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Intervention Review

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Conservative interventions for treating middle third clavicle fractures in adolescents and adults

  1. Mário Lenza1,*,
  2. João Carlos Belloti2,
  3. Régis B Andriolo3,
  4. Flávio Faloppa2

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 30 MAY 2014

Assessed as up-to-date: 29 MAY 2014

DOI: 10.1002/14651858.CD007121.pub3


How to Cite

Lenza M, Belloti JC, Andriolo RB, Faloppa F. Conservative interventions for treating middle third clavicle fractures in adolescents and adults. Cochrane Database of Systematic Reviews 2014, Issue 5. Art. No.: CD007121. DOI: 10.1002/14651858.CD007121.pub3.

Author Information

  1. 1

    Hospital Israelita Albert Einstein, Orthopaedic and Trauma Department, São Paulo, Sao Paulo, Brazil

  2. 2

    Universidade Federal de São Paulo, Department of Orthopaedics and Traumatology, São Paulo, São Paulo, Brazil

  3. 3

    Universidade do Estado do Pará, Department of Public Health, Belém, Pará, Brazil

*Mário Lenza, Orthopaedic and Trauma Department, Hospital Israelita Albert Einstein, Av. Albert Einstein, 627/701, São Paulo, Sao Paulo, CEP 05651-901, Brazil. mariolenza@yahoo.com.br. mario.lenza@einstein.br.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 30 MAY 2014

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This is not the most recent version of the article. View current version (15 DEC 2016)

 
Characteristics of included studies [author-defined order]
Andersen 1987a

MethodsStudy design: randomised controlled trial

Duration of the study: June 1981 to September 1982

Protocol was published before recruitment of patients: not reported

Details of trial registration: not reported

Funding sources: not reported


ParticipantsLocation: Denmark

Number of participants (N): 79 participants with acute middle third clavicle fractures

Inclusion criteria:

  • People with middle third clavicle fractures
  • Aged > 13 years
  • Patient informed consent


Exclusion criteria:

  • Perforation of the skin or primary neurovascular symptoms


Age (median (range)): figure-of-eight = 19 years (14 to 81); sling = 19 years (14 to 66)

Gender: not specified

Side: not specified

Classification of injury: not specified, just fracture types (2 fragments, 1 intermediary fragment and 2 or more intermediary fragments) and fracture dislocations (undisplaced, minor displacement, major displacement)

Assigned: 45/34 (figure-of-eight/sling)

Assessed: 34 at median period of 12 weeks (10 to 16)/27 at median period of 13 weeks (10 to 17) (figure-of-eight/sling)


InterventionsTiming of intervention: after diagnosis

Duration of treatment: 3 weeks

Duration of rehabilitation: not specified

Intervention 1 (figure-of-eight bandage):

After 2 days, and 1 and 2 weeks, this method was checked and adjusted by participant's own general practitioner. This immobilisation was used for 3 weeks. All participants were stimulated to move the shoulder as soon as possible

Intervention 2 (arm sling):

Simple sling was used only as long as the patient felt a need for it. All participants were stimulated to move the shoulder as soon as possible


OutcomesLength of follow-up:

The figure-of-eight group lasted a median interval of 12 weeks (10 to 16) and the sling group lasted a median interval of 13 weeks (10 to 17); the figure-of-eight group also was assessed at 2 days, 1 and 2 weeks

Outcomes:

  1. Shoulder function; this was assessed using a non-validated score
  2. Pain: use of analgesics and duration of pain
  3. Adverse events: deformity at fracture site, skin problems, neurovascular symptoms, impairment of shoulder motion, weakness of shoulder muscles, pain from movement and tenderness of fracture site; other complications (not specified)
  4. Radiographic outcomes: healing of fracture, amount of callus and displacement
  5. Patient satisfaction with type of treatment
  6. Other outcomes: duration of bandaging, discomfort from treatment, severity of discomfort, duration of discomfort, number of visits to general practitioner, duration of functional impairment, duration of sick leave/disablement


Notes11 participants in the figure-of-eight group were withdrawn from the study

  • 1 = refused bandage
  • 1 = bandage removal
  • 1 = DVT
  • 2 = fracture displacement
  • 6 = defaulted the follow-up examination


7 participants in the sling group were withdrawn from the study

  • 1 = confined to bed (5 weeks)
  • 1 = treatment with Velpeau (1week)
  • 1 = suffered hemiplegia
  • 4 = defaulted on follow-up examination


The outcomes were evaluated by a non-validated scoring system


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskRandom numbers table was used

Allocation concealment (selection bias)Unclear riskDetails to ascertain that allocation was concealed were not provided

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcomes assessors were not blinded

Incomplete outcome data (attrition bias)
All outcomes
High riskLess than 80% of participants completed the follow-up (23% of withdrawals)

Selective reporting (reporting bias)High riskThe authors used non-validated scores to assess function and pain; treatment failure was not reported

Other biasUnclear riskInsufficient information to permit judgement

Hoofwijk 1988

MethodsStudy design: randomised controlled trial

Duration of the study: December 1983 to May 1987

Protocol was published before recruitment of patients: not reported

Details of trial registration: not reported

Funding sources: not reported


ParticipantsLocation: Department of Surgery, Saint Elisabeth Hospital, Tilburg, The Netherlands

Number of participants (N): 155 participants with 157 acute middle third clavicle fractures

Inclusion criteria:

  • People with middle third clavicle fractures and outpatient treatment
  • Aged > 14 years
  • Agreement of the patient


Exclusion criteria:

  • People with re-fractures
  • Open fractures
  • Concomitant injuries of vessels or nerves or on the same extremity


Age (mean/SD): figure-of-eight bandage: 24.4/12.5 years; arm sling: 25.4/14.5 years

Gender (female/male): figure-of-eight bandage: 22/56; arm sling: 22/57

Side (left/right): 85/72

Classification of injury: not specified, just fracture displacement (undisplaced and displacement) and multiple fragment fractures (with or without shortening)

Assigned: 78/79 (figure-of-eight bandage/arm sling)

Assessed: 74/78 at mean period of 10 (6 to 36) months (figure-of-eight bandage/arm sling)


InterventionsTiming of intervention: after diagnosis

Duration of treatment: not known, probably 3 weeks

Duration of rehabilitation: not specified

Intervention 1 (figure-of-eight bandage):

Details not specified

Intervention 2 (arm sling):

Details not specified


OutcomesLength of follow-up:

Length of follow-up was a mean of 10 months (range 6 to 36 months). Follow-up was conducted on the first and third day after the accident, after 1, 2 and 3 weeks, and after at least 6 months

Outcomes:

  1. Shoulder function, evaluated using a non-validated score
  2. Pain: VAS at 1.8 and 15 days; and analgesic consumption
  3. Clinical healing (time to consolidation): consolidation clinically
  4. Adverse events: poor cosmetic appearance, radiographic outcomes reported (shortening and displacement post fracture union) but participant numbers not available for these
  5. Return to school/work and sports activities


Notes4 participants in the figure-of-eight bandage group were withdrawn from the study (could not be found)

1 participant in the arm sling group was withdrawn from the study (could not be found)

Radiographic outcomes were not analysed in the review because participant numbers for each intervention were not known despite contacting the authors


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Unclear riskInsufficient information about the sequence generation process to permit judgement

Allocation concealment (selection bias)Unclear riskParticipants were randomised to the 2 treatment groups by opening of pre-numbered envelopes; however, details to ascertain that allocation was concealed were not provided

Blinding of participants and personnel (performance bias)
All outcomes
High riskParticipants and personnel were not blinded

Blinding of outcome assessment (detection bias)
All outcomes
High riskOutcomes assessors were not blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskMore than 80% of participants completed the follow-up, missing outcomes data were balanced in number across intervention groups and an intention-to-treat analysis was likely, but outcome data for participants who had withdrawn from the trial or were lost to follow-up were not presented

Selective reporting (reporting bias)High riskThe authors used non-validated scores to assess function and treatment failure was not reported

Other biasUnclear riskInsufficient information to permit judgement

Lubbert 2008

MethodsStudy design: multi-centre, double-blind randomised controlled trial

Duration of the study: March 2001 and December 2003

Protocol was published before recruitment of patients: not reported

Details of trial registration: not reported

Funding sources: data collection and data analysis were supported by a financial grant from Smith and Nephew Inc, Memphis, USA. Transducers (placebo and active) were provided free of cost. No author had any financial or personal relationships with people or organisations that could inappropriately influence their work


ParticipantsLocation: 6 hospitals in the Netherlands participated in the study (Meander Medical Centre, Amersfoort; Onze Lieve Vrouwen Gasthuis Hospital, Amsterdam; Reinier de Graaf Hospital, Delft; Saint Antonius Hospital, Nieuwegein; Diakonessen Hospital, Utrecht; University Medical Centre Utrecht, Utrecht)

Number of participants (N): 120 participants with acute middle third clavicle fractures

Inclusion criteria:

  • People with middle third clavicle fractures
  • Acute fracture (< 5 days)
  • Aged ≥ 18 years
  • Monotrauma
  • Understanding of Dutch language and written informed consent


Exclusion criteria:

  • Aged < 18 years
  • Multiple trauma
  • Re-fracture
  • Pathological fracture
  • Open fracture or imminent skin perforation
  • Metaphysis fracture
  • No possibilities for follow-up


*Age (mean/SD): LIPUS: 37.69/12.886; control (placebo): 36.92/12.339

Gender (female/male): LIPUS: 6/46; control (placebo): 10/39

Side (left/right): LIPUS: 32/20; control (placebo): 22/27

Classification of injury: AO system (A1, A2, A3, B1, B2, B3, C1, C2, C3)

Assigned: 61/59 (LIPUS/control (placebo))

Assessed: 52/49 (LIPUS/control (placebo)). *Follow-up ranged between 12 and 43 months

*Data assessed by personal contact with the authors


InterventionsTiming of intervention: up to 5 days after the diagnosis

Duration of treatment (mean): LIPUS = 25.38 days; control (placebo) = 24.43 days (mean difference 0.95, 95% CI -3.72 to +1.81, P = 0.49)

Duration of rehabilitation: it was not done

All participants were treated with passive support for their own convenience. Free arm movements within pain range were allowed from day 1

Intervention 1 (LIPUS):

LIPUS delivers an ultrasound signal intensity of 30 mW/cm2 SATA, with a burst width of 200 µs in 1.5 MHz sine waves, pulsed at 1 kHz

Intervention 2 (placebo):

Control (placebo): transducers produced no signal, but showed similar messages on the display screen and could not be distinguished from active transducers


OutcomesLength of follow-up:

Length of follow-up (mean): LIPUS 29.64 months and placebo 30.08 months, ranged between 12 and 43 months*. All participants were seen in the outpatient clinic approximately 1 week after starting the treatment and again roughly 2, 4, 6 and 8 weeks after trauma

Outcomes:

  1. Pain: pain (VAS), analgesics consumption
  2. Treatment failure
  3. Clinical healing (time to consolidation)
  4. Adverse events: skin irritation (other "minor adverse side effects" not enumerated)
  5. Time to return to household activities, work and sport


* Data assessed by personal contact with the authors


Notes9 participants in the LIPUS group were withdrawn from the study (diary not completely filled)

10 participants in the control group were withdrawn from the study (7 diary not completely filled and 3 transducer failure)


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskBlock randomisation was used

Allocation concealment (selection bias)Low riskDouble-blind, randomised, placebo-controlled trial

Each participating hospital was delivered consecutive numbered transducers in packs of 4 (2 LIPUS and 2 placebos)

Blinding of participants and personnel (performance bias)
All outcomes
Low riskParticipants and personnel were blinded

Blinding of outcome assessment (detection bias)
All outcomes
Low riskOutcomes assessors were blinded

Incomplete outcome data (attrition bias)
All outcomes
Low riskMore than 80% of participants completed the follow-up, missing outcomes data were balanced in number across intervention groups, and an intention-to-treat analysis was reported for the primary outcomes; however, data for those patients who withdrew were not reported

Selective reporting (reporting bias)High riskThe study protocol is not available and function and/or disability were not evaluated using a validated score

Other biasLow riskThe study appears to be free of other sources of bias

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Bajuri 2011This was a prospective cohort study

Roberti 2008This study, which was registered in the Netherlands trial register, was listed as an ongoing trial in the first version of the review. It planned to compare Kinesio(R) tape plus sling versus sling alone, with a start date of October 2008 and end date October 2010. However, the contact author reported that for a variety of reasons the trial was ended and no data are available

Talbot 2008This study, logged in the National Research Register (UK), was intended to be a randomised trial of shoulder brace versus arm sling in 100 adults with isolated closed middle third clavicle fractures. It was planned to start in April 2002; however, the contact author indicated that for a variety of reasons this study never took place

Thompson 2005Not a randomised or quasi-randomised controlled trial

 
Comparison 1. Figure-of-eight bandage versus arm sling

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

 1 Shoulder function: number of participants with 'good function'1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Pain: visual analogue scale (0 (no pain) to 10 (worst pain))1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    2.1 Pain on 1st day
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.2 Pain on 8th day
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    2.3 Pain on 15th day
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 3 Pain: duration of painkiller consumption (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 4 Clinical healing: time to clinical fracture consolidation (weeks)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 5 Adverse event: poor cosmetic appearance post fracture healing1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 6 Adverse event: worsened fracture position on healing1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 7 Time to return to previous activities (weeks)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    7.1 Resumption of school/work
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    7.2 Resumption of sports activities
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

 8 Patient dissatisfaction with course of treatment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 2. Low-intensity pulsed ultrasound versus placebo

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

 1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain))1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Pain: number of painkillers (tablets/28 days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Treatment failure1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Number who had surgical procedure
1Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]

 4 Clinical healing: time to clinical fracture consolidation (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 5 Adverse events: skin irritation1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 6 Time to return to previous activities (days)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 Resumption of household activities
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.2 Resumption of professional work
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]

    6.3 Resumption of sport
1Mean Difference (IV, Fixed, 95% CI)0.0 [0.0, 0.0]