problems. Independent living conditions.
Exclusion criteria: patients with a completely displaced shaft in relation to the head fragment or with a valgus impact fracture. Institutionalised, severe cognitive dysfunction (< 3 correct answers on a 10-item Short Portable Mental Status Questionnaire).
47 female, 8 male; mean age 77 years, range 58 to 92 years


InterventionsInterventions (and randomisation) started after hospital admission.
1. Surgery: operation occurred at mean of 6.0 days of injury. Humeral head replacement using a deltopectoral approach with the Global Fx prosthesis (DePuy, Sollentuna, Sweden); this is a modular prosthesis with a fixed angle and a conventional head - it has 3 fins. Heavy nonabsorbable sutures were tagged on the bone tendon interface of both tuberosities.

Cancellous bone graft from the head fragment was placed between the shaft and the tuberosities. (All patients had pre-operative and 2 doses post-operative antibiotics.) Post surgery, the arm was placed in a sling and patients were referred to a physiotherapist. The sling was used for 6 weeks; afterwards, the patients were allowed to use it at their own convenience. Pendulum exercises and passive elevation/abduction up to 90 degrees were started from the first postoperative day. After 6 weeks, the patients were allowed a free active range of movement. Strengthening exercises were begun after 3 months.
2. Conservative treatment: arm immobilisation in a sling for 2 weeks, after which they were allowed to use it at their own convenience. After 2 weeks, the patients were referred to a physiotherapist, and pendulum exercises and passive elevation/abduction up to 90 degrees were started. After 4 weeks, they were allowed a free active range of movement.
Assigned: 27/28
Completed (at 2 years): 24/25


OutcomesLength of follow up: 2 years
Constant shoulder score (both shoulders)
DASH (Diasabilities of the Arm, Shoulder and Hand) questionnaire
Quality of life score: EQ-5D
Mortality
Pain
Range of motion: abduction, flexion
Fixation failure, redisplacement, non-union, malunion

Subsequent surgery (reasons including non-union, etc)
Radiographic outcomes including avascular necrosis and osteoarthritis


NotesTrial run concurrently with Olerud 2011a.
Additional information on randomisation and trial location obtained from Dr Olerud (April 2012). Pain data received May 2012.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"After clearance by an anesthesiologist, the patients were randomized (opaque sealed envelopes prepared independently) to a primary HA or nonoperative treatment." trial report

"the patients were randomised by numbered sealed opaque envelopes drawn consecutively.

The envelopes were independently prepared and thoroughly mixed. After that the envelopes were numbered by another person. At the time of randomisation the envelopes were drawn in numerical order." personal communication

Allocation concealment (selection bias)Low riskSee above

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo assessor blinding, although "The final 24-month follow-up was performed by an independent orthopaedic surgeon not previously involved in the treatment."

No provider or participant blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskLack of blinding unlikely to affect assessment of these outcomes, but may affect decisions for subsequent surgery.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Low risk"In the outcome analyses, all patients remained in their
randomization group regardless of secondary procedures according to the intention-to-treat principle." Participant flow provided; no cause for concern.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskAs above.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this. No protocol found.

Balance in baseline characteristics?Low riskNo imbalances: baseline comparability.

Free from performance bias?Unclear risk"In patients randomized to surgery, all operations were performed by 1 of 2 orthopedic surgeons, both well experienced in shoulder surgery ..."

While all surgical patients were referred to a physiotherapist after their surgery and conservatively treated patients were referred after 2 weeks, this was unlikely to influence results. As was the differences in timing for free ROM (6 versus 4 weeks). However, it was only reported for the surgical group that strengthening exercises were begun after 3 months.

Revay 1992

MethodsRandomisation from closed envelopes
Assessor blinded
Loss to follow-up at 1 year: 1/48


ParticipantsDanderyd Hospital, Danderyd, Sweden
Period of study recruitment: not stated
48 patients with 2-, 3- or 4-part minimally displaced proximal humeral fractures (< 1 cm or < 45 degrees; Neer Group 1) treated conservatively with sling immobilisation for 1 week.
Exclusion criteria: patients with skin diseases and/or chlorine allergy, non-ambulatory
39 female, 9 male; mean age 66 years


InterventionsInterventions started 5 to 10 days post-injury after removal of sling.
1. Swimming pool training (30 minutes each session, up to 20 sessions maximum) in groups (6 to 8 patients) plus instructions for self training (see below).
2. Instructions for self-training: exercises to be performed at least 4 times a day for 10 to 15 minutes each time, use of hand on injured side for activities of daily living, advice on relaxation and resting positions.
Assigned: 25/23
Completed: ?/?


OutcomesLength of follow-up: 1 year; also assessed at 3 weeks, 2 & 3 months
Pain (analogue scale)
Activities of daily living: subjective assessment of 9 activities each rated on a 5 point scale
Functional scale: 6 point scale
Joint movement (abduction, flexion, internal rotation)


NotesMeans (probably) presented without standard deviations.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "patients were randomized into two groups"

Allocation concealment (selection bias)Unclear riskInsufficient details of safeguards: "randomized and given instructions in a sealed envelope"

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear risk"All patients were examined by a physiotherapist who did not know which group each patient belonged to". However, no participant or care provider blinding nor mention of ways to prevent disclosure to assessor.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNot reported.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskThe treatment group of the participant lost to follow-up was not stated. Standard deviations not provided. Graphs only provided for female participants - denominators not provided for these.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskNot reported. The treatment group of the participant lost to follow-up was not stated.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskBaseline data not provided for gender.

Free from performance bias?Unclear riskUncertainty if any compensatory advice given for the control group.

Rommens 1993

MethodsMethod of randomisation: alternation
Assessor blinding: unlikely
Loss to follow up at 3 weeks: 0/28


ParticipantsLeuven University Hospital, Belgium
Period of study recruitment: 1991
28 patients with acute 2- and 3-part proximal humeral fractures (but most were non or minimally displaced).
Exclusion criteria: those indicated for surgical intervention, age < 15 years, with multiple injuries or other fractures at same site
22 female, 6 male; mean age 69 years, range 25 to 100 years


InterventionsInterventions started immediately.
1. Gilchrist bandage, 2 to 3 weeks. The arm was bandaged with mesh type tubing and held by two slings: one round the shoulder and neck and the other which immobilised the distal part of the upper arm. (Bandage allowed wrist and hand exercises.)
2. Desault bandage, 2 to 3 weeks. Arm was immobilised to the chest using a circular elastic body bandage. (Some had one or more strips of plaster to stop the bandage slipping.)
Assigned: 14/14
Completed (at fracture consolidation): 14/14


OutcomesLength of follow-up: until fracture consolidation; also assessed at 1 & 3 weeks
Functional results: overall result, no data
Pain: patient questionnaire, 0 (none) to 100 (significant) scale
Displacement of fracture
Complication: skin irritation
Removal of bandage
Surgeon assessment of ease of application of bandage
Patient assessment of bandage


NotesTwo fractures in the Gilchrist group required reduction. Seven participants had other fractures: 3 in group 1 (2 rib, 1 vertebra); 4 in group 2 (1 ankle, 1 hip, 1 rib, 1 vertebra).

Trial reports in German; translation obtained.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)High riskQuasi-randomised: alternation

Allocation concealment (selection bias)High riskAlternation

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo mention of blinding

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNot reported

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskWhile all participants were followed up and intention-to-treat analyses seemed to have been done, no data on function were presented nor were the criteria for judging fracture consolidation.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskNot reported

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskSmall discrepancies (e.g. in other injuries or having fracture reduction) can have bigger consequences for small group sizes.

Free from performance bias?Unclear riskDifferences in care programmes cannot be ruled out.

Smejkal 2011

MethodsMethod of randomisation: computer generated block randomisation with sealed envelopes

Assessor blinding: no mention in the paper

Loss to follow-up: 4 lost to follow-up and 2 died of breast cancer during the study period


ParticipantsUniversity Hospital in Hradec Králové, Czech Republic

Period of study recruitment: January 2006 to January 2010

61 patients with AO type A2, A3, B1 and C1 (2 part and 3 part) proximal humerus fractures aged between 18 and 80 years able to give informed consent.

Exclusion criteria: open fracture, associated injury (AIS > 2), open growth plates, or patient's health would limit the extent of surgery.

45 females, 10 males; mean age 61 years, range 21 to 81 years


InterventionsInterventions started 0 to 24 days after injury.
1. Open reduction and internal fixation group: consisted of patients undergoing open reduction with angle-stable osteosynthesis using a PHILOS plate (Synthes, Switzerland).

2. Minimally invasive group: Zifko method of minimally invasive osteosynthesis with intramedullary K-wire insertion (distally inserted) – figure in article shows 8 wires inserted into humeral head along medullary canal.

Assigned: ?/? (total 61)

Completed: 28/27


OutcomesLength of follow-up: mean 2 years

Days to operation

Constant-Murley score (relative to healthy limb)

Time to recover normal upper limb function

Complications
Time to radiographically assessed recovery
Anatomical position

X-ray exposure

Length of operation

Length of hospital stay


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“The patients were randomised to the groups by a computer programme which facilitates the maintenance of homogeneity of the groups compared.”

Web-based translation implied use of random numbers and permuted blocks so as to get similar numbers on each group. Produced independently by a statistical company.

Allocation concealment (selection bias)Low riskThe sealed envelopes were created by a professional statistical company (Pharm test s. r. o., Hradec Králové): in accordance with randomization sheet each envelope their number and sealed inside information," zifko" or "LCP."  The sealed envelopes were opened sequentially.

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNot possible to blind patient / providers. No mention of outcome assessment.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskMay not affect assessment

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskIncomplete data (and group of 6 excluded participants not noted)

Incomplete outcome data (attrition bias)
Death, reoperation
High riskIncomplete data (and group of 2 deaths not stated)

Selective reporting (reporting bias)Unclear riskNo protocol

Balance in baseline characteristics?Unclear riskAside from age – no details or confirmation of this

Free from performance bias?Unclear riskNo details – including of surgeon’s experience

Stableforth 1984

MethodsMethod of randomisation: unknown, "randomly selected"
Assessor blinding: unlikely
Loss to follow-up at 18 months to 12 years: 2/32 (2 deaths)


ParticipantsBristol Royal Infirmary, Bristol, UK
Period of study recruitment: 1970 to 1981
32 patients with displaced 4-part proximal humeral fractures (Neer).
Exclusion criteria: impacted or minimally displaced fractures
25 female, 7 male; mean age 68 years, range 52 to 88 years


InterventionsInterventions started: within 5 days for surgery.
1. Neer prosthesis, uncemented
2. Closed manipulation
All placed in sling, mobilisation of hand encouraged, shoulder flexion rotation exercises after 2 to 3 days. Supervised physiotherapy for 3 to 6 months.
Assigned: 16/16
Completed (at 1 year): 15/15 (but totals given as 16/16 in tables in the trial report)


OutcomesLength of follow-up: stated as 18 months to 12 years; but also assessed regularly up to 6 months
Dependent in activities of daily living
Range of motion (flexion, medial rotation, lateral rotation)
Pain
Muscle strength (flexion, abduction, lateral rotation)
Complications: haematoma, cellulitis, deep sepsis, early shoulder stiffness
Mortality


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "assigned by pre-arranged random selection"

Allocation concealment (selection bias)Unclear riskNo details: "assigned by pre-arranged random selection"

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNot blinded

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo blinding but may not have affected appraisal of mortality

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskLarge loss to follow-up (46/85 = 54%). Numbers given for those available at follow-up but incompletely reported data: only medians.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskSlight discrepancy in trial report that 2 deaths are reported, one in each group, but long term denominators are as at baseline.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this, but the protracted nature of this trial makes selective reporting more likely.

Balance in baseline characteristics?Unclear riskSurgical group on average 4.5 years younger, but uncertainties mainly reflect Inadequate information in terms of other co-morbidities and injuries for this broad category of patients.

Free from performance bias?Unclear riskInadequate information on care programme comparability especially given the protracted nature of the trial recruitment. However, one surgeon operated throughout.

Voigt 2011

MethodsMethod of randomisation: drawing balls from a bag by an independent person

Assessor blinding: assessor blinding

Loss to follow-up at 12 months: 8/56 (did not complete follow-up: 2 deaths, 4 drop-outs, 2 excluded because of early secondary arthroplasty)


ParticipantsFriederikenstift Hospital Hannover, Hannover, Germany

Period of study recruitment: conducted over 18 month period (no dates)

56 patients with isolated Neer type 3- and 4-part proximal humeral fractures, aged > 60 years.

Exclusion criteria: fractures older than 2 weeks, open fractures, pathological fractures, refractures, neurologic disease and patients who would be clearly non-compliant (e.g. alcoholics, patients of no fixed address)

Of 48: 38 female, 10 male; Of 56: mean age 74 years, range 60 to 87 years


InterventionsInterventions started: at surgical fixation (time to surgery from injury not given)

1) Polyaxial locked screws: Humeral Suture Plate (HSP) (Arthrex, Naples, FL) with polyaxially locked screws. Screws were blunt-ended (considered better in the prevention of glenoid erosions in case of screw perforations).

2) Non-polyaxial (monoaxial) implant: Proximal Humerus Internal Locking System (PHILOS) (Synthes, Bettlach, Switzerland) with nonpolyaxially locked screws. (Screws were pointed in the PHILOS plate.)

All surgery performed under general anaesthesia using deltopectoral approach. Tuberosity fragments reduced with fibre wire, different approaches for head fragment depending on whether valgus or varus. Allocated plate positioned anatomically and fixed with a shaft screw.

Patients' shoulders were immobilised in a sling for 2 days. Then, active-assisted motion beyond 90 degrees flexion and abduction were initiated avoiding the provocation of pain. At 7 weeks, free range of motion was allowed.

Assigned: 25/31

Completed: 20/28 (at 12 months)


OutcomesLength of follow-up: 12 months

Simple shoulder test
Disability of the Arm, Shoulder and Hand (DASH) score

Constant score (relative to contralateral limb)
Death
Complications
Re-operation

Range of active shoulder motion (flexion, abduction, internal rotation, external rotation)

Fracture healing - AP and axillary radiographs

Duration of operation

Fluoroscopy time


NotesAdditional information and clarification of 8 participants who did not complete follow-up and gender data for those who completed follow-up obtained from Dr Voigt (May 2012).


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk“The randomization technique was blinded by drawing balls from a bag: one ball for HSP and the other ball for PHILOS by an independent person.”

Allocation concealment (selection bias)Low risk“The randomization technique was blinded by drawing balls from a bag: one ball for HSP and the other ball for PHILOS by an independent person.”

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo mention of blinding of patients or personnel other than assessor blinding: "Follow-up evaluations postoperatively were performed in a standardized fashion by an independent trauma surgeon"

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskUnlikely to influence this.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskAlthough clarification on loss to follow-up (8 patients: 5 versus 3) received from author, the impact on the results for functional outcomes is unclear.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskClarification received from author on the loss to follow-up: 2 were deaths and 2 were replacement arthroplasty.

Selective reporting (reporting bias)Unclear riskNo protocol provided

Balance in baseline characteristics?Unclear riskBalance in 3 versus 4 part fractures, probably age and pre-operative DASH. Incomplete data on gender, 2 versus 6 with diabetes (but no frozen shoulder).

Free from performance bias?Unclear riskNo details of surgeon experience.

Wirbel 1999

MethodsMethod of randomisation: unknown, "random allocation"
Assessor blinding: unlikely
Loss to follow up at 6 months: 13/77; also 14 months (9 to 36 months): 18/77


ParticipantsUniversity Hospital, Homburg/Saar, Germany
Period of study recruitment: January 1995 to March 1998
77 patients with displaced (separation exceeds 1 cm; fragment angulation > 30 degrees, or when tuberosity fragment is separated by > 3 mm) subcapital humeral fractures of type A1, A3, B and C1 (modified AO classification) treated by closed reduction and percutaneous fixation.
Exclusion criteria: Extensive local skin infection. Impacted fractures of type A2 (treated conservatively). Not fit enough to undergo anaesthesia and X-ray of affected shoulder in anterior-posterior plane. Closed reduction not feasible.
54 female, 23 male; mean age 63 years, range 6 to 89 years


InterventionsInterventions started post-operatively after percutaneous fixation (Kirschner wires plus in 38 cases, cannulated screws).
1. 1 week immobilisation in Gilchrist sling
2. 3 weeks immobilisation in Gilchrist sling
Active mobilisation of elbow from first post-operative day. Active and passive physiotherapy of the shoulder (optional continuous passive motion) after removal of sling. Removal of Kirschner wires after 4 to 6 weeks, with post-procedure continuation of active exercises.
Assigned: 38/39
Completed (at 6 months): 32/32


OutcomesLength of follow-up: 9 to 36 (mean 14 months) months (in 59 participants), but also assessed at 1, 3 and 6 months
Neer score
Complications: avascular necrosis, local infection/haematoma, premature removal of Kirschner wires, screw removal due to subacromial impingement


NotesShort report (1997) from conference proceedings gave interim results for 51 patients. Full report and some results provided by Dr Wirbel (February 2003).
Most of the results given in the trial report were either for the whole study population or split by basic AO fracture type.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskNo details: "a random allocation of patients in 2 groups was done"

Allocation concealment (selection bias)Unclear riskNo details: "a random allocation of patients in 2 groups was done"

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo mention of blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNot blinded but less likely that these outcomes would be affected.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
High riskLimited data on function using a non-validated assessment instrument with a moderate loss to follow-up at 6 months (17/77 = 17%).

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskIncomplete data. Although loss to follow-up reported, reoperations were not sufficiently reported by treatment group.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Low riskNo indication of any major baseline imbalance.

Free from performance bias?Low riskNo indication of performance bias from differences in care programmes.

Zhang 2011

MethodsMethod of randomisation: computer generated random numbers

Assessor blinding: likely, "independent" assessor at follow-up

Loss to follow-up: 4 patients within the first year after surgery due to moving out of the area and change of telephone number


ParticipantsThe Third Affiliated Hospital of Whenzou, Whenzou, China

Period of study recruitment: October 2007 to September 2008

72 patients aged over 18 years with an acute closed 2, 3 or 4 part fracture (Neer classification) of the proximal humerus treated with open reduction and internal fixation using a locking plate.

Exclusion criteria: pathological fractures, primary or metastatic tumour and fracture with non-union.

Of 68 followed-up: 46 female, 22 male; mean age 63 years, range 32 to 78 years


InterventionsInterventions started: both at surgery, time from injury not stated

1. ORIF with PHILOS locking plates (Synthes, Switzerland). Standard deltopectoral approach; reduction enabled with a K-wire under fluoroscopy. Locking plate was placed 10 mm posterior to the intertubercular groove and 10 mm distal to the tip of greater tubercle. A cortical screw was inserted initially to fix the distal fragment. Four or five locking screws were used for the fixation of the proximal fragment. All proximal screws were inserted 5 mm below subchondral bone. One or two additional locking screws were inserted obliquely into the medio-inferior region of the humeral head in this group.

The tubercular fragments and rotator cuff tendon were fixed using Ethibond sutures. Autograft bone was used in comminuted fractures where there was a mass defect and for reconstruction of the medial support structures. Fracture reduction and screw length were finally assessed with fluoroscopy.

2. As above without medial support locking screws.

All patients received prophylactic intravenous antibiotics before the procedure. Passive abduction and clock-wise rotation exercises were allowed on the day after surgery. Active rehabilitation was started six weeks postoperatively.

Assigned: 32/40 (total: 72)
Completed (2+ years): 29/39


OutcomesLength of follow-up: average 30.8 months (also 4, 8, 12 weeks, 6, 9 and 12 months and yearly)

Shoulder function (Constant shoulder score)

Union

Complications: osteonecrosis of the humeral head, early failure and loss of fixation
Re-operation


NotesPersonal contact (email 14/05/2012) clarified method of randomisation, group of patients who were lost to follow-up; and complications.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"The patients were randomized into two groups for study according to computer-generated random numbers" (Group sizes, however, were unequal.)

Allocation concealment (selection bias)Unclear riskThere were insufficient safeguards (selection according to odd and even random numbers) to confirm allocation concealment.

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskIt is possible that the participants did not know which group they were in. The difference between the two interventions was not large.
“Complications, shoulder function and radiological measurement were recorded by an independent junior doctor (YJH) who did not participate in the surgery.”

Blinding (performance bias and detection bias)
Death, reoperation
Low riskThese outcomes are fairly robust regarding blinding.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskActive surveillance but missing data for 4 participants lost to follow-up. Personal correspondence gave details on complications.

Incomplete outcome data (attrition bias)
Death, reoperation
Unclear riskMissing data for 4 participants. Personal correspondence provided information on re-operations.

Selective reporting (reporting bias)Unclear riskInsufficient data to judge this. No protocol available.

Balance in baseline characteristics?Unclear riskAlthough the baseline characteristics of 68 participants were comparable, data were missing for 4 participants loss to follow-up.

Free from performance bias?Low risk“Operations were performed by two senior surgeons.” All participants received same rehabilitation.

Zhu 2011

MethodsMethod of randomisation: computer generated random numbers list reviewed by nurse before surgery
Assessor blinding: no, but mention of independent observer
Loss to follow-up at 3 years: 6/57 (5 lost; 1 died)


ParticipantsBeijing Ji Shui Tan Hospital, Beijing, China

Period of study recruitment: November 2004 to December 2006
57 skeletally mature patients with an acute 2-part surgical neck fracture of the proximal humerus (Neer's classification) treated surgically within 21 days of the injury. Patient consent.
Exclusion criteria: open physes, fracture and displacement involving the greater or lesser tuberosity or extension of the fracture line distally beyond the deltoid tubercle, associated musculoskeletal injuries to the same upper extremity, open fracture, and prior surgery on the affected shoulder.
Of 51 followed up: 34 female, 17 male; mean age 53 years


InterventionsInterventions started: surgery on average 9 days after injury (randomisation before surgery).

1. Open reduction with internal fixation using a locking plate: Locking Proximal Humeral Plate (LPHP; Synthes) or the Proximal Humeral Internal Locking System (PHILOS; Synthes). General anaesthesia combined with an interscalene block. Indirect reduction under image intensifier, with reduced fracture temporarily fixed by a Kirschner wire. After placement, position of the locking plate checked with the image intensifier intraoperatively, and the plate was fixed with locking screws. Finally, a thorough fluoroscopic screening was done to ensure that no screw was penetrating the articular surface of the humeral head.

2. Open reduction with internal fixation using a locking nail: the Proximal Humeral Nail (PHN; Synthes). An interscalene brachial plexus block was used. Nail was inserted under image control without reaming after the fracture was fully reduced. After insertion of the spiral blade and the distal locking screws, an end cap was screwed in to lock the spiral blade. The rotator cuff tendon and the deltoid were carefully repaired during wound closure.

The affected extremity was protected by a sling for six weeks postoperatively. Passive range-of-motion exercises, supervised by a physical therapist, were initiated on the first postoperative day. Active and active-assisted exercises began after six weeks, when early callus formation could be seen on radiographs. Strengthening exercises were started three months after the surgery.
Assigned: 29/28
Completed (at 3 years): 26/25


OutcomesLength of follow up: 3 years (also 1 year)
ASES (American Shoulder and Elbow Surgeons) score
Constant shoulder score (both shoulders)
Pain (VAS)
Mortality
Complications (overall, infection (none), heterotopic ossification, screw penetration, pseudothorax)
Re-operation
Range of motion (active flexion, external rotation, internal rotation)
Strength
Duration of surgery
Blood loss and transfusion
Radiographic outcomes including avascular necrosis, union, and degenerative change (osteoarthritis)


Notes


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low risk"Randomization was accomplished with use of a random numbers list generated by software and kept by the operating room nurse."

Allocation concealment (selection bias)Unclear risk"Before the surgery, the circulating nurse reviewed the random-numbers list. Patients who had been assigned an odd number were subsequently treated with a locking nail, and those who had been assigned an even number were managed with a locking plate."

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskNo mention of blinding. However:
"All of the follow-up physical examinations and radiographic evaluations were done by the same independent observer."

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo mention of blinding. Lack of blinding less likely to affect these outcomes.

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Low riskParticipant flow diagram provided; similar and modest losses in each group.

Incomplete outcome data (attrition bias)
Death, reoperation
Low riskDitto - data reported.

Selective reporting (reporting bias)Unclear riskInsufficient information to judge this.

Balance in baseline characteristics?Unclear riskNo indication of any major baseline imbalance in 51 participants followed up at 3 years but no data for 6 participants lost to follow-up.

Free from performance bias?Low riskAll surgical procedures performed by senior surgeon and comparable rehabilitation. Although general anaesthesia used only for the plate group, this was considered unlikely to affect the findings..

Zyto 1997

MethodsMethod of randomisation: sealed envelopes
Independent assessor at final follow-up
Loss to follow-up at 3 years: 14/43 (8 deaths, 2 could not be traced, 1 hemi-prosthesis, 3 exclusions)


ParticipantsHuddinge University Hospital, Stockholm, Sweden
Period of study recruitment: April 1990 to February 1993
43 "elderly" patients with proximal humeral fractures (AO classification system: A 8; B 27; C 8) - see notes.
In trial report:
40 patients with displaced 3- or 4-part fractures (Neer).
Exclusion criteria: pathological fracture, high energy trauma, < 30% contact between humeral head and shaft, other fractures, impaired ability of patient to co-operate, relevant concomitant disease
35 female, 5 male; mean age 74 years


InterventionsInterventions started: surgery within 48 hours.
1. Internal fixation (cerclage wiring (8): or surgical tension band (14)) under general anaesthesia. Antibiotic therapy. Physiotherapy.
2. Conservative treatment: sling for 7 to 10 days. Then physiotherapy.
Assigned: 22/21; (20/20)
Completed (50 months): 15/14


OutcomesLength of follow-up: 3 to 5 years (listed as 50 months in trial report; patient questionnaire, clinical and radiological assessment); also after treatment and at 1 year:
Subjective assessment of function including ability to carry 5 kg, sleep on injured side, comb hair, perform personal hygiene
Constant score: overall shoulder function and components (pain, power, range of motion, activities of daily living)
Complications: deep infection, non-union, pulmonary embolism, avascular necrosis of humeral head
Mortality


NotesBoth groups had the same physiotherapy regimen.

Three patients excluded from 1995 data set (Tornkvist 1995) as, on review by Zyto and a radiologist, the patients did not have 3- or 4-part fractures (personal communication).

Zyto's response to a letter from H. A. Karladani admits that there may have been some inaccuracy in their classification of the fracture patterns but stressed that the Neer classification system was flawed and that other factors such as osteoporotic bone need to be considered too.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear risk"randomised by sealed envelopes"

Allocation concealment (selection bias)Unclear risk"randomised by sealed envelopes" (at time of admission) No indication of safeguards.

Blinding (performance bias and detection bias)
Functional outcomes, pain, clinical outcomes, complications
High riskSome independent assessment by radiographer and potentially by main author but no blinding.

Blinding (performance bias and detection bias)
Death, reoperation
Unclear riskNo blinding but may not have affected appraisal of mortality (which was not split by treatment group).

Incomplete outcome data (attrition bias)
Functional outcomes, pain, clinical outcomes, complications
Unclear riskPost-randomisation exclusions and moderately large loss to follow-up (14/43 = 32%; (11/40 = 28%)).

Incomplete outcome data (attrition bias)
Death, reoperation
High riskOnly whole group data presented for deaths out of 40 participants.

Selective reporting (reporting bias)High riskInsufficient information to judge this but some post-randomisation exclusions and final follow-up performed by first author who does not appear in the earlier reports of the trial.

Balance in baseline characteristics?Low riskNo important imbalances in baseline characteristics.

Free from performance bias?Low riskNo indications of serious performance bias: surgery performed by orthopaedic specialists who were experienced in the surgical technique.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Bing 2002This was a randomised clinical trial (sealed envelopes - computer generated sequence - held in a box), recruitment 03/11/1997 to 14/01/1999, that compared Rush pins fixation with Polaris nail fixation of displaced two part fractures of the proximal humerus. Contact with a Dr Sharma in July 2000 revealed 65 of the 80 patients in the trial had reached 2 year follow-up. Abstract by Bing et al published in 2002 indicated 40 patients of whom 30 had been followed-up for one year. Information gained via Alison Armstrong from Grahame Taylor (one of the authors of the Bing abstract) indicated that there were some concerns about the extent of missing data. Both groups had a high reoperation rate to remove metal ware causing impingement. This trial has been excluded because of insufficient data.

It seems very likely, based on location and study dates, that the trial registration (Der Tavitian 2006) formerly awaiting classification is for this trial.

Bolano 1995No proximal humeral fractures in a randomised trial of humeral shaft fracture treatment.

Brownson 2001This is listed in the National Research Register as a multi-centre randomised trial of the management of displaced surgical neck and displaced shaft fractures of the humerus with the Halder humeral nail. Contact with Mr Brownson revealed this to be part of the trial run from Nottingham (see Wallace 2000) which had been abandoned. Mr Brownson indicated that the very specific inclusion criteria (2-part fractures with over 50% displacement) had reduced the potential sample size; patient consent had also been a problem.

Carbone 2012This is a prospective comparison of MIROS (Minimally Invasive Reduction and Osteosynthesis System®) versus traditional percutaneous pinning, each intervention being carried out at one of two hospitals in the same town in Italy. Not randomised.

Chapman 1997No proximal humeral fractures in a randomised trial of humeral shaft fracture treatment.

Chiu 1997No proximal humeral fractures in a quasi-randomised trial of humeral shaft fracture treatment.

de Boer 2003This is a multi-centre comparative study of locked internal fixators and non-operative treatment. Not randomised.

Dias 2001Trial abandoned. This randomised trial (random number sheets that are remotely administered) compared hemiarthroplasty versus fixation (generally suture reinforced with wires) versus conservative treatment (manipulation, sling for 2 weeks, then mobilisation) for 3- and 4-part fractures of the proximal humerus. Trial started in 2001, with one year follow-up (outcome was assessed by independent physiotherapists). Aimed for 90 to 100 participants, aged > 45 years. Contact with Alison Armstrong revealed that recruitment stalled at 11 patients (16 refusals) in 2008; centre stopped trial when it became a trial site for the ProFHER trial.

Edelson 2008Article mentions an abandoned randomised trial comparing "operative versus conservative care" which was unsuccessful "because patients insisted on proactively choosing rather than being assigned to a treatment group by lot"." No other details given.

Flannery 2006This is listed in the National Research Register as a randomised trial comparing conservative treatment and hemiarthroplasty for four-part fractures of the proximal humerus. Contact with Mr Flannery revealed his centre failed to recruit anyone into the trial. Mr Turner, the lead investigator of the multi-centre trial, involving the South Thames Shoulder and Elbow Group, confirmed that the trial was abandoned due to the inability to recruit patients.

Gradl 2009Prospective study involving 152 patients with unilateral displaced and unstable proximal humeral fractures treated either with an antegrade angular and sliding stable proximal interlocking nail or an angular stable plate. Not a randomised or quasi-randomised trial.

Hems 2000This is listed in the National Research Register as a randomised trial comparing conservative treatment and the Halder humeral nail for displaced fractures of the surgical neck and shaft of the humerus. Contact with Mr Hems revealed this to be part of the trial run from Nottingham (see Wallace 2000). Mr Hems indicated that they had had considerable difficulty in recruiting patients (only those with proximal humeral fractures were eligible in his centre) and had no results.

Liao 2009While the English abstract claims that "70 senile patients" were "randomly divided into three groups to receive different surgical methods" the distribution and characteristics (age and fracture type) of the patients in the three groups indicated serious selection bias and implied this was not a randomised trial. For example: "21 patients in the group A receiving Kirschner tension band or screw internal fixation, 37 patients in group B receiving internal fixation of locking proximal humeral plate, and 12 patients in group C receiving humeral head replacement." There was no reply to request for clarification from the lead author.

Martin 2000Contact with a trialist revealed that due to the discovery of problems with randomisation it was decided not to proceed with publication as the trial results could be compromised.

Mechlenburg 2009This was originally registered as a randomised controlled trial comparing a plate with a hemiarthroplasty. However, it is now registered as a prospective study of fixation with a PHILOS plate. Inger Mechlenburg confirmed that no patients had been included in the trial - the trial was abandoned because no funding was obtained.

Parnes 2005There has been no response from the lead author of this ‘trial’ (last contact attempted 8 June 2012), which appears to have been reported in a conference abstract only. In 2003, 50 patients with 3- and 4-part fractures and fracture dislocations of the proximal humerus were "random selected" for surgery (closed or open reduction and external fixation or hemiarthroplasty) or conservative treatment.  The very limited results are split descriptively according to three groups (2 reflecting the 2 different surgical methods). There is currently insufficient evidence to support this being a randomised trial.

Pullen 2007This is listed in the National Research Register Archive as a randomised trial comparing the T2 proximal humeral nail with the PHILOS plate system in patients with 2- or 3-part proximal humeral fractures. the recruitment target was 100 patients (between 01/09/2005 to 01/09/2007), and follow-up was 16 weeks. We have not located any other report of this study than the details provided in the National Research Register (UK) by, at that time, a Trauma and Orthopaedic Registrar who has now moved to another hospital. There was no response to a request for further information sent 8/6/2012. There is no indication that this study, which may not have started, will ever be reported.

Rodriguez-Merchan 95No proximal humeral fractures in a quasi-randomised trial of humeral shaft fracture treatment.

ShahThis is listed in the National Research Register Archive as a multi-centre randomised trial of the management of four part fractures of proximal humerus that compared hemiarthroplasty versus conservative treatment. The recruitment target was 200 patients, with a one year follow-up using the Constant-Murley shoulder score and Oxford Shoulder score. The listed start and end dates were 01/01/2003 and 01/02/2005. No details were received of the other centres in the very limited further information received from Mr Shah in April 2003. There was no response to a request for further information sent 13/11/06. There is no indication that this study, which may not have started, will ever be reported.

Sinopidis 2010This was registered as a randomised study of reverse shoulder prosthesis and hemiarthroplasty for elderly patients with proximal humeral fractures. However, the principal investigator left the hospital (and country) before it started and a contact at Liverpool (Matthew Smith) confirmed that the study was closed after this.

Wallace 2000This is listed in the National Research Register as a multi-centre randomised trial of the management of displaced surgical neck and displaced shaft fractures of the humerus with the Halder humeral nail. Contact with Prof Wallace's secretary revealed that the study had not gone ahead. The secretary mentioned three other sites (Halifax; Liverpool; and one in Scotland). No reason given. See Brownson 2001.

Wan 2005This is a mixed population trial evaluating additional mobilisation therapy that included other fractures (e.g. clavicular and scapular fractures) as well as proximal humeral fractures. This trial was excluded because separate proximal humeral fracture data were not reported and the contact author is unavailable.

Warnecke 1999A multicentre prospective study but not a randomised trial.

Welsh 2000This is listed in the National Research Register as a randomised comparison of operative and non-operative management of proximal humeral fractures. This trial was abandoned due to poor recruitment, mainly due to lack of patient consent.

Yang 2006Correspondence with the author revealed that this was not a randomised trial. The choice of surgery was dependent on the success of closed reduction.

Zhang 2010While the English abstract claims that "58 patients with 3 parts and 4 parts fractures of proximal humerus were randomly treated with AO locked compressive plates (LCP) or humeral head replacement." the characteristics ( fracture type) of the patients in the two groups indicated serious selection bias and implied this was not a randomised trial. Thus, 25 of 28 patients in the plate group had 3 part fractures (1 with a dislocation) and 3 had 4 part fractures (1 with dislocation) whereas 11 of 30 in the replacement group had 3 part fractures (2 with dislocation), 16 with 4 part fractures (4 with dislocation) and the other three had humeral head split fractures. There was no reply to request for clarification from the lead author.

 
Characteristics of studies awaiting assessment [ordered by study ID]
Battistella 2011

Methods"Randomized clinical study"

Participants54 patients (38 female, 26 male, mean age 61 years) with 2-part surgical neck fractures or 3-part valgus impacted fractures

InterventionsSurgery involving a titanium plate:

1. Minimally invasive fixation based on anterolateral deltoid split approach and percutaneous reduction
2. Open reduction and internal fixation by standard deltopectoral approach

OutcomesConstant score, instrumental activities of daily living, pain (VAS), range of motion, union, complications

NotesRequests for further information sent to Dr Battistella (8 and 14 May 2012) were unsuccessful.

Fjalestad (RCT proposal)

MethodsRandomised trial; 4 centres
"semi-blinded" for the physiotherapist who will examine the patients

Participants110 patients

Interventions1. Reversed shoulder prosthesis

2. ORIF with PHILOS plate

OutcomesPrimary / secondary outcomes will be: Constant score, possibly the Oxford Shoulder score, a QoL score, the “15D”, and a short patient self-evaluation score in addition to the X-ray and CT 3D scans

NotesProposal for this new trial was being finalised in May 2012 (personal communication from Tore Fjalestad)

Luo 2008

MethodsPatients were randomly allocated via a random numbers table.

Participants60 patients (32 females, 28 males; age range: 39 to 62 years) treated operatively for fracture of the surgical neck of the humerus.

Interventions1. Acupuncture (electroacupuncture and infrared radiation) plus passive exercise of the shoulder joint
2. Exercises only: passive exercise of the shoulder joint followed by active exercises

Treatment lasted 1 month.

OutcomesFollow-up: 1 month
shoulder pain score (VAS)
shoulder joint activity

NotesTrial in Chinese with English abstract. Translation of methods section (1.1) confirmed that this was a randomised trial.

 
Characteristics of ongoing studies [ordered by study ID]
Boyer

Trial name or titleRandomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures (HUMERUS)
Official title: Randomised study between intramedullary locking nails and locking plates for treatment of proximal humerus fractures in patients after 40-year-old

MethodsSingle centre, randomised controlled trial. Unblinded.

Participants144 patients, aged between 40 and 85 years, with a type III or IV "cephalotuberosity" proximal humeral fracture (classification of Neer an DUPARC)

Interventions1. Intramedullary nail (Multilock, Synthes)

2. Locking plate (SURFIX, Integra)

OutcomesFollow-up: 1 year
Primary outcome: Constant Score
Secondary outcomes: Quick DASH, complication (malunion, necrosis, infection)

Starting dateStart date: February 2012
Estimated completion date: November 2015

Contact informationDr Patrick Boyer
Group Hospitalier Bichat - Claude Bernard 46, rue Henri-Huchard
Paris
Ile de France
France 75018
patrick.boyer@bch.aphp.fr

Notes

Brorson

Trial name or titleEffect of osteosynthesis, primary hemiarthroplasty, and non-surgical management for displaced four-part fractures of the proximal humerus in elderly: a multi-centre, randomised clinical trial

MethodsMulti-centre, randomised clinical trial (central randomisation unit)

Participants162 patients with displaced 4-part fractures of the proximal humerus

Interventions1. Hemiarthroplasty
2. Fixed-angle plate osteosynthesis
3. Non-surgical treatment

OutcomesFollow-up: 3 years (primary outcome: 1 year)
Primary outcome: Constant Disability Scale
Secondary outcomes: Oxford Shoulder Score, Short Form-36

Starting dateStart date: April 2009
End date: March 2012 (final date for primary outcome measure); * revised date not established (communication June 11 2012)

Contact informationDr Stig Brorson
Department of Orthopaedic Surgery
Herlev University Hospital
Herlev
Denmark
DK-2730
sbrorson@hotmail.com

NotesPublished protocol.

* Correspondence from Stig Brorson (June 11 2012) reveals a slower than anticipated recruitment,

Engelsma

Trial name or titleArthroplasty in three- and four-part proximal humerus fracture: hemi or reverse? Prospective multi-centre randomised clinical trial

MethodsMulti-centre, randomised controlled trial. Unblinded.

Participants52 patients aged over 65 years with displaced 3 or 4 part proximal humerus fractures who are candidates for primary shoulder arthroplasty.

Interventions1. Aequalis fracture prosthesis

2. Aequalis reverse fracture prosthesis

OutcomesFollow-up: 1 year

Primary outcome: Constant Shoulder Score

Secondary outcomes: DASH (Disabilities of the Arm, Shoulder, and Hand) Score, SF-12 questionnaire, Visual Analogue Score of pain

Starting dateStart date: July 2010

Estimated completion date: December 2014

Contact informationYde Engelsma

Medisch Centrum Alkmaar

Wilhelminalaan 12

1815 JD Alkmaar

The Netherlands

y.engelsma@mca.nl

Notes

Guy

Trial name or titleA multicentre prospective randomized control trial on the treatment of three and four part proximal humerus fractures in patients 70 years and older: comparing open reduction and internal fixation with non operative treatment

MethodsRandomised controlled trial: "randomly (like flipping a coin)"

Participants120 patients aged 70 years or over with a 3 or 4 part fracture.

Interventions1. Open reduction and internal fixation
2. Non-operative treatment (reduction and immobilisation)

OutcomesFollow-up: 1 year
Primary outcome: patients' functional shoulder scores as measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Secondary outcomes: functional and mental status instruments (i.e. SF-36/EQ-5D) used to assess the patient's health-related quality of life; re-operation rates; and the time required to return to pre-injury level of independence

Starting dateNovember 2010
Estimated completion date: October 2011

Contact informationContact: Raman Johal (raman.johal@vch.ca)
Principal investigator: Pierre Guy, University of British Columbia, Canada

NotesAs of registration update (17/02/2011) the study was recruiting. Start and end dates amended. 

Helsinki

Trial name or titleEffectiveness and cost-effectiveness of operative and conservative treatment of comminuted fractures of the proximal humerus. A randomised, controlled study.

MethodsRandomised single blind (outcomes assessor)

Participants150 older patients with comminuted, displaced fractures of the proximal humerus.

Inclusion criteria: Age over 65 years; acute trauma with randomisation within 7 days of injury; 3- or 4-part fracture with > 5 mm dislocation of the anatomic neck (AO classification C1-2 for non-luxation fractures; C3 for luxation fractures)

Interventions1. PHILOS locking plate: open reduction of the fracture (and GH joint), internal fixation with the PHILOS locking plate. Tuberculum fragments are sutured to the plate with thick non-absorbable suture.
2. Global FX hemiarthroplasty: replacement of the humeral articular head with hemiprosthesis. Tubercles are sutured to the prosthesis with thick nonabsorbable sutures.
3. Conservative treatment: immobilisation in a supporting brace for 3 weeks, then increasingly active rehabilitation programme supported by a physiotherapist until 12 weeks of the injury.

OutcomesFollow-up: 24 months
Primary outcomes: Pain at rest and activity (Numeric Rating Scale), Constant score
Secondary outcomes: Simple Shoulder test (SST), Disabilities of the Arm, Shoulder and Hand (DASH), quality of life assessment (15D), subjective patient satisfaction, complications and costs.

Starting dateNovember 2010
Final follow-up date: November 2014

Contact informationTuomas Lähdeoja, MD: tuomas.lahdeoja@hus.fi
Mika Paavola, MD: mika.paavola@hus.fi

Helsinki University, Helsinki, Finland

NotesAs of registration update (22/01/2012) the study was recruiting. Start and end dates amended. 

HOMERUS

Trial name or titleHemiarthroplasty versus osteosynthesis in humeral fractures (HOMERUS): A multicentre randomised trial
Official title: Three- and four-part fracture of the proximal humerus in the elderly. Angle stable locking compression plate osteosynthesis versus hemiarthroplasty

MethodsMulti-centre, randomised clinical trial. Single blinded (outcomes assessor).

Participants134 patients aged over 60 years with displaced 3 and 4 part proximal humeral fractures with more than 5 mm of dislocation in one of the fracture planes.

Interventions1. Hemiarthroplasty

2. Angle stable locking compression plate osteosynthesis

OutcomesFollow-up: 2 years

Primary outcome: DASH (Disabilities of the Arm, Shoulder, and Hand) Score

Secondary outcomes: VAS (Visual analogue score) for pain and patient satisfaction, Constant-Murley Score, SF-36, Radiographic evaluation, complications

Starting dateStart date: September 2010

Anticipated completion date: August 2012

Contact informationDr PA Verbeek

Department of Orthopaedic Surgery

University Medical Centre Groningen (UMCG)

Groningen

The Netherlands

paulverbeek@gmail.com

Notes

HURA

Trial name or titleA randomised clinical trial comparing a lateral minimally invasive approach and the traditional anterior approach for plating of proximal humerus fractures

MethodsRandomised, single blind (outcome assessors), clinical trial

Participants90 patients, with humeral surgical neck fracture, Neer II valgus-type, and Neer III.

Interventions1. Lateral minimally invasive approach (plate fixation)
2. Deltopectoral approach (plate fixation)

OutcomesFollow-up: 3, 6, and 12 weeks, and at 6, 12, 18 and 24 months
Primary outcome: Quick DASH
Secondary outcomes: SF-12v2 Questionnaire, Constant Shoulder Score, the Patient Scar Assessment Scale, complication rate

Starting dateStart date: November 2007
End date: January 2012

Contact informationMarie-France Poirer
Hopital Sacré-Coeur
Montreal
Quebec
Canada
H4J1C5
mariefrancepoirier@hotmail.com

NotesEntry for trial (clinicaltrials.gov) on April 10 2012, indicated that "The recruitment status of this study is unknown because the information has not been verified recently"

Loma Linda

Trial name or titleClinical outcome comparison between medial and lateral offset reverse shoulder arthroplasty

MethodsRandomised single blinded trial

Participants40 patients aged between the ages of 50 and 95 years of age who are a candidate for a reverse shoulder arthroplasty. This includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators.

InterventionsTornier Reversed shoulder arthroplasty:
1. Medial offset design
2. Lateral offset design

OutcomesFollow-up: 2 years

Shoulder functional score
Pain scores
Radiological outcomes

Starting dateMay 2010

End date: April 2012

Contact informationWesley Phipatanakul, MD
wphip@hotmail.com

Principal investigator: Montri D Wongworawat, MD,
Loma Linda University Health Department of Orthopaedic Surgery, Loma Linda
Californa 92354
USA

NotesThe future inclusion of this mixed population trial will depend on the numbers of participants with proximal humeral fractures.
As of registration update (21/06/2011) the study was still recruiting  

Pelet

Trial name or titleEffectiveness of intensive rehabilitation on shoulder function after a fracture of the proximal humerus treated by locked plate. A prospective randomized study

MethodsRandomised clinical trial

Participants80 patients aged over 18 years treated by PHILOS locked plate system for unstable closed fracture of the proximal humerus (two-part and three-part fractures according to the Neer classification) within 7 days on injury.

Interventions1. Early and intensive exercise programme
A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation programme without physical therapy. The exercise programme will be provided to the patient. The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0°. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full programme will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist. The patient will complete a daily diary to validate the frequency and intensity of the exercises.

versus

1. Standard rehabilitation programme
The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise programme, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation programme.

OutcomesLength of follow-up: 12 months
Primary outcome: Constant score (adjusted for age) at 6 months. A difference of 10 points is considered significant (standard deviation of 15 points).
Secondary outcomes: Reoperation, redisplacement, Constant score at 12 months, Dash, return to professional activities, pain, range of motion

Starting dateDecember 2009
Final follow-up date: December 2012 (completion: October 2013)

Contact informationHélène Côté, Reg. Nurse: helco3@hotmail.com
Stéphane Pelet, MD, PhD: spelet01@hotmail.com
Hopital de l'Enfant-Jésus, Canada

Notes

ProCon

Trial name or titlePrimary hemiarthroplasty versus conservative treatment for comminuted fractures of the proximal humerus in the elderly (ProCon) - a multicenter randomized trial

MethodsRandomised trial: "variable block randomisation will be accomplished via a trial website"

ParticipantsPatients (65 years or older) with a comminuted proximal humeral fracture.

80 patients (65 years or older) with a comminuted proximal humeral fracture: three-part (Hertel classification type 9, 10, 11), four-part (Hertel type 12), anatomical neck (Hertel type 2), or split-head fractures of the humeral head

Interventions1. Hemiarthroplasty (Affinis® Fracture shoulder endoprosthesis)
2. Conservative treatment (collar and cuff for three weeks)

OutcomesFollow-up: 1, 3 and 6 weeks, and 3, 6, 12 and 24 months

Primary outcome (Constant Score) and secondary outcomes (DASH, pain, radiographic healing, secondary intervention rates, complication rates, mortality rates, SF-36, and EQ-5D)
Costs for (in)formal healthcare consumption

Starting dateStart date: 15 June 2009
Planned end date: 31 December 2013

Contact informationDennis Den Hartog
Department of Surgery-Traumatology
Erasmus MC
University Medical Center
Rotterdam
P.O. Box 2040
3000 CA Rotterdam
The Netherlands
d.denhartog@erasmusmc.nl

NotesPublished protocol

ProFHER

Trial name or titlePragmatic multi-centre randomised trial of surgical versus non-surgical treatment for proximal fracture of the humerus in adults

MethodsMulti-centre randomised controlled trial

Participants250 patients, aged 16 or above, presenting to the participating trauma centre within 3 weeks of their injury with a radiologically confirmed displaced fracture of the proximal humerus involving the surgical neck

Interventions1. Surgery (fixation or joint replacement)
2. Non-surgical management (sling immobilisation)

OutcomesFollow-up: 6, 12 and 24 months
Primary outcome: Oxford Shoulder Score (12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment) assessed at 6, 12 and 24 months via postal questionnaire.
Secondary outcomes: 12-item short form health survey (SF-12) and Euroqol (EQ-5D) for general health status data (at 6, 12 and 24 months); complications, including surgical complications (wound infection, implant failure, shoulder dislocation, septicaemia); early medical complications, i.e. chest infection, confirmed myocardial infarction or stroke, treated deep vein thrombosis and pulmonary embolism; mortality; subsequent referral for operation or substantive treatment; data for economic evaluation: NHS and societal costs

Starting dateStart date: 1/10/2009
End date: 28/02/2014

Contact informationProf Amar Rangan
Consultant Orthopaedic Surgeon
The James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
amar.rangan@stees.nhs.uk

NotesPublished protocol. Extension to recruitment period has resulted in a delay to the completion date (28/02/2014). Recruitment target achieved.

Ring

Trial name or titleEarly vs delayed physical therapy (exercises) for non-operatively-treated proximal humerus fractures: a prospective randomized trial

MethodsRandomised trial

Participants60 patients, aged 18 years or over, with non-operatively treated proximal humeral fractures

Interventions1. Physical therapy started immediately after diagnosis of injury
2. Physical therapy delayed until 3 weeks after diagnosis of injury

OutcomesFollow-up: 6 months
Primary outcome: shoulder flexion
Secondary outcomes: shoulder pain Likert scores; external and internal rotation; abduction; DASH and Constant scores

Starting dateStart date: February 2005
End date: December 2013

Contact informationProf David Ring
Director of Research
Hand Service
Massachusetts General Hospital
Boston
Massachusetts
USA
dring@partners.org

NotesChanges to NCT00438633 on 27 May 2008 seemed to indicate that, despite its official title, this is now a prospective cohort study (accessed: April 10 2012). David Ring confirmed it was still an RCT (April 16 2012).

Stanley

Trial name or titleMinimally invasive versus standard open reduction of proximal humerus fractures
Official title: A prospective randomised controlled trial comparing clinical and radiographic outcomes of the deltopectoral and limited deltoid splitting approaches for fixation of displaced proximal humeral fractures in a skeletally mature population

MethodsSingle-centre, randomised controlled trial. Computer generated random list. Unblinded.

Participants90 patients with displaced proximal humeral fractures

Interventions1. Minimally invasive approach with closed reduction and temporary fixation with k-wires, then the limited deltoid splitting approach (locking plate)
2. Standard open reduction and internal fixation via the deltopectoral approach (locking plate)

OutcomesFollow-up: 1 year

Primary outcome: Constant Shoulder Score and DASH (Disabilities of the Arm, Shoulder, and Hand) Score

Secondary outcomes: radiographic outcomes, complications, union rate

Starting dateAnticipated start date: October 2010 (however, study is not yet recruiting

Contact informationJeremy Stanley

14 Grand Drive

Remuera

Auckland 1050

New Zealand

jellystan@hotmail.com

NotesTrial was not recruiting (nor ethics approval) at time of registration (02/09/2010)

TPHF

Trial name or titleTreatment of Proximal Humeral Fractures (TPHF)
Official title: A national, prospective, randomized, multicenter, controlled head-to-head comparison of conservative, plate fixation and prosthesis in treatment of displaced 2, 3, and 4 part fractures of proximal humerus of 60 years and older patients

MethodsMulti-centre, randomised clinical trial. Single blinded (outcomes assessor)

Participants290 patients aged over 60 years with displaced 2-, 3- and 4-part proximal humeral fractures

Interventions1. PHILOS locking plate

2. Epoca prosthesis
3. Conservative management

OutcomesFollow-up: 2 years

Primary outcome: DASH (Disabilities of the Arm, Shoulder, and Hand) score

Secondary outcome: EQ-5D Questionnaire

Starting dateStart date: January 2011

Estimated completion date: September 2016

Contact informationAntti Launonen

Tampere University Hospital

Tampere

Pirkanmaa

Finland, 33521

antti.launonen@pshp.fi

NotesAs of registration update (01/02/2011), trial was recruiting in Tampere University Hospital, but recruitment had not started in Oulu or Kuopio

 
Comparison 1. Early mobilisation (within or up to 1 week) versus immobilisation for 3 weeks

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Shoulder disability: Croft Shoulder Disability Score1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Disability (1 or more problems) at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Severe disability (5 or more problems) at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Disability (1 or more problems) at 2 years
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.4 Severe disability (5 or more problems) at 2 years
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Croft shoulder disability score: individual problems at 2 years1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Pain on movement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Bathing difficulties
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Change position at night more often
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.4 Disturbed sleep
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.5 No active pastimes or usual physical recreation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.6 Lifting problems
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.7 Help needed
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.8 More accidents (e.g. dropping things)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Number of treatment sessions (until independent function achieved)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 4 SF-36 scores: pain & physical dimensions1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Physical functioning (0-100: excellent) at 16 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 Physical functioning (0-100: excellent) at 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 Role limitation physical (0-100: none) at 16 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.4 Role limitation physical (0-100: none) at 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.5 Pain (0-100: none) at 16 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.6 Pain (0-100: none) at 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Adverse events3Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    5.1 Frozen shoulder
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 Fracture displacement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.3 Non-union
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.4 Reflex sympathetic dystrophy
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.5 Treated (injection) subacromial impingement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Constant shoulder score (ratio of affected/unaffected arm)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 8 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 16 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Constant shoulder score (0 to 100: best)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 6 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 3 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.3 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.4 6 months: subjective assessment (0 to 35: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.5 6 months: objective assessment range of motion and strength (0 to 65: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Changes in pain intensity (mm) from baseline: 100 mm visual analogue scale (positive change = less pain)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 At 6 weeks
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.2 At 3 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.3 At 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Range of motion at 6 months (degrees): difference between two shoulders1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    9.1 Abduction
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    9.2 Anterior elevation
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    9.3 Lateral rotation
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 10 Patient dissatisfied with treatment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Gilchrist bandage versus 'Classic' Desault bandage

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Problems with bandages1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Application of bandage was uncomfortable
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Premature bandage removal
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Fracture displacement by 3 weeks1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Poor or bad rating by patient at fracture consolidation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 3. Instructed self physiotherapy versus conventional physiotherapy

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Pain at one year (scale 0 to 8: maximum pain)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Severe or moderate pain at 3 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Requested change of therapy1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 4 Adverse events (frozen shoulder: 1 v 2; unexplained prolonged pain: 0 v 1)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Neer's rating (0 to 100: best) at mean 16 months (exploratory analysis)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 6 Active gleno-humeral elevation (degrees)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 4. Surgery versus conservative treatment

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Functional scores at 12 months (higher = worse)3153Std. Mean Difference (IV, Fixed, 95% CI)-0.10 [-0.42, 0.22]

    1.1 DASH (0 to 100: worst disability) (reversed)
2105Std. Mean Difference (IV, Fixed, 95% CI)-0.19 [-0.57, 0.19]

    1.2 ASES (0 to 24: best)
148Std. Mean Difference (IV, Fixed, 95% CI)0.10 [-0.46, 0.67]

 2 DASH (0 to 100: worst disability)2Mean Difference (IV, Fixed, 95% CI)Subtotals only

    2.1 at 4 months
2106Mean Difference (IV, Fixed, 95% CI)0.91 [-7.00, 8.83]

    2.2 at 12 months
2105Mean Difference (IV, Fixed, 95% CI)-4.51 [-13.50, 4.48]

    2.3 at 24 months
299Mean Difference (IV, Fixed, 95% CI)-7.43 [-16.26, 1.41]

 3 American Shoulder and Elbow Surgeons score (0 to 24: best)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 at 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 at 12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Activities of daily living1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Unable to manage personal hygiene at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 Unable to comb hair at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.3 Unable to sleep on fractured side at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.4 Unable to carry 5 kg at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.5 Unable to manage personal hygiene at 50 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.6 Unable to comb hair at 50 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.7 Unable to sleep on fractured side at 50 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.8 Unable to carry 5 kg at 50 months
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Quality of life assessment: EuroQol (0: dead to 1: best health)3Mean Difference (IV, Fixed, 95% CI)Subtotals only

    5.1 at 3 to 4 months
3156Mean Difference (IV, Fixed, 95% CI)0.01 [-0.02, 0.05]

    5.2 at 6 months
3156Mean Difference (IV, Fixed, 95% CI)0.04 [-0.01, 0.08]

    5.3 at 12 months
3153Mean Difference (IV, Fixed, 95% CI)0.04 [-0.01, 0.08]

    5.4 at 24 months
2101Mean Difference (IV, Fixed, 95% CI)0.15 [0.05, 0.25]

 6 Quality of life assessment (Fjalestad 2010 data)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 15D at 3 months (0: death; 1: perfect health)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 15D at 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 15D at 12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.4 number of QALYs at 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.5 numbers of QALYs at 1 year (- deaths)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Mortality4196Risk Ratio (M-H, Fixed, 95% CI)1.55 [0.55, 4.36]

 8 Additional surgery (re-operation or secondary surgery)5223Risk Ratio (M-H, Fixed, 95% CI)3.36 [1.33, 8.49]

    8.1 at 6 to 12 months
3113Risk Ratio (M-H, Fixed, 95% CI)1.90 [0.54, 6.73]

    8.2 at 2 years
2110Risk Ratio (M-H, Fixed, 95% CI)5.83 [1.38, 24.70]

 9 Adverse events / complications6Risk Ratio (M-H, Fixed, 95% CI)Subtotals only

    9.1 Infection
6259Risk Ratio (M-H, Fixed, 95% CI)4.13 [0.91, 18.87]

    9.2 Nerve injury / palsy
3146Risk Ratio (M-H, Fixed, 95% CI)0.74 [0.20, 2.76]

    9.3 Non union
5223Risk Ratio (M-H, Fixed, 95% CI)0.48 [0.16, 1.40]

    9.4 Avascular necrosis
5213Risk Ratio (M-H, Fixed, 95% CI)0.65 [0.37, 1.16]

    9.5 Post-traumatic osteoarthritis (signs of)
3133Risk Ratio (M-H, Fixed, 95% CI)0.56 [0.21, 1.51]

    9.6 Screw penetration into joint
3160Risk Ratio (M-H, Fixed, 95% CI)11.49 [2.25, 58.76]

    9.7 Impingement
158Risk Ratio (M-H, Fixed, 95% CI)2.0 [0.19, 20.86]

    9.8 Redisplacement resulting in an operation
281Risk Ratio (M-H, Fixed, 95% CI)0.26 [0.03, 2.22]

    9.9 Secondary dislocation or resorption of the greater tuberosity
151Risk Ratio (M-H, Fixed, 95% CI)15.18 [0.92, 249.78]

    9.10 Tuberosity displacement at 50 months
129Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.01, 2.71]

    9.11 Wire penetration at 1 year
138Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 69.31]

    9.12 Fixation failure resulting in an operation
150Risk Ratio (M-H, Fixed, 95% CI)3.0 [0.13, 70.30]

    9.13 Refracture
122Risk Ratio (M-H, Fixed, 95% CI)1.0 [0.07, 14.05]

 10 Constant scores (overall: 0 to 100: best score)4Mean Difference (IV, Fixed, 95% CI)Subtotals only

    10.1 at 4 months
2107Mean Difference (IV, Fixed, 95% CI)-1.33 [-6.80, 4.14]

    10.2 at 12 months
3152Mean Difference (IV, Fixed, 95% CI)2.36 [-3.52, 8.24]

    10.3 at 24 months
2101Mean Difference (IV, Fixed, 95% CI)0.48 [-7.26, 8.22]

    10.4 at 50 months
129Mean Difference (IV, Fixed, 95% CI)-5.0 [-17.52, 7.52]

 11 Constant scores (difference between injured and uninjured shoulder): Normal = 0.1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    11.1 at 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    11.2 at 12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 12 Poor or unsatisfactory function at 1 year (Neer rating)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 13 Dependent in activities of daily living (or dead) at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 14 Pain at 2 years: VAS (0 to 100: worst pain)2101Mean Difference (IV, Fixed, 95% CI)-6.38 [-14.18, 1.41]

 15 Constant score at 50 months: overall and components1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    15.1 Overall score (0-100: best score)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.2 Pain (maximum score 15)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.3 Range of motion (maximum score 40)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.4 Power (maximum score 25)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    15.5 Activities of daily living (maximum score 20)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 16 Constant (often severe) pain at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 17 Failure to recover 75% muscle power relative to other arm (survivors) at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    17.1 Flexion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    17.2 Abduction
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    17.3 Lateral rotation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 18 Range of movement impairments in survivors at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    18.1 Flexion < 45 degrees
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    18.2 Unable to place thumb on mid spine (T12)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    18.3 Lateral rotation < 5 degrees
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 19 Costs at 1 year (Euros in 2005)Other dataNo numeric data

 20 Total costs including indirect costs (Euros) at 1 year1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Analysis 4.19 Comparison 4 Surgery versus conservative treatment, Outcome 19 Costs at 1 year (Euros in 2005).
Costs at 1 year (Euros in 2005)

StudyMeasureSurgeryConservative treatmentDifference (conclusion)

Fjalestad 2010Total health-care costsmean = 10,367mean = 10,946Abstract: "the mean difference in total health-care costs was 597 Euros in favour of surgery (95% CI = -5291, 3777)". No significant difference.

Fjalestad 2010Health-care + indirect costsmean = 23,953mean = 21,878Reformatted text: "Including indirect costs... the difference [was] 2,075 (95% CI = -15,949 to 20,100)". No significant difference, but favours the conservative group.

 
Comparison 5. Locking plate versus locking intramedullary nail

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 American Shoulder and Elbow Surgeons (ASES) score (0 to 100: best)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 At 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 At 3 years
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Death, re-operation and adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Death
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Any complication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Screw penetration into humeral head (all had re-operation)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.4 Heterotopic ossification
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.5 Infection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.6 Osteonecrosis
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.7 Degenerative change of glenohumeral joint
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.8 Secondary varus collapse
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.9 Non-union
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Pain (VAS: 0 to 10: worst)Other dataNo numeric data

 4 Constant score (0 to 100: best)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 At 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 At 3 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Active range of motion (at 3 years)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    5.1 Forward elevation (degrees)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    5.2 External rotation
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 6 Range of movement: internal rotation (level on spine)Other dataNo numeric data

 7 Strength of suprapinatus (relative to opposite side) % - at 3 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 At 1 year
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 At 3 years
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Operation times and blood loss1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 Duration of surgery (minutes)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.2 Blood loss (ml)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 9 Intra-operative complication1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    9.1 Pneumothorax
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    9.2 Blood transfusion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Analysis 5.3 Comparison 5 Locking plate versus locking intramedullary nail, Outcome 3 Pain (VAS: 0 to 10: worst).
Pain (VAS: 0 to 10: worst)

StudyMeasureLocking plateLocking nailReported significance

Zhu 2011Pain at 1 yearmedian = 0.5

interquartile range: 1.8

n = 29
median = 1.0

interquartile range = 1.0
n = 26
P = 0.042

Zhu 2011Pain at 3 yearsmedian = 0

interquartile range = 0.8
n = 26
median = 0

interquartile range = 1.0
n = 25
P = 0.642

 
Analysis 5.6 Comparison 5 Locking plate versus locking intramedullary nail, Outcome 6 Range of movement: internal rotation (level on spine).
Range of movement: internal rotation (level on spine)

StudyMeasureLocking plateLocking nailReported significance

Zhu 2011At 1 yearmean location = T8

range = T4 to L2
n = 29
mean location = T9

range = T2 to buttock
n = 26
P = 0.443

Zhu 2011At 3 yearsmean location = T8

range = T2 to buttock
n = 26
mean location = T8

range = T2 to buttock
n = 25
P = 0.636

 
Comparison 6. Locking plate versus intramedullary nails (Zifko method)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Complications and [slight] malunion1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Any complication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Malunion (usually slight)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Constant score (% of healthy limb) at mean 2 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Time to union and time to recover upper limb function (weeks)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Time to radiographic union
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 Time to recover normal upper limb function
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Operation and fluoroscopic times1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Duration of operation (minutes)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 X-ray exposure (minutes)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 5 Length of hospital stay (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 7. Hemi-arthroplasty versus tension band wiring (4 part fractures)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Re-operation at 1 year1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Implant removal at 1 year1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Pain at 1 year1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 8. Polyaxial versus monoaxial screw insertion in plate fixation

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 DASH score at 12 months (0 to 100: greatest disability)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Simple shoulder test (0 to 12: best outcome)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 At 3 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 At 6 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 At 12 months
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Re-operation2122Risk Ratio (M-H, Fixed, 95% CI)1.43 [0.56, 3.67]

    3.1 By 6 months
166Risk Ratio (M-H, Fixed, 95% CI)0.85 [0.15, 4.76]

    3.2 By 1 year
156Risk Ratio (M-H, Fixed, 95% CI)1.86 [0.59, 5.88]

 4 Dead at 1 year1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 5 Constant score at 12 months (% of contralateral limb)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 6 Complications (radiological assessment)2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    6.1 Any complication
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 Primary implant malposition
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 Secondary loss of reduction and screw perforation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.4 Non-union / delayed union due to osteonecrosis (6 months)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.5 Avascular necrosis at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.6 Varus deformity (> 10 / ≥20 degrees)
2Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.7 Greater tuberosity displacement
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.8 Screw cut-out (intra-articular)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 7 Range of motion (degrees) at 12 months1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 Flexion
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 Abduction
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.3 External rotation
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.4 Internal rotation
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Operation and fluoroscopic times1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    8.1 Duration of operation (minutes)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    8.2 Fluoroscopic time (minutes)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Comparison 9. Medial support screws versus control for locking plate fixation

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Early loss of fixation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Re-operation for early failure
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.3 Osteonecrosis (asymptomatic)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Constant score (0 to 100: best) at 2.5 years1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 
Comparison 10. Hemiarthoplasty: EPOCA prosthesis versus HAS prosthesis

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Adverse events1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Deep infection
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    1.2 Persistent pain - scheduled for reoperation
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 2 Radiological assessment findings1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Resorption of tuberosities
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Secondary dislocation of tuberosities
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Superior migration of prosthesis
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.4 Anterior subluxations
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.5 Glenoid erosion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.6 Aseptic loosening of stem
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Range of motion results at one year (degrees)Other dataNo numeric data

 
Analysis 10.3 Comparison 10 Hemiarthoplasty: EPOCA prosthesis versus HAS prosthesis, Outcome 3 Range of motion results at one year (degrees).
Range of motion results at one year (degrees)

StudyMeasureEPOCA prosthesis

n = 18
HAS prosthesis

n = 17
Reported significance

Fialka 2008Active forward flexionmean = 109°
range = 30° to 150°
mean = 62°
range = 20° to 110°
P < 0.001

Fialka 2008Active abductionmean = 101°
range = 30° to 150°
mean = 62°
range = 30° to 100°
P = 0.001

Fialka 2008Active external rotation in 90° abductionmean = 30°
range = 0° to 60°
mean = 17°
range = 0° to 40°
P = 0.01

Fialka 2008Active external rotation in 90° abductionmean = 45°
range = 0° to 70°
mean = 13°
range = 0° to 40°
P = 0.001

 
Comparison 11. Post-operative (percutaneous fixation) immobilisation for 1 week versus 3 weeks

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Neer score ≤ 80 points (unsatisfactory or failure) at 6 months1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Premature removal of Kirschner wires1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 12. Post-operative (hemiarthroplasty) mobilisation: early (2 weeks immobilisation) versus late (6 weeks)

Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size

 1 Oxford Shoulder Score at 1 year (adjusted: 0 to 100 best)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Constant shoulder score (at 1 year)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 Overall score (0 to 100: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Pain component (0 to 15: best))
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Activities of daily living component (0 to 25: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.4 Mobility component (0 to 40: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.5 Strength component (0 to 25: best)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Radiological assessment findings1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Nonunion (with bone resorption)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.2 Malunion
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.3 Greater tuberosity migration (all had severe pain at 6 & 12 months)
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

    3.4 Superior luxation of prosthesis
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Range of motion at 1 year1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Elevation (degrees)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    4.2 External rotation (degrees)
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 
Table 1. Surgical versus conservative treatment trials: brief characteristics

StudyParticipants
(Neer classification)
SurgeryConservative
(starting with)
Follow-up

Fjalestad 2010

 
50 patients with 3- or 4-part fractures

(Norway)
Open reduction and fixation with an interlocking plate device and metal cerclagesImmobilisation of the injured arm in a modified Velpeau bandage. Closed reduction in 8 patients.1 year so far (2 years in all)

Kristiansen 1988

 
30 patients with 31 with 2-, 3- or 4-part fractures
(Denmark)
Percutaneous reduction and external fixation

 
Closed manipulation and sling immobilisation2 years

Olerud 2011a60 patients with 3-part fractures (all had displaced surgical neck fracture)
(Sweden)
Open reduction and fixation with a PHILOS plate and non-absorbable suturesSling immobilisation2 years

Olerud 2011b55 participants with 4-part fractures
(Sweden)
Humeral head replacement with the Global Fx prosthesisSling immobilisation2 years

Stableforth 198432 participants with 4-part fracture
(UK)
Hemi-arthroplastyClosed manipulation and sling6 months

Zyto 1997 40 patients with 3- or 4-part fractures (3 others excluded)
(Sweden)
Internal fixation using surgical tension band or cerclage wiringSling immobilisation50 months

 
Table 2. Assessment of items relating to applicability of trial findings

Clearly defined study population?Interventions sufficiently described?Main outcomes sufficiently
described?
Appropriate timing of outcome measurement?
(Yes = ≥ 1 year)

Agorastides 2007Partial: exclusions not specified upfrontYesYesYes: 1 year

Bertoft 1984Partial: no exclusion criteria given (e.g. ability to understand instructions for exercises)YesYesYes: 1 year

Fialka 2008YesYesYesYes: 1 year

Fjalestad 2010YesYesYesYes: 2 years

Hoellen 1997Yes: but some question over fracture type in that the Holbein 1999 report included 3-part fractures tooYesYesYes: 1 year

Hodgson 2003YesYesYesYes: 2 years

Kristiansen 1988Partial: no exclusion criteria givenPartial: incomplete description of timing of sling use and care of external fixator pin sitesPartial: no description of measurement proceduresYes: 1 year

Kristiansen 1989Partial: no exclusion criteria givenPartial: although sling and body bandage are common expressions, some variation possiblePartial: no description of measurement proceduresYes: 2 years

Lefevre-Colau 2007YesYesYesPartial: 6 months

Livesley 1992Yes: although this included 4 patients under 20 years with epiphyseal fracturesYesYesPartial: 6 months

Lundberg 1979Partial: no exclusion criteria given (e.g. ability to understand instructions for exercises)YesYesYes: 1 year or above (mean: 16 months)

Ockert 2010Partial: exclusion criteria described in context of post-randomisation exclusions.YesYesPartial: 6 months

Olerud 2011aYesYesYesYes: 2 years

Olerud 2011bYesYesYesYes: 2 years

Revay 1992YesPartial: frequency of swimming sessions not statedYesYes: 1 year

Rommens 1993Yes: but to note that other fractures including rib (3 participants) were includedYesPartial: functional outcome assessment not described (sufficiently)No: only until fracture consolidation

Smejkal 2011YesPartial: Only minimal intra-operative details given and nothing regarding post-operative management including rehabilitationPartial: this may have been ‘lost in translation’ (Czech article)Yes: mean 2 years but range not stated (probably most / all > 1 year as recruitment had finished January 2010).

Stableforth 1984YesYesPartial: no description of measurement procedures, incomplete description of pain categoriesPartial: up to 6 months, then between 18 months to 12 years. This is too spread out. Most results applied to the 6 month follow-up.

Voigt 2011YesYesYesYes: 1 year

Wirbel 1999YesYesPartial: no description of measurement proceduresPartial: between 9 and 36 months; < 1 year in 10 participants. Main results applied to 6 months.

Zhang 2011YesYesPartial: Insufficient information on measurement of complications and timing of their measurement.Yes: All over 25 months (mean 30.8 months)

Zhu 2011YesYesYesYes: 1 and 3 years

Zyto 1997YesYesYesYes: 1 year, and 3 to 5 years