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Conservative interventions for treating distal radial fractures in adults

  1. Helen HG Handoll1,*,
  2. Rajan Madhok2

Editorial Group: Cochrane Bone, Joint and Muscle Trauma Group

Published Online: 22 APR 2003

Assessed as up-to-date: 21 AUG 2005

DOI: 10.1002/14651858.CD000314


How to Cite

Handoll HHG, Madhok R. Conservative interventions for treating distal radial fractures in adults. Cochrane Database of Systematic Reviews 2003, Issue 2. Art. No.: CD000314. DOI: 10.1002/14651858.CD000314.

Author Information

  1. 1

    University of Teesside, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, Middlesborough, Tees Valley, UK

  2. 2

    University of Manchester, Cochrane Bone, Joint and Muscle Trauma Group, Manchester, UK

*Helen HG Handoll, Centre for Rehabilitation Sciences (CRS), Research Institute for Health Sciences and Social Care, University of Teesside, School of Health and Social Care, Middlesborough, Tees Valley, TS1 3BA, UK. h.handoll@tees.ac.uk. H.Handoll@ed.ac.uk.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 22 APR 2003

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Characteristics of included studies [ordered by study ID]
Abbaszadegan 1989

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: unknown (baseline data not given)
Lost to follow up: 12 (15%)


ParticipantsTeaching hospital, Sweden
80 participants
Inclusion criteria: minimally displaced Colles' fracture, dorsal angulation < 95 degrees (see notes) or axial shortening < 2 mm
Exclusion criteria: not stated
Classification: Lidstrom (I & II), Frykman (I to VII, not VI), extra-articular and intra-articular
Sex: 57 female (of 68)
Age: of 68: mean 62 years; range 19 - 91 years
Allocation: ?/? [elastic / POP]
Assessed: 34/34


InterventionsTiming of intervention: not stated. No reduction performed.
(1) Elastic bandage (“functional treatment”) for 4 weeks.
(2) Dorsal plaster cast for 4 weeks.
All participants received information about finger and shoulder mobilisation.


OutcomesLength of follow up: 1 year; also 11 days, 4 and 8 weeks
(1) Anatomical: X-ray initially and at 11 days, 8 weeks. Dorsal angulation, radial shortening.
(2) Functional: Pain (VAS), grip strength, range of movement. Combined score of functional outcomes [Lidstrom].
(3) Clinical:
Complications:
Fracture dislocation: no data
Median nerve decompression: 1/0 [elastic / POP]
Pressure sores: 0/4 (all needed cast change)


NotesDorsal angulation was calculated on the "lateral projection as the angle between the joint surface of the radius and the long axis of the radial shaft".


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Aladin 2001

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: unknown, likely unit of analysis problems
Lost to follow up: not known


ParticipantsTeaching Hospital, UK
126 participants with 128 fractures
Inclusion criteria: displaced Colles' fractures
Exclusion criteria: not stated
Classification: not stated
Sex: not stated (both)
Age: no details
Assigned: 65/63 (fractures) [sugar-tong POP / below-elbow POP]
Assessed: ?/?


InterventionsTiming of intervention: not known. Reduction using Chinese finger-trap method.
Duration of treatment not known, probably 5 weeks
(1) Modified sugar-tong plaster cast where forearm rotation is blocked. Some flexion / extension allowed at elbow
(2) Below-elbow cast


OutcomesLength of follow up: 5 weeks; also 1 week.
(1) Anatomical: X-ray immediately post manipulation, and at 1 and 5 weeks. Dorsal tilt, radial shortening, radial angle and carpal malalignment. 'Acceptable' position (dorsal tilt < 10 degrees, radial shortening < 5 mm).
(2) Functional: none
(3) Clinical:
Complications:
Redisplacement: 43 (66%)/ 43 (69%) [sugar-tong POP / below-elbow POP]


NotesAbstract only
Results probably given for fractures rather than patients. Two participants had two wrist fractures. Estimates of numbers from percentages presented in report are based on the assumption of no losses.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Blatter 1994

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: not known
Lost to follow up: 0 (inferred)


ParticipantsGeneral hospital, Switzerland
50 participants
Inclusion criteria: closed displaced distal radial fracture, AO classification A2.2, A3.2, C1.2 & C2.2
Exclusion criteria: not stated
Classification: AO (see above); extra- and intra-articular
Sex: 37 females
Age: not stated (some < 30 years, others > 50 years)
Assigned: 25/25 [neutral / dorsal flexion]
Assessed: 25/25


InterventionsTiming of intervention: not stated.
Closed MUA. All reduction performed under regional analgesia.
(1) POP dorso-radial slab with wrist in neutral position. POP completed 5-9 days later.
(2) POP dorso-radial slab with wrist in dorsal position (20 degrees flexion). POP completed 5-9 days later.
Total immobilisation for 4 weeks for both groups.


OutcomesLength of follow up: 2 years minimum [range 2-7 years]
(1) Anatomical: X-ray pre and post manipulation, at plaster completion (5-9 days) and at 2 years. Radial shortening, radial angle and dorsal angulation
(2) Functional: range of wrist movement and grip strength, subjective assessment of disability.
(3) Clinical: patient satisfaction with POP.
Complications:
Discomfort with plaster (pressure pain) 3/8 [neutral / dorsal flexion]


NotesGerman paper: full translation obtained.
Adequacy of reduction different between groups for radial angle parameter.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Bunger 1984

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: problems; 5 exclusions due to withdrawal and personal circumstances
Lost to follow up: 14 (9%)


ParticipantsRegional hospital, Denmark
150 participants
Inclusion criteria: Colles' fracture - all grades undisplaced and displaced (criteria given).
Exclusion criteria: ipsilateral fractures of arm, multiple trauma, previously impaired neuromotor function of fractured wrist.
Classification: Frykman (I-VIII); extra-articular and intra-articular
Sex: (of 145) 125 female
Age: not stated
Assigned: 68/82 [brace / POP]
Assessed: 64/72


InterventionsTiming of intervention: not stated.
Reduction of displaced fracture under local anaesthesia.
(1) Above elbow POP splint with forearm in supination. Replaced at 1 week by functional brace (PVC / Hexcelite) in supination. Brace removed at 5 weeks.
(2) Below-elbow POP (undisplaced, stable displaced), POP including elbow, with forearm in pronation (unstable displaced). Replaced at 12 days by POP dorsal splints with wrist in neutral flexion. (Mention of post-reduction Cotton-Loder position in 1983 abstract.) Total immobilisation for 6 weeks.


OutcomesLength of follow up: 6 months; also at 1 day, 2 and 7 weeks and 3 months post MUA.
(1) Anatomical: X-ray pre and post manipulation, and at 1, 2 and 6 weeks. Radial length, radial angulation, dorsal angulation, dorsal shift, radial shift. Combined score [Lidstrom]
(2) Functional: 7 weeks, 3 and 6 months. Combined score [modified Gartland and Werley]: including residual deformity, subjective evaluation (pain, limitations), objective evaluation (grip strength etc), complications. Also ROM and grip strength.
(3) Clinical:
Complications: paraesthesia, finger motion, arthritic changes (within functional score). Early:
Redisplacement: 16/38 [brace / POP]
Rereduction at 2 weeks: 4/7
Median neuropathy: 2/2
Temporary upper limb dystrophy: 3/2
Peripheral radial/ulnar neuropathy: 3/3
Radioulnar pain: no difference


NotesAbstract in 1982 reports trial of 81 people: either subgroup analysis or interim report assumed.
Abstract (1983) reported 150 participants in the trial; there had been some ambiguity in the main report as to whether 5 excluded participants were from 145 or 150 in all: thus, resolved.
Copy of report in Danish (Bunger 1985) not obtained. The Solund 1983 reference gives data for the overall population.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Christensen 1995

MethodsRandomisation by date of presentation (quasi-RCT)
Assessor blinding: not reported
Intention to treat: not known
Lost to follow up: not stated


ParticipantsTeaching hospital, Denmark
33 participants
Inclusion criteria: undisplaced distal radial fracture, Older type 1 and 2, dorsal angulation </= 10 degrees, axial radial shortening </= 4 mm
Exclusion criteria: previous radial fracture of same side, neurological disorders.
Classification: Older (1 & 2)
Sex: 28 female
Age: mean 62 years; range 29-84 years
Assigned: 19/14 [3 weeks POP/ 5 weeks POP]
Assessed: 19/14 (assuming no losses)


InterventionsTiming of intervention: not stated.
Dorsal plaster slab with forearm in pronation, wrist in palmar / ulnar flexion.
(1) Immobilisation for 3 weeks
(2) Immobilisation for 5 weeks


OutcomesLength of follow up: 9 months; also at 3 months.
(1) Anatomical: X-ray pre-cast and 3 months. Radial length, radial angulation, dorsal angulation.
(2) Functional: 3 and 9 months. Combined score [modified Gartland and Werley]: including residual deformity, subjective evaluation (pain, limitations), objective evaluation (grip strength etc), complications.
(3) Clinical: complications (in functional score)


NotesNo data available for quantitative analysis.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Cohen 1997

MethodsMethod of randomisation: not stated, stratified by severity of fracture
Assessor blinding: independent evaluation of cast fit and blinded and independent assessment of radiological outcomes
Intention to treat: likely, not known
Lost to follow up: not known, probably none


ParticipantsTeaching hospital, USA
30 people with distal radius fracture
Inclusion criteria: unilateral distal radius fracture from fall from standing height or less. Treatable by cast with or without percutaneous pins. Within 5 days from injury. Undisplaced and displaced fractures.
Exclusion criteria: fractures requiring open reduction or external fixation devices.
Classification: own classification - Grade I , II, II, based on displacement and stability.
Sex: 22 female
Age: mean 57 years, range 19-89 years
Assigned: 15/15 [Quickcast / fibreglass]
Assessed: 15/15


InterventionsTiming for intervention: within 5 days of injury. Reduction under local anaesthesia for 10 displaced fractures. Cast application was during operation for 10 unstable fractures requiring percutaneous pin fixation.
(1) Short-arm Quickcast (TM) - shrinkable polymer-coated casting material. Applied using warm air.
(2) Short-arm fibreglass tape cast
Casts worn 5.5 to 6.5 weeks.


OutcomesLength of follow up: not stated - until cast removal? Seen at 10-14 day intervals
(1) Anatomical: X-ray after reduction, and 10-14 day intervals. Radial length and inclination, ulnar variance, volar tilt. Fracture displacement.
(2) Functional: not stated
(3) Clinical:
Patient satisfaction with cast
Complications:
During last use:
Burns during application: 2/0 [Quickcast / fibreglass]
Discomfort at base of thumb: 4/3
Discomfort near elbow: 1/0
Loosening / discomfort - early cast change: 2/2
Fracture redisplacement: 2/1
Fracture rereduction: 1/0
(4) Resource use:
Cost of casting material
Cast changes


Notes10 participants, classed as having displaced unstable fractures, had percutaneous pin fixation. However, the results for these could not be separated from the overall group.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Cohen 2001

MethodsRandomisation by numbered sealed consecutively opened envelopes
Assessor blinding: maybe (ROM and grip strength post cast removal) but not claimed as such
Intention to treat: some problems with exclusions but additional information received
Lost to follow up: 1 (3%)


ParticipantsDistrict hospital, UK
35 people with distal radius fracture (of 200 patients with arm and leg injuries in trial)
Inclusion criteria: Minimally or undisplaced distal radial fracture, stable configuration, fresh injury, informed consent
Exclusion criteria: < 16 years, psychiatric morbidity, in police custody, surgery indicated
Classification: none
Sex: not stated (108 females in overall group)
Age: not stated (range 16-84 years in overall group)
Assigned: 14/21 [Focused rigidity cast / complete POP or synthetic cast] (see Notes)
Assessed: 14/20 (14/15 in paper Cohen 2001)


InterventionsTiming of intervention: randomised at first attendance at fracture clinic.
(1) Focused rigidity cast (elasticated synthetic tape applied to confer relative rigidity at fracture site with more flexibility elsewhere). Cast removed 4 weeks (21-42 days)
(2) Synthetic cast or, in 6 participants, circular POP (see Notes). POP back slab initially applied for latter 6 participants as they had very swollen wrists. Cast removed 4 weeks (14-40 days)


OutcomesLength of follow up: just after cast removal (mean 4 weeks).
(1) Anatomical: non-union, loss in position
(2) Functional: at 4 weeks. Movement limitations, muscle power. During cast-use ADL subjective scoring scheme (ADL, satisfaction, comfort) [own scheme: Bradford Plaster Index]
(3) Clinical:
Patient satisfaction with cast
Complications:
Discomfort in cast: 1/0 [Focused rigidity cast / complete POP or synthetic cast]
Loss in fracture position: 0/0
Manipulation: 0/0
Non-union: 0/0
Other complications: 0/0
(4) Resource use:
Referral for physiotherapy (no data), cast replacement, cast adjustment


NotesExtra details on trial and separate data for wrist fracture patients provided by Andrew Cohen (28/02/02). Some information contradicted trial report: in particular whether synthetic or a full POP cast was used for some patients.

Copy of earlier paper (Petty 1998) provided by Mr Shaw. Some discrepancies with later report: wrist injuries: 20 versus 15 instead of 14 versus 21. Request for further clarification sent 26 August 2002.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Cornwall 2001

MethodsMethod of randomisation: not stated
Assessor blinding: yes, radiological measurements by a blinded observer
Intention to treat: not known
Lost to follow up: not known (24 (34%) reported for interim analysis of 70 participants)


ParticipantsHospital, USA
127 participants
Inclusion criteria: adults with acute closed distal radius fractures - not defined. Some Frykman VIII fractures and mention of articular step-off measurements thus some were intra-articular. Also reduction where necessary so at least some were displaced.
Exclusion criteria: not stated
Classification: Frykman, AO and Fernandez performed (no details)
Sex: not stated
Age: no details but adults
Assigned: ?/? [above-elbow / below-elbow]
Assessed: ?/?


InterventionsTiming of intervention: not known, but acute fractures. Reduction where necessary.
Duration of treatment not known.
(1) Above-elbow cast; neutral forearm rotation
(2) Below-elbow cast


OutcomesLength of follow up: until union; mean 41 days.
(1) Anatomical: X-ray pre and post manipulation, 6 and 15 days and at fracture healing. Volar tilt, radial length, radial inclination and articular step-off.
(2) Functional: none
(3) Clinical: none
Complications: not stated


NotesAbstracts only
No discrete data
Abstract report in 2000 presented interim results for 70 people.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Davis 1987

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: unlikely - post randomisation exclusions
Lost to follow up: 3 (5%)


Participants2 district hospitals, UK
55 participants with 56 fractures
Inclusion criteria: minimally displaced closed distal radius fracture with < 10 degrees dorsal angulation
Exclusion criteria: < 18 years, open fracture, multiple injuries, styloid fractures
Classification: not stated: extra- and intra-articular (6/54) fractures
Sex: 43 female (of 54 fractures)
Age: mean 56 years (of 54 fractures)
Assigned: 28/28 fractures [DTG / POP]
Assessed: 27/25 [after exclusions]


InterventionsTiming of intervention: 7-14 days.
Below-elbow back slab for 7-13 days.
(1) Double tubigrip bandage (DTG) during the day for 3 weeks
(2) POP cylinder with immobilisation for 3 weeks


OutcomesLength of follow up: 7 weeks; also at 1 day post MUA and 5 weeks.
(1) Anatomical: X-ray pre-treatment and 5 weeks. Dorsal angulation.
(2) Functional: 2, 5 and 7 weeks. Range of wrist movement, grip strength, pain, domestic tasks. Combined score grades [Gartland and Werley]
(3) Clinical: patient satisfaction.
Complications:
Dorsal displacement: 2/3 [DTG / POP]
Withdrawal from treatment: 0/2
Treatment failure: 1/1
Cosmetic deformity: 0/2
EPL rupture: 0/1
Shoulder stiffness: 1/0
Physiotherapy required: 1/3
Persistent paraesthesia: 7/7


NotesResults given for fractures rather than patients. One participant had bilateral wrist fractures.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

De Bruijn 1987

MethodsTwo sequential trials
Randomisation by date of attendance in first trial. Numbered forms, ratio 3/1 [functional brace or bandage / Sarmiento brace] used for the second trial. Quasi-RCTs.
Assessor blinding: not reported
Intention to treat: no, data merged incorrectly from both trials; also some exclusions (including missed follow up etc) applied after trial entry.
Lost to follow up: 52 for both trials (21%)


ParticipantsTeaching hospital, The Netherlands
248 people participated in 2 trials
Inclusion criteria: Colles' fracture with united epiphyseal plates
Exclusion criteria: open epiphysis, ipsilateral fracture, fracture > 3 days old, bilateral fractures, multiple injuries, previous fracture, pre-existing limb impairment, follow-up elsewhere. (Withdrawal: inability to cooperate, 2 missed follow-up appointments, < 5 degrees volar angle post-reduction.)
Classification: Sarmiento (types 1 to 4); extra-articular and intra-articular fractures
Sex: 152 female of 196
Age: not stated
Assigned: ?/104 [Sarmiento brace / POP]; 56/? [functional brace or bandage / Sarmiento brace]
(Total Sarmiento: 88)
Assessed: ?/82 [Sarmiento brace / POP]; 47/? [functional brace or bandage / Sarmiento brace]
(Total Sarmiento: 67)


InterventionsTiming of intervention: at reduction and 1 week post-reduction.
Displaced fractures manipulated with haematoma block.
Trial 1:
(1) Above-elbow POP backslab with forearm in supination for 1 week, changed to a Sarmiento's brace in supination for 3 weeks
(2) Below-elbow POP backslab for 4 weeks
Trial 2:
(1) Below-elbow POP backslab then functional below-elbow brace with restricted dorso-radial movement for 3 weeks (displaced fractures), or bandage for 3 weeks (undisplaced).
(2) Above-elbow POP backslab with forearm in supination for 1 week, changed to a Sarmiento's brace in supination for 3 weeks


OutcomesLength of follow up: 1 year; also day 1, 7 and 14, and 4, 6, 10, 14 and 26 weeks
(1) Anatomical: X-ray pre and post manipulation and 1 and 2 weeks. Radial length and angle, and volar angle.
(2) Functional: range of movement, pain and grip strength, motor functions of hand (activities of daily living)
(3) Clinical: cosmetic appearance. Signs and symptoms.
Complications: pressure sores, rereduction, nerve & tendon injury, Sudeck's syndrome, post-traumatic arthritis, Dupuytren's contracture, carpal tunnel compression, equipment problems.


NotesComprehensive thesis.
Data incorrectly combined from 2 trials which had one intervention in common (Sarmiento brace). Non concurrent interventions compared.
Baseline data not available.
Discrete data were not given for "bandage" group


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Dias 1987

MethodsRandomisation by dates of birth (Quasi-RCT)
Assessor blinding: independent and blinded observer at 13 weeks for functional assessment
Intention to treat: no (according to trialist)
Lost to follow up: not known (none?)


ParticipantsTeaching hospital, UK
187 participants
Inclusion criteria: closed unilateral Colles' fracture, displaced (reduction required) and undisplaced, > 55 years, no past history of hand/wrist injury, no generalised joint disease
Exclusion criteria: injury to other hand / wrist, unable to perform daily activities
Classification: not stated, displaced/undisplaced
Sex: 161 female
Age: mean 67 years, range 55-98 years
Assigned: 50/47/43/47 [undisplaced crepe / undisplaced POP / displaced modified POP/ displaced POP]
Assessed: 50/47/43/47


InterventionsTiming of intervention: on first visit to A&E department.
Timing of MUA not stated.
Undisplaced fractures allocated to treatment in either:
(1) Crepe bandage and early mobilisation during the day for 3 weeks
(2) POP cylinder for 5 weeks
Displaced fractures (clinically visible deformity) allocated to treatment by:
(3) Modified POP cylinder allowing greater wrist mobility (extension restricted) for 5 weeks. Velcro strap fixed across palm at night to restrict hand movement.
(4) POP cylinder for 5 weeks


OutcomesLength of follow up: 3 months; also at 1 day post MUA, 1, 5 and 9 weeks post MUA
(1) Anatomical: X-ray at each follow-up time. Radial length, deviation and shift, volar tilt measured [Lidstrom]
(2) Functional: 5 weeks and 3 months. Range of wrist movement, grip strength, pain (VAS), analgesia use, night pain and wrist circumference [Stewart et al]. Also functional score [Gartland and Werley]
(3) Clinical:
Complications: No data; wrist swelling, deformity, discomfort


NotesFull report plus abstract. Abstract reports on minimally displaced fracture group only.
Some information on methodology obtained from trialist.
The entry used to state that "All reduction performed under regional analgesia." but subsequently we have failed to find written records of this, though it is likely.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Ferris 1989

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: problems
Lost to follow up: 13 (declared), 8 in analysis (17%)


ParticipantsTeaching hospital, UK
47 participants (see notes)
Inclusion criteria: closed Colles' fracture [not defined]
Exclusion criteria: < 16 years, inability to follow instructions.
Classification: not stated
Sex: 2/3rd female
Age: mean 60 years; range 22-87 years
Assigned: 20/27 [brace / POP]
Assessed: 18/21


InterventionsTiming of intervention: not stated.
All reductions performed under regional analgesia.
(1) Closed MUA and a 4 part brace applied with wrist in supination. Limited wrist motion allowed (dorsi and palmar flexion). Total application for 5 weeks.
(20 Closed MUA and POP dorso-radial slab with forearm in pronation. POP completed within 48 hours. Total immobilisation for 5 weeks.


OutcomesLength of follow up: 9 weeks. Also at 1 day and 5 weeks post MUA.
(1) Anatomical: X-ray pre and post manipulation and 5 weeks. Radial shortening and dorsal angulation
(2) Functional: range of wrist movement and grip strength [Porter & Stockley] at 5 and 9 weeks
(3) Clinical:
Complications:
Swelling: 20/0 [brace /POP]
Remanipulation: 1/4
Sudeck's: 1/0 (responded to therapy)


NotesShort follow up.
Possibility that a few more patients were recruited than stated in report.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Gibson 1983

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: not known
Lost to follow up: not known


ParticipantsTeaching hospital, UK
105 participants
Inclusion criteria: Colles' fracture [not defined in abstract]. Displaced according to long-term report (see Notes).
Exclusion criteria: not stated
Classification: not stated
Sex: not stated
Age: not stated
Assigned: ?/?/?
Assessed: ?/?/?


InterventionsTiming of intervention: not stated. Closed reduction under IVRA.
(1) Functional bracing in supination (thermoplastic)
(2) Supinated above-elbow POP
(3) Pronated elbow POP
All participants were given physiotherapy to the non-immobilised joints. Immobilisation for 5 weeks.


OutcomesLength of follow up: 20 weeks
(1) Anatomical: X-ray pre and post manipulation and 1, 9 and 20 weeks
(2) Functional: at 9 and 20 weeks, no method detailed
(3) Clinical:
Complications: not detailed


NotesAbstract only.
No discrete data given.
Both named trialists contacted in August 2000. Informed of two papers associated with trial - both 10-year follow ups of the trial patients but data split by treatment group not provided. Some extra details of interventions and indication that all fractures were displaced. Also, there were discrepancies: e.g. only 100 participants reported rather than 105; follow up at 20 weeks not acknowledged nor the use of three types of splintage. Thus, no information has been used from these 2 long-term follow up reports in the assessment of this trial. One trialist commented that the supinated brace, advocated in the abstract, was not used subsequently because patients rejected it.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Gupta 1991

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: likely but not known
Lost to follow up: not stated


ParticipantsTeaching hospital, India
204 participants
Inclusion criteria: closed displaced Colles' fracture [not defined], included comminuted and non-comminuted extra-articular fractures, and intra-articular fractures.
Exclusion criteria: not stated
Classification: Own
Sex: 122 females
Age: mean 46 years; range 18-74 years
Assigned: 60/75/69 [palmar / neutral / dorsal position]
Assessed: 60/75/69


InterventionsTiming of intervention: not stated.
All reduction performed under intravenous sedation
Closed MUA and below-elbow plaster cast applied with:
(1) Wrist in palmar flexion for 6 weeks
(2) Wrist in neutral position for 6 weeks
(3) Wrist in dorsiflexion for 6 weeks
Intra-articular fractures for 5 rather than 6 weeks.
Wrist also held in slight ulnar deviation.


OutcomesLength of follow up: mean 15 months (range 5-24 months); also at 1 day and 10 days post MUA.
(1) Anatomical: X-ray pre and post manipulation, day 10 and final review. Radial length, radial deviation and volar tilt
(2) Functional: Combined outcome: overall grades [Sarmiento criteria] not stated when assessed (at final review?)
(3) Clinical:
Complications: not stated, joint stiffness mentioned.


Notes


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Ho 1986

MethodsMethod of randomisation: not stated, "randomly distributed"
Assessor blinding: not reported
Intention to treat: problems anticipated due to severe lost to follow-up
Lost to follow up: 70 at 6 months (63%)


ParticipantsTeaching hospital, Hong Kong, China
109 participants with 111 fractures
Inclusion criteria: age > 40 years with Colles' fracture [not defined]
Exclusion criteria: not stated
Classification: not stated
Sex: not stated
Age: not stated
Assigned: 42/69 [brace / POP]
Assessed: ?/?


InterventionsTiming of intervention: not stated, after closed reduction.
(1) Supinated long arm POP for 1-2 weeks, followed by Sarmiento's functional brace in supination for 4 weeks. Wrist palmar flexion and ulnar deviation allowed in brace
(2) Short arm POP for 6 weeks


OutcomesLength of follow-up: 6 months. Also at 6 weeks and 3 months post reduction.
(1) Anatomical: X-ray pre and post reduction, 1-2 weeks and 6 weeks. Radial length and shortening, dorsal angulation, radial angulation, dorsal shift.
(2) Functional: 3 & 6 months. Range of wrist movement, pain, function [modified Gartland and Werley], hand function for activities of daily living [modified Jabsen test]
(3) Clinical:
Complications: deformity


NotesAbstract only.
Severe lost to follow up
Letter sent to trialist on 20 December 2001.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Jackson 2002

MethodsMethod of randomisation: not stated
Assessor blinding: yes for radiological outcomes
Intention to treat: not known
Lost to follow up: not known


ParticipantsFour hospitals, Canada
101 participants
Inclusion criteria: Acute displaced extra-articular distal radius fractures, age > 18 years, intention to treat non-operatively.
Exclusion criteria: failed closed reduction.
Classification: AO 3.1 and 3.2; extra-articular
Sex: not stated
Age: not stated
Assigned: 30/31/40 [modified sugar-tong splint / volar-dorsal splint / cylindrical POP]
Assessed: Assessed: 30/31/40 (at 1 or 4 weeks?)


InterventionsTiming of intervention: not stated. Closed reduction.
(1) Muenster modified sugar-tong fibreglass splint
(2) Volar-dorsal fibreglass splint
(3) Cylindrical POP
No information on length of immobilisation or aftercare.


OutcomesLength of follow up: 6 months; also 7 and 28 days and 2 months
(1) Anatomical: X-ray pre and post manipulation and 1 and 4 weeks
(2) Functional: at 2 and 6 months (no results)
(3) Clinical:
Complications: not detailed


NotesAbstracts only.
No further information forthcoming from trialists. Requests sent to different authors: 8 November 2002, 2 February 2004 and 20 June 2005.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Jensen 1997

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: no - post randomisation exclusions including 7 who did not fulfil inclusion criteria
Lost to follow up: 14 (23%)


ParticipantsTeaching hospital, Denmark
62 participants
Inclusion criteria: minimally displaced or undisplaced Colles' fracture Older I or IIa, dorsal angulation < 5 degrees with no radial shortening or angulation 5+ degrees with up to 2.0 mm radial shortening
Exclusion criteria: previous fractures of either wrist
Classification: Older - modified (I & IIa)
Sex: 32 female (of 48)
Age: mean 57 years, range 19-86 years (of 48)
Assigned: ?/? [1 week / 3 weeks]
Assessed: 22/26


InterventionsTiming of intervention: after admission to A&E department, written consent required for study inclusion.
(1) Dorsal plaster cast for 1 week. Motion within range of comfort after cast removal
(2) Dorsal plaster cast 3 weeks


OutcomesLength of follow up: 6 months; also at cast removal and 12 weeks.
(1) Anatomical: X-ray at cast removal and 6 months. Angulation and axial radial shortening.
(2) Functional: cast removal, 12 weeks and 6 months. Deformity, pain, range of wrist movement, grip strength, (also complications), in functional score [modified Gartland and Werley]. Time off work.
(3) Clinical: times as above.
Complications: within functional score.


Notes


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Kelly 1997

MethodsRandomisation by pre-numbered envelopes
Assessor blinding: not reported
Intention to treat: likely
Lost to follow up: none


ParticipantsTeaching hospital, UK
30 participants
Inclusion criteria: moderately displaced Colles' fracture, 10 - 30 degrees of dorsal angulation, < 5 mm radial shortening.
Exclusion criteria: < 65 years, previous ipsilateral forearm fractures
Classification: Frykman (1&2, 3&4, 5&6, 7&8); extra- and intra-articular
Sex: 27 female
Age: mean 75 years
Assigned: 15/15 [Manipulation / Control]
Assessed: 15/15


InterventionsTiming of intervention: not stated.
(1) Bier’s block manipulation and immobilisation in forearm plaster. Removed at 5 weeks.
(2) Immobilisation in forearm plaster. Removed at 5 weeks.
All patients assessed for physiotherapy.


OutcomesLength of follow up: 3 months; also 1, 3 and 5 weeks, and 1 month.
(1) Anatomical: X-ray at admission, post reduction and 5 weeks. Radial and dorsal angulation, radial shortening.
(2) Functional: Combined score of subjective and objective outcomes [modified Gartland and Werley]. Grip strength, pain, stiffness.
(3) Clinical: swelling, vasomotor changes, cosmetic deformity, dolorimetry ratio.
Complications:
Redisplacement/displacement: 2/2 [Manipulation / Control]
Rereduction or secondary reduction: 0/0
Algodystrophy (RSD): 1/1
Finger stiffness: 3/3


NotesStresses selection of elderly patients.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Kongsholm 1981

MethodsMethod of randomisation: not stated
Assessor blinding: not known
Intention to treat: not known
Lost to follow up: not known


ParticipantsTeaching hospital, Sweden
106 participants
Inclusion criteria: Colles' fracture [not defined]
Exclusion criteria: not stated
Classification: not stated
Sex: not stated
Age: not stated
Assigned: ?/?/? [3 groups]
Assessed: ?/?/?


InterventionsTiming of intervention: not known, but acute fractures.
Duration of treatment not known.
(1) Manual reduction under local anaesthesia then dorsal plaster splint
(2) Manual reduction under local anaesthesia then circular plaster cast
(3) Mechanically applied continuous traction without anaesthesia then circular plaster cast


OutcomesLength of follow up: 6 months
(1) Anatomical: overall, Lidstrom?
(2) Functional: overall, Lidstrom?
(3) Clinical: pain during reduction (not for this review)
Complications:
Recurrent fracture dislocations: 27% group (1) / 10% groups (2) and (3)


NotesAbstract only No discrete data


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Ledingham 1991

MethodsMethod of randomisation: not stated
Assessor blinding: blind functional assessment
Intention to treat: probable but 3 participants removed from trial before treatment completion
Lost to follow up: 10 (17%) [6 months]


ParticipantsTeaching hospital, UK
60 participants
Inclusion criteria: closed displaced distal radial fracture requiring MUA [not defined]
Exclusion criteria: < 18 years, bilateral fractures, previous history of distal radial fracture or inability to follow instructions
Classification: Frykman
Sex: 50 females
Age: mean 60.5 years [3 point brace / POP]
Assigned: 30/30 [3 point brace / POP]
Assessed: 24/26 [6 months]


InterventionsTiming of intervention: not stated.
All reduction performed under general analgesia.
(1) Closed MUA and a molded functional POP applied with 3 point loading in neutral position. Brace allowed free movement at radiocarpal joint - pronation and supination restricted. Removed 5-6 weeks.
(2) Closed MUA and POP dorso-radial slab with wrist in ulnar deviation and slight palmar flexion. POP completed 1-2 weeks later. Plaster removed 5-6 weeks.


OutcomesLength of follow up: 6 months; also at 1 day post MUA, 7-14 days, 35-42 days and 12 weeks
(1) Anatomical: X-ray pre and post manipulation and 7-14 days, 5 to 7 weeks. Combined score: radial length and angle, dorsal angulation (Van der Linden).
(2) Functional: Combined score: subjective complaints, ROM, Grip strength, complications [Stewart method based on Gartland and Werley]
(3) Clinical:
Complications :
Remanipulation: 0/2 [3 point brace / POP]
Median nerve symptoms (CTS): 14.5% at 6 months for whole study group
Radial nerve neuropraxia: 6/0 - all resolved
EPL rupture: 0/1
Sudeck's atrophy: 0/0
Shoulder-hand syndrome: 0/0


NotesInitial and post-MUA displacements not presented.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

McAuliffe 1987

MethodsRandomisation by alternation (quasi-RCT)
Assessor blinding: not known, but independent assessor of function and pain
Intention to treat: not known
Lost to follow up: 28 (26%) [1 year]


ParticipantsTeaching hospital, UK
108 participants
Inclusion criteria: all women > 60 years with closed Colles' fracture [not defined]
Exclusion criteria: not stated
Classification: Lidstrom (I,IIA-E); extra-articular and intra-articular
Sex: all female
Age: mean 72/73 years
Assigned: 54/54 (3 weeks POP / 5 weeks)
Assessed: 41/39 (1 year)


InterventionsTiming of intervention: not stated but all reduction in casualty department.
Closed MUA and POP dorso-radial slab. POP completed 24 hours later. Radiograph at 1 week and remanipulation if required.
(1) Immobilisation continued for '3 weeks' (19-22 days)
(2) Immobilisation continued for '5 weeks' (34-45 days)


OutcomesLength of follow up: 1 year; also at 1 day post MUA, 1 week and 3 months
(1) Anatomical: X-ray pre and post manipulation, 1 week, 3 months and 1 year. Radial shortening, radial deviation and dorsal angulation, overall result [modified Lidstrom]
(2) Functional: 3 months, 1 year. Range of wrist movement, grip strength, pain. Combined score grading [Gartland & Werley]. Subjective assessment.
(3) Clinical:
Complications: no data presented


NotesBaseline data not given but may be the same as those at 3 months. Groups not matched for degree of displacement or adequacy of initial reduction.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

McMillan 1996

MethodsMethod of randomisation: not stated
Assessor blinding: not known
Intention to treat: not known
Loss to follow up: not known


ParticipantsHospital, UK
80 participants
Inclusion criteria: displaced Colles' fracture, age over 50 years
Exclusion criteria: symptoms of median nerve compression
Classification: not stated
Sex: not stated
Age: not stated
Assigned: ?/?
Assessed: ?/?


InterventionsTiming of intervention: on presentation to Orthopaedic department.
(1) Delayed primary manipulation under regional anaesthesia at 1 week after back slab in displaced position
(2) Immediate primary manipulation
Probably plaster cast was applied after MUA in both groups


OutcomesLength of follow up: not stated
(1) Anatomical: radiological outcomes measured
(2) Functional: discomfort only
(3) Clinical:
Complications:
Median nerve compression: 0/? (1 week)


NotesAbstract only
Mr James, last contacted in August 2000, indicated that he would be contacting Mr Kinninmonth to discuss the trial report and whether to send it on for this review. He seemed to be intending to write up the trial for publication.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Millett 1995

MethodsRandomisation by use of randomisation sheet [information from author]
Assessor blinding: blind and independent assessment of radiographs
Intention to treat: not known
Lost to follow up: 7 (7%); and 10 deaths


ParticipantsTeaching Hospital, UK
90 participants
Inclusion criteria: closed Colles' fracture [not defined] all grades. Normal hand/arm function before injury, females only, normal contralateral forearm and hand.
Exclusion criteria: bilateral fractures, previous history of forearm/hand injury, inability to return for follow up, generalised rheumatic disease.
Classification: Frykman (I to VIII); extra- and intra-articular
Sex: all females
Age: mean 61/60 years; range 22-88 years
Assigned: 45/45 [Viscopaste / POP]
Assessed: ?/?


InterventionsTiming of intervention: not stated.
Displaced fractures (definition?) manipulated under general or local anaesthesia.
(1) Below-elbow POP with wrist in ulnar deviation and supination for 3 weeks, then flexible Viscopaste allowing early joint mobilisation for 2 weeks
(2) Below-elbow POP with wrist in ulnar deviation and supination for 5 weeks


OutcomesLength of follow up: 3 years; also at 1 day post MUA, 3 ,5, 12 and 26 weeks post MUA.
(1) Anatomical: X-ray pre and post manipulation and 1, 3, 5 weeks, 3 and 6 months and 3 years. Radial tilt, radio-ulnar space, dorsal tilt, radial shortening.
(2) Functional: at 3 and 5 weeks, 3 and 6 months and 3 years. Range of wrist movement, grip and pinch strength, finger movement, hand swelling and pain. Subjective assessment.
(3) Clinical:
Cosmetic appearance: 1/3 of participants in both groups had residual deformity. Patient comfort.
Complications: overall rate (not defined), osteoarthritis.
Remanipulation of reduced fractures: 1/4 [Viscopaste / POP] - but no information on numbers reduced.


NotesDifference in numbers lost to follow up in paper and numbers assessed provided by authors.
Five participants of each group had died by 3 years.
Outliers excluded from analyses of radiological and functional outcomes.
The formulation of Viscopaste was altered by the manufacturers after this experiment.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Moir 1995

MethodsRandomisation by computer generated randomisation sheet
Assessor blinding: yes (functional outcomes)
Intention to treat: not known
Lost to follow up: 6 (7%)


ParticipantsTeaching hospital, UK
85 participants
Inclusion criteria: closed displaced distal radial fracture requiring MUA [not defined], fused epiphysis
Exclusion criteria: < 18 years, bilateral fractures, previous distal radial fracture or inability to follow instructions
Classification: Frykman (I-VIII probably); extra- and intra-articular
Sex: 70 females (out of 79)
Age: median 55 / 60 years [3 point brace / POP]; range 21-86 years
Assigned: 49/36 [3 point brace / POP]
Assessed: 44/35


InterventionsTiming of intervention: not stated.
Reduction performed under general or regional anaesthesia.
(1) Closed MUA and a 2 part brace applying 3 point loading. Brace removed 5-6 weeks
(2) Closed MUA and POP dorso-radial slab with wrist in ulnar deviation and slight palmar flexion. POP completed 10-14 days later. Cast removed 5-6 weeks


OutcomesLength of follow up: 6 months. Also at 1 day post MUA, 10-14 days, 5-6 weeks, 8 and 13 weeks post MUA.
(1) Anatomical: X-ray pre and post manipulation and 10-14 days, 5-6 weeks. Radial length, radial angle and dorsal angulation. Overall [modified Lidstrom and Sarmiento demerit scoring system]
(2) Functional: at 8, 13 and 26 weeks. Range of wrist movement, grip and pinch strength, finger movement, hand swelling and pain. Combined score grades: subjective, objective e.g. ROM outcomes and complications [modified Gartland and Werley]
(3) Clinical:
Complications:
Equipment failure (brace discomfort): 3 (excluded participants)/0 [3 point brace / POP]
Incorrect application of treatment: 1(excluded patient)/0
Surgical correction: 1/1 (excluded participants)
Remanipulation: 4/2
Carpal tunnel syndrome: 8/5
Radial nerve neuropraxia: 3/0
Ulnar nerve compression: 1/3
RSD: 2/3
Hand swelling: 11/14
Poor finger movement: 4/11


NotesGroups not comparable for initial displacement - brace group were initially less severely displaced than POP group, nor intra-articular fractures - brace group: 2/3rd, POP group: 1/2th.
Abstracts reported interim data.
Comments on trial from Moiz 1996 questioning some of the conclusions and querying about costs.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Nielsen 1981

MethodsRandomisation by odd and even dates (quasi-RCT)
Assessor blinding: not reported
Intention to treat: not known
Lost to follow up: not known, probably none


ParticipantsTeaching hospital, Denmark
55 people with Colles' fracture
Inclusion criteria: Colles' fracture, also malleolar fracture and finger joint injuries
Exclusion criteria: age < 15 years
Classification: not stated
Sex: not stated
Age: not stated
Assigned: 32/23 [Hexelite / POP]
Assessed: 32/23


InterventionsTiming of intervention: 1 week post trauma after swelling had diminished.
(1) Hexelite (R) - thermoplastic polyester bandage
(2) POP forearm dorsal splint
Duration not given, but similar


OutcomesLength of follow up: not stated, until cast removed?
(1) Anatomical: none given
(2) Functional: patient's opinion of hand function during cast wear
(3) Clinical: pain during cast wear
Complications: (during cast immobilisation)
Poor hand function: 4/1 [Hexelite / POP]
Poor stabilisation: 4/4
Pain: 1/3
Bandage repair: 3/3
Skin pressure: 7/6
Skin damage: 4/1
Inconvenience - water intolerant: 16/21
(4) Resource use: costs of bandage


NotesStudy also enrolled 46 people with ankle fractures and 82 requiring finger bandages


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

O'Connor 2002

MethodsRandomisation by odd and even dates of injury (quasi-RCT)
Assessor blinding: yes, blinded functional assessment by physiotherapist.
Intention to treat: marginal - data for 10 participants not given in baseline characteristics but numbers randomised obtained
Lost to follow up: 7 (+3 requiring further treatment: 2 manipulations and 1 refracture) (13%)


ParticipantsTeaching hospital, Ireland
76 participants
Inclusion criteria: minimally displaced closed Colles' fracture, not requiring manipulation, isolated upper limb injury
Exclusion criteria: previous wrist fracture, impaired cognitive function
Classification: Universal (all type 1: extra-articular, undisplaced)
Sex: 44 females (of 66)
Age: mean 57 years, range 16-81 years (of 66)
Assigned: 37/39 [Splint / POP]
Assessed: 34/32


InterventionsTiming of intervention: at first fracture clinic appointment.
(1) 'Futuro' wrist splint (lightweight and removable) fitted by plaster room technician. Participants were instructed to avoid removing splint for 2 weeks other than to tighten it to adjust as swelling diminished. Then to wear it for a further 4 weeks, only removing it for limited periods for personal hygiene / washing.
(2) Below-elbow POP for 6 weeks.
All participants received the same mobilisation instructions and post-immobilisation physiotherapy.


OutcomesLength of follow up: 12 weeks; also 1, 2 and 6 weeks.
(1) Anatomical: X-ray at presentation, 1, 2 and 6 weeks. Scoring system for displacement (dorsal angulation, radial shortening, radial angulation) [modified Lidstrom]: no results given
(2) Functional: pain, patient problems and satisfaction during splint/cast wear. At 6 and 12 weeks: range of wrist movement, grip strength. Combined functional score [Stewart modification of Gartland & Werley]. Subjective assessment via functional questionnaire.
(3) Clinical:
Complications:
Displacement requiring manipulation: 1/1 [Splint / POP]
Refracture: 0/1
Change of splint/cast: 0/14
Median nerve compression: 1/2
Ulnar nerve compression: 0/2 (1 persisted at 12 weeks)
Sudek's atrophy: 1/1 (resolved by 12 weeks)
(4) Resource use: costs, not quantified


NotesLead trialist provided a copy of the uncorrected proofs of article, pending publication in J Hand Surg Br 2003: published report listed in references in updated review (Issue 2, 2004)

Further information from Damian O'Connor received on 14/11/02 regarding numbers randomised, fracture type and care programme.

Abstract (Mullett 2002) involved 71 patients. There were other slight differences, including exclusion criterion: age < 20 years, which clearly didn't apply.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Rosetzsky 1982

MethodsRandomisation by closed envelopes, according to predetermined randomisation list
Assessor blinding: not reported
Intention to treat: no, 4 exclusions
Lost to follow up: 1 (2%)


ParticipantsTeaching hospital, Denmark
50 participants
Inclusion criteria: fresh fracture of lower radius and an ulnar avulsion (Colles'). None were open. Displaced and undisplaced.
Exclusion criteria: none given
Classification: none used
Sex: 35 female
Age: mean 45 years, range 13-90 years
Assigned: 25/25 [Polyurethane / POP]
Assessed: 24/22


InterventionsTiming of intervention: not known.
Displaced fractures (dorsal angulation >15 degrees) reduced.
(1) Below-elbow polyurethane cast/brace with zipper. Displaced fractures reduced after cast application, whilst cast set.
(2) Below-elbow POP cylinder. Displaced fractures reduced before cast application.
All casts removed after 6 weeks.


OutcomesLength of follow up: 6 weeks
(1) Anatomical: X-ray at admission and after 6 weeks. Difference in radiological position.
(2) Functional: pain and restricted motion of free joints as reasons for cast adjustment.
(3) Clinical:
Complications:
Secondary adjustment of cast: 8/8 [Polyurethane / POP]
Fracture displacement: 1/5
Secondary reduction: 0/0
Patient inconvenience: 6/4
Skin damage: 0/0


Notes


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Ross 1984

MethodsMethod of randomisation: unknown but a quasi-randomised method was used
Assessor blinding: not known
Intention to treat: not known
Lost to follow up: not known


ParticipantsTeaching hospital, UK
405 participants
Inclusion criteria: Colles' fracture [not defined]
Exclusion criteria: not stated
Classification: Own: Type I [extra-articular]; Type II [intra-articular]
Sex: not stated
Age: no details but significant differences between groups noted
Assigned: 121/284 [brace / POP]
Assessed: ?/?


InterventionsTiming of intervention: not known.
Duration of treatment not known.
(1) Orthoplast functional brace, forearm in supination
(2) Below-elbow POP


OutcomesLength of follow up: 3-4 months
(1) Anatomical: radial length, radial deviation and volar tilt
(2) Functional: range of wrist movement, grip strength, disability and pain
(3) Clinical: cosmetic appearance (prominence of ulnar styloid).
Complications: nerve


NotesAbstract only.
No discrete data.
On contact in August 2000, Mr Ross reported that the trial was quasi-randomised, that there were no other publications of the trial and that the trial materials had unfortunately been discarded.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Sarmiento 1980

MethodsRandomisation based on date of fracture (quasi-RCT)
Assessor blinding: not reported
Intention to treat: not known
Lost to follow up: 50 (32%)


ParticipantsTeaching hospital, USA
154 people with 156 distal radius fractures; 93 displaced fractures.
Inclusion criteria: not clarified
Exclusion criteria: not stated
Classification: Sarmiento (I-IV); extra- and intra-articular
Sex: 106 females
Age: mean 49 years; range 15-92 years
Assigned: 156 (?/?)
Assessed: 104 (?/?); subgroup of displaced fractures: 38/33 [Pronation/Supination]


InterventionsTiming of intervention: not stated.
Most reduction performed under regional anaesthesia; some local.
(1) Closed MUA and above-elbow POP with wrist in 20 degrees of volar and ulnar deviation with the forearm in pronation. About 1 week later, Orthoplast brace applied in pronation.
(2) Closed MUA and above-elbow POP with wrist in 20 degrees of volar and ulnar deviation with the forearm in supination. About 1 week later, Orthoplast brace applied in supination.
Cast immobilisation generally between 8-9 days; brace 2-5 weeks.


OutcomesLength of follow up: 4 to 60 weeks; mean 15 weeks
(1) Anatomical: X-ray at pre and post MUA, on removal of POP, on application of brace and at final assessment. Scored using modified Lidstrom. Volar tilt, radial length and deviation
(2) Functional: Grip strength, range of wrist movement, loss of pronation, hand function, elbow motion. Overall score [Gartland and Werley]
(3) Clinical: Complications:
RSD: 1 overall
Carpal tunnel syndrome: 3 in all (mild)
Ulnar nerve injury: 1 in all (resolved)


NotesBaseline data not given by treatment group.
No discrete data presented.
Mixture of un/displaced or extra/intra articular fractures.
Wide range in period of immobilisation/treatment: average time of initial cast application varied according to fracture type.
Data only presented for displaced fracture groups.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Sorensen 1986

MethodsRandomisation by sealed envelopes
Assessor blinding: not known
Intention to treat: some problems, 7 exclusions from baseline
Loss to follow up: 7 (7%)?


ParticipantsHospital, Denmark
100 participants
Inclusion criteria: displaced fractures of the distal 5 cm of radius +/- fracture of ulnar styloid
Exclusion criteria: previous fracture, bilateral fracture, other ipsilateral limb injury, open epiphysis or refracture.
Classification: Van der Linden Type I-IV; extra-articular and intra-articular
Sex: 82 females (of 93)
Age: not stated
Assigned: ?/? [above-elbow POP/ below-elbow POP]
Assessed: 33/60


InterventionsTiming of intervention: not given.
All reductions under local anaesthetic.
Duration of treatment: not stated
(1) Closed manipulation & above-elbow full POP, arm in pronation
(2) Closed manipulation & below-elbow dorsal slab, arm in pronation


OutcomesLength of follow up: 6 months; also at 1, 2, 6, 7 and 12 weeks post MUA.
(1) Anatomical: dorsal angulation and axial compression at post-reduction, 1 and 6 weeks [Bunger, Lidstrom]
(2) Functional: 1, 2, 6, 7 and 12 weeks and 6 months: Range of movement, combined score grades [Gartland & Werley]
(3) Clinical:
Complications:
Sympathetic reflex dystrophy: 1/1 [above-elbow / below-elbow]
Symptoms of nerve compression: 8/11
Prolonged healing time: 0/2
Replastering: 5/7


NotesDanish paper: brief translation obtained.
Mixed intra/extra articular fractures.
Imbalance in numbers at allocation referred to but not fully explained.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Stewart 1984

MethodsRandomisation based on date of birth (quasi-RCT)
Assessor blinding: yes for functional assessment
Intention to treat: problems - 8 excluded before treatment completed
Loss to follow up (6 months): 34 (14%)


ParticipantsDistrict General Hospital, UK
243 participants
Inclusion criteria: patients with displaced Colles' fracture [not defined but included minimally displaced fractures]
Exclusion criteria: not stated
Classification: not stated; extra- and intra-articular fractures
Sex: 207 female
Age: mean 60 years; range 18-86 years
Assigned: 70/72/93 [supination / short brace / POP]
Assessed: 64/67/84 [3 months]; 59/67/83 [6 months]


InterventionsTiming of intervention: within 10 days of injury
Duration of treatment: 6 weeks.
Majority (193 = 79%) of fractures were reduced, mainly under IVRA. Below-elbow back slab applied for 9-10 days. All splintage removed at 6 weeks.
(1) Above-elbow cast bracing in supination
(2) Below-elbow cast brace
(3) Standard forearm POP


OutcomesLength of follow up: 6 months; also assessed at times shown below.
(1) Anatomical: X-ray at presentation, post reduction, 10 days and 6 weeks. Radial angle and length, dorsal angle. Graded modified Sarmiento criteria based on Lidstrom.
(2) Functional: at 3 and 6 months. Combined score grades - subjective, objective including ROM, complications [Gartland and adapted Sarmiento]
(3) Clinical:
Complications:
Carpal tunnel compression: 18/19 [supination & short brace / POP] (3 months); 26 overall (6 months)
Radial nerve injury: 11 in "braced groups" (3 months); 1 at 6 months
Attending physiotherapy for excessive finger / shoulder stiffness after 6 weeks: 70 in all
EPL rupture: 1 in all
Dupuytren's disease: 23 overall (6 months)
Sudeck's osteodystrophy: none
Shoulder stiffness: none
Secondary surgery: 3 (Baldwin's operation) + 9 nerve decompressions overall
Trigger finger: 3 overall (3 months); 1 (6 months)
Ulnar nerve compression: 2 overall (3 months); 1 (6 months)
(4) Resource use:
Equipment problems: 38 visits/142 for both braced groups; 3 participants/93 POP group. Included: Serious sweat rashes: 2 in brace groups (braces removed)


NotesEleven fractures were remanipulated before allocation.
Ratio of intra-articular fracture not identical between groups (reported as not statistically significant).
New data on complications reported in further report included in the second update.
Fractures with "less than 10 degrees of dorsal angulation and scarcely any shortening or radial angulation" were not reduced.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?NoC - Inadequate

Stoffelen 1998

MethodsMethod of randomisation: not stated
Assessor blinding: unlikely, not reported
Intention to treat: not stated, potential problems - see notes
Loss to follow up: not known


ParticipantsTeaching hospital, Belgium
52 participants
Inclusion criteria: minimally displaced, stable distal radius fracture. No dorsal comminution.
Exclusion criteria: dorsal angulation > 10 degrees, radial shortening > 2 mm, radial shift > 2 mm
Classification: Frykman (no data)
Sex: male and female
Age: not stated
Assigned: 25/27 [1 week / 3 weeks]
Assessed: ?/? (25/27 assumed)


InterventionsTiming of intervention: not stated.
(1) Below-elbow cast with wrist in neutral position for 1 week
(2) Same for 3 weeks
A removable Valpeau dressing was applied after plaster removal in some cases.


OutcomesLength of follow up: 1 year; also assessed at 6 weeks, and 3 and 6 months.
(1) Anatomical: no information
(2) Functional: pain (VAS: 0-10) at plaster removal. Overall grading (Cooney score). Grip strength.
(3) Clinical: patient satisfaction
Complications:
Continuation of plaster immobilisation 0/0 [1 week / 3 weeks]
Use of Velpeau dressing: no data
Reflex sympathetic dystrophy: 1/3 (transient); 0/2 (unresolved)


NotesReference (no. 9 in paper) to the Cooney scoring system was incorrect.

Original attention was to treat the 1 week group with removable splints but inhibiting pain prompted a change to 1 week of plaster. It is not clear if these patients were initially part of the trial and thence excluded, and whether those in the 3 weeks group who were randomised at the same time were included or excluded.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Tumia 2003

MethodsRandomisation by telephone using computer generated randomisation scheme; stratified by severity of fracture (minimally displaced; displaced)
Assessor blinding: blind assessment of function at 8, 12 & 24 weeks
Intention to treat: likely, but case notes lost for 10 people
Lost to follow up: probably none but 10 excluded (3%)


ParticipantsTeaching hospitals: 5 trauma centres based in 3 countries: Sweden, The Netherlands and UK
339 participants
Inclusion criteria: unilateral Colles' fracture. Minimally displaced and displaced fractures. Fused epiphysis.
Exclusion criteria: age < 18 years, previous forearm fracture
Classification: Frykman (intra- and extra-articular).
Sex: 271 female
Age: mean 59 years, range 18-98 years
Assigned: 169/170 [brace / POP]
Assessed: 166/163


InterventionsTiming for intervention: not stated
Reduction for 188 displaced fractures.
(1) Aberdeen Colles-fracture brace: a 2 part plastic brace applying 3 point loading; parts connected by 2 elasticated Velcro strips. Allows wrist movement. Brace removed 5-6 weeks
(2) POP dorso-radial slab completed 10-14 days later to Colles-type cast. Cast removed 5-6 weeks


OutcomesLength of follow up: 24 weeks; also 10 days, and 7, 8 and 12 weeks.
(1) Anatomical: X-ray at 0, 10 and 35 days. Overall score based on dorsal angulation, radial shortening and radial angulation [Bunger].
(2) Functional: 5, 8, 12 & 24 weeks. Pain, grip strength, overall functional scores [modified Gartland & Werley]
(3) Clinical: complications in functional score


NotesLead trialist provided a pre-publication draft of the paper and further details of method of randomisation.

Request for further information sent 13/11/02.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?YesA - Adequate

Van der Linden 1981

MethodsMethod of randomisation: not clear, “random order operations design”
Assessor blinding: not reported
Intention to treat: unlikely, subgroup analysis only - no denominators
Lost to follow up: not reported


ParticipantsTeaching hospital, Sweden
250 participants
Inclusion criteria: undisplaced and displaced Colles' fracture
Exclusion criteria: not stated
Classification: not stated
Sex: 211 female
Age: range 16-92 years
Assigned: ?/?/?/?/? [5 groups]
Assessed: ?/?/?/?/?


InterventionsTiming of intervention: not stated
Reduction under local anaesthesia except in 48 undisplaced fractures. All below-elbow plaster immobilisation.
Duration of treatment: 10 days + 4 weeks.
(1) Circular plaster cast, hand in palmar flexion and pronation, with ulnar deviation (Cotton-Loder position). Replaced after 10 days by dorsal splint, hand neutral, ulnar deviation preserved.
(2) Dorsal splint, hand neutral, ulnar deviation preserved.
(3) Circular plaster cast, hand neutral, ulnar deviation preserved.
(4) Dorsal splint, hand neutral, without ulnar deviation.
(5) Circular plaster cast, hand neutral, without ulnar deviation.


OutcomesLength of follow up: 8 months; also 10 days, POP removal (+4 weeks), and +4 weeks.
(1) Anatomical: X-ray at all follow-up times. Dorsal angulation, radial shift.
(2) Functional: Pain, grip strength, range of movement.
(3) Clinical: swelling, cosmetic results. Complications:
Redisplacement
Rereduction: 16 in all


NotesBaseline and follow-up denominators not given. Results (mean values) presented without denominators for the 202 displaced fractures only.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Vang Hansen 1998

MethodsMethod of randomisation: not stated
Assessor blinding: not reported
Intention to treat: not known, but exclusions (see notes)
Lost to follow up: 27 (27%)


ParticipantsRegional hospital, Denmark
100 participants
Inclusion criteria: Colles' fracture, Older type 1 and 2, age 18+ years
Exclusion criteria: hemiplegia, pathological fracture, senile dementia, outside hospital area, unwilling to join
Classification: Older (1 & 2)
Sex: 57 female (of 73)
Age: mean 60/61 years (range 18-96 years) (of 73)
Assigned: ?/? [3 weeks POP/ 5 weeks]
Assessed: 37/37 (fractures; 1 year)


InterventionsTiming of intervention: not stated.
If not reduced, wrist immobilised in neutral position. Where reduced (no definition), MUA with local anaesthesia, wrist immobilised with hand in slight pronation, flexion and ulna deviation.
(1) Below-elbow dorsal POP immobilisation for 3 weeks
(2) Below-elbow dorsal POP immobilisation for 5 weeks


OutcomesLength of follow up: 1 year; also at 10 days and at end of immobilisation, and 3 days after that.
(1) Anatomical: X-ray at 10 days, 3-5 weeks, 3-5 weeks + 3 days, 1 year. Appearance, dislocation.
(2) Functional: at 1 year. Pain, range of movement, grip score
(3) Clinical:
Complications:
Dislocation: 6 in all
Tendon rupture: 1/1 [3 weeks POP/ 5 weeks]


NotesSix type 2 fractures excluded from study as they dislocated within 10 days - all had K-wire fixation after remanipulation.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Wahlstrom 1982

MethodsMethod of randomisation: not stated
Assessor blinding: not known
Intention to treat: not known
Loss to follow up: not stated (probably none)


ParticipantsRegional hospital, Sweden
42 participants
Inclusion criteria: people with closed displaced extra-articular Colles' fracture, females > 40 years
Exclusion criteria: not above
Classification: Lidstrom group II a+c
Sex: all female
Age: mean 65 years
Assigned: 16/14/12 [supination / pronation / neutral]
Assessed: 16/14/12


InterventionsTiming of intervention: not stated.
All fractures reduced under haematoma block.
Duration of treatment: not stated.
Forearm (up to MCP joints) POP with forearm in:
(1) Supination
(2) Pronation
(3) Neutral (mid-way)


OutcomesLength of follow up: 5 weeks
(1) Anatomical: X-ray timing injury, post reduction, 10 days, 4-5 weeks. Dorsal angle. Redislocation.
(2) Functional: not given
(3) Clinical:
Complications:
Redisplacement: 8/2/6 [supination / pronation / neutral]
Rereduction: 3/1/1


NotesResults only given for 5-weeks follow up.


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

Wilson 1984

MethodsMethod of randomisation: not stated
Assessor blinding: not known
Intention to treat: likely
Loss to follow up: none


ParticipantsTeaching hospital, UK
41 participants
Inclusion criteria: people with displaced Colles' fracture [not defined], simple and comminuted, requiring manipulation.
Exclusion criteria: too frail, bilateral fractures or multiple injuries
Classification: not stated
Sex: not stated
Age: not stated
Assigned: 21/20 [supination / pronation]
Assessed: 21/20 [3 months]


InterventionsTiming of intervention: on day of attendance.
Duration of treatment: 4 weeks.
All fractures reduced under regional block by non-specialist junior staff.
(1) Above-elbow POP slab, completed at 24 hours, with forearm in supination. Cut down at 2 weeks to forearm.
(2) Standard forearm POP slab, completed at 24 hours, in pronation

All wrists held in volar flexion and ulnar deviation


OutcomesLength of follow up: 12 weeks
(1) Anatomical: X-ray at presentation, post reduction 1, 2 [above-elbow group] and 4 weeks. Radial deviation and volar tilt [Gartland & Werley]
(2) Functional: Frykman criteria assessment (strength, motion, pain) at 11-12 weeks post-injury
(3) Clinical:
Complications: mention of finger stiffness in group (1)


NotesShort follow up


Risk of bias

ItemAuthors' judgementDescription

Allocation concealment?UnclearB - Unclear

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Davison 2001Children only. Conservative treatment for torus fractures.

Earnshaw 1999Not in scope of review: reduction technique trial.

Harris 2002Randomised trial investigated early mobilisation in people with unilateral Colles' fracture. Four treatment groups: Stable fractures - no manipulation: 1 week versus 5 weeks plaster cast; unstable fractures - manipulation: 2-3 weeks versus 6 weeks plaster cast. Trial was stopped after recruiting 20 patients. Main investigator (Dr T Harris) left post. Information provided by co-investigator, Dr James Metcalfe. No analysis or publication planned.

Hearne 2003Trial aimed to compare early mobilisation (wrist splint as required and standard physiotherapy) after 10-14 days plaster cast immobilisation versus 4 weeks plaster cast immobilisation in people with stable distal radius fractures with no other relevant or significant pathology, aged 50+ years.

This was aborted with no recruited patients due to difficulties in obtaining a satisfactory definition of a stable fracture and lack of patient consent.

Kongsholm 1987Not in scope of review: anaesthesia and reduction technique trial.

Kowalski 2002Trial compared fibreglass versus plaster of Paris casts in fractures of the arm and leg but did not split by fracture type. No response was received from lead trialist to a request for separate fracture information sent 31/10/2002.

McGeoy 1986Unlikely to be a randomised comparison. Only available as a conference abstract.

Milliez 1992Randomised trial evaluating the duration of post-surgical immobilisation. Now included in our review of surgical treatment.

Moran 2002Randomised trial indicated as having started 01/12/2000 is currently postponed until funding obtained. Message from Mr Moran's secretary on 6 August 2002.

Pool 1973Though sometimes stated to be a randomised trial, allocation into four groups was not random or concurrent: the first 50 patients were placed into Group 1, the next into Group 2 and so on.

Shah 2002Described in two abstracts as a prospective study, where "undisplaced distal radial fractures were divided into two groups": plaster immobilisation versus removable volar splint. There was no indication that this was a randomised trial and no further information was forthcoming.

Shah 2003Non randomised comparison of softcast (combicast) versus plaster of Paris cast in 39 people with distal radial fracture.

Shanker 2000Randomised trial, listed in National Research Register (UK), comparing conservative management versus primary manipulation of minimally displaced Colles' fractures in adults. Trial aborted after recruiting 3 patients. Reason given: "Non runner".

Singhania 2001Trial listed in National Research Register (UK) as a comparison of 3 weeks in plaster cast then "Futura" splint versus conventional treatment (5 to 6 weeks in plaster cast) for patients over 50 years of age with an isolated wrist fracture. Failed to trace Dr A K Singhania, no longer at Hull Royal Infirmary, despite help from Mrs Susan Yu. Study may not have been a randomised trial anyway.

Smith 1999Children only. Trial listed in National Research Register (UK) on the management of torus fractures of distal radius.

 
Characteristics of ongoing studies [ordered by study ID]
 
Comparison 1. Manipulation versus control

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

 1 Functional grading: poor or fair1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Redisplacement or displacement beyond study criteria
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Re-manipulation or secondary manipulation
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.3 Algodystrophy (RSD)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.4 Finger stiffness
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Cosmetic deformity1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Cosmetic deformity (subjective)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 Cosmetic deformity (objective)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 2. No immobilisation versus immobilisation

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

 1 Anatomical grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Functional grading2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Not excellent
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Poor or fair
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Pressure sores
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 Problems with bandage / cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.3 Median nerve compression (CTS)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 3. Cast position: supination versus pronation

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

 1 Anatomical displacement2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Mean loss of volar tilt (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.2 Mean loss of radial deviation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.3 Mean loss of dorsal angulation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 2 Functional grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Redisplacement (10+ degrees)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 Rereduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 4. Cast position: neutral (mid-way) versus pronation

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

 1 Anatomical displacement1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Mean loss of dorsal angulation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 2 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Redisplacement (10+ degrees)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Rereduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 5. Palmar flexion or neutral versus dorsiflexion

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

 1 Functional grading: not excellent2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Palmar flexion versus dorsiflexion
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Neutral flexion versus dorsiflexion
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Functional grading: poor or fair2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Palmar flexion versus dorsiflexion
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Neutral flexion versus dorsiflexion
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Discomfort (pressure pain) in plaster
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 6. Modified cast restricted mobilisation versus plaster cast immobilisation

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

 1 Anatomical grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Functional grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 7. Modified sugar-tong cast versus below-elbow cast

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

 1 Anatomical displacement1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Dorsal angulation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 2 Unacceptable anatomical result (dorsal tilt > 10 degrees, radial shortening > 5 mm)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Redisplacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 8. Modified sugar-tong fibreglass splint versus cylindrical plaster cast

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

 1 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Redisplacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Rereduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 9. Modified sugar-tong fibreglass splint versus volar-dorsal fibreglass splint

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

 1 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Redisplacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Rereduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 10. Volar-dorsal fibreglass splint versus cylindrical plaster cast

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

 1 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Redisplacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Rereduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 11. Above-elbow versus below-elbow plaster cast

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

 1 Anatomical grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Functional grading: not excellent1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 at 12 weeks
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 at 6 months
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Functional grading: poor or fair1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 at 12 weeks
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 at 6 months
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 4 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Re-application of plaster
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.2 Delayed fracture healing
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.3 Sudeck's atrophy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.4 Nerve compression
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 12. Braced position: supination versus pronation

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

 1 Anatomical displacement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Loss of volar tilt (at least 2 degrees)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Loss of radial length (at least 2 mm)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Anatomical grading: poor or fair1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 3 Functional grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 13. Braced position: supination versus other

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

 1 Anatomical grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Poor finger flexion1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 14. Functional brace versus plaster cast

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

 1 Anatomical displacement (at splintage removal)2Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Dorsal displacement/angulation (degs)
2Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.2 Dorsal shift (mm)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.3 Radial displacement (degs)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.4 Radial shift (mm)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.5 Radial shortening (mm)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 2 Anatomical grading3Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Not excellent
3Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Poor or fair
3Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Range of movement (at splintage removal)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 Extension (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.2 Flexion (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.3 Radial deviation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.4 Ulnar deviation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.5 Pronation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.6 Supination (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 4 Range of movement (at 12 weeks)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    4.1 Extension (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    4.2 Flexion (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    4.3 Radial deviation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    4.4 Ulnar deviation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    4.5 Pronation (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    4.6 Supination (degrees)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 5 Poor finger flexion1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 6 Functional assessment score (0: no problems to 33: maximum)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    6.1 at 6 weeks
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    6.2 at 12 weeks
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 7 Functional grading: not excellent2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    7.1 up to and including 3 months
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    7.2 6 months
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 8 Functional grading: poor or fair2Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    8.1 up to and including 3 months
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    8.2 6 months
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 9 Complications6Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    9.1 Hand swelling during brace or cast use
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.2 Poor finger motion (in brace or cast)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.3 Discomfort necessitating removal (brace or cast)
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.4 Incorrect application of splintage
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.5 Problems with brace or cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.6 Brace or cast change
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.7 Redisplacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.8 Remanipulation, rereduction or manipulation after secondary displacement
5Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.9 Tendon rupture
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.10 Sudeck's atrophy
4Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.11 Upper limb dystrophy (temporary)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.12 Reflex sympathetic dystrophy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.13 Median neuropathy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.14 Median nerve compression (CTS)
3Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.15 Superficial radial nerve paraesthesia
3Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.16 Peripheral radial/ulnar neuropathy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    9.17 Ulnar nerve compression
2Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 10 Assessment of brace or cast use (visual analogue score: 0 to 10)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    10.1 Pain during splintage: 2 weeks (0 = no pain)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    10.2 Pain during splintage: 6 weeks (0 = no pain)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    10.3 Problems with splintage: 2 weeks (0 = no problems)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    10.4 Problems with splintage: 6 weeks (0 = no problems)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    10.5 Satisfaction with splintage: 2 weeks (0 = satisfaction)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    10.6 Satisfaction with splintage: 6 weeks (0 = satisfaction)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 
Comparison 15. Cast material: Polyurethane versus plaster

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

 1 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Redisplacement or secondary displacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Rereduction or secondary reduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.3 Secondary cast adjustment
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.4 Skin damage
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 16. Cast material: Thermoplastic versus plaster

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

 1 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Bandage repair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Poor stability in cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.3 Pain in cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.4 Poor hand function in cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.5 Skin pressure in cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.6 Water intolerant cast (subjective inconvenience)
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.7 Skin damage
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 17. Cast material: Shrinkable polymer (Quickcast) versus fibreglass

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

 1 Anatomical displacement (at cast removal)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    1.1 Change in radial length (mm)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.2 Change in radial inclination (degs)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.3 Change in ulnar variance (mm)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    1.4 Change in volar tiit (degs)
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 2 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Burns or skin irritation from cast application
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Redisplacement or secondary displacement
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.3 Rereduction or secondary reduction
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.4 Early cast change
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.5 Discomfort at thumb base
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.6 Discomfort at cast rim near elbow
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.7 Significant skin problems
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 18. Casting technique: Focused rigidity cast (FRC) versus standard cast

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

 1 Functional impairment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Unable to function during cast wear
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Moderate or severe movement limitations at cast removal
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.3 Moderate or severe loss of power at cast removal
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Very uncomfortable cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Loss of position
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.3 Non-union
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 19. Early mobilisation (3-4 weeks) versus 5-6 weeks plaster immobilisation

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

 1 Pain (mild with stenuous use)1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 2 Patient assessment (pain, disability, mobility): poor or fair1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 at 3 months
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 at 1 year
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Grip strength (% of non-injured hand)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

    3.1 At 3 months
1Mean Difference (IV, Fixed, 95% CI)Not estimable

    3.2 At 6 months
1Mean Difference (IV, Fixed, 95% CI)Not estimable

 4 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Tendon rupture
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Comparison 20. Early mobilisation (1-2 weeks) versus 4-5 weeks immobilisation

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

 1 Mean VAS pain scores (none 0 - 20 cm)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 2 Mean grip strength (mmHg)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 3 Functional grading1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    3.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    3.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 4 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Withdrawal from treatment
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.2 Problems with bandage or cast
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.3 Fracture displaced
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.4 Cosmetic deformity
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.5 Tendon rupture
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.6 Paraesthesia
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.7 Physiotherapy needed
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.8 Shoulder stiffness
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 5 Patient dislike of or non-compliance with treatment1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

 
Comparison 21. Early mobilisation (1 week) versus 3 weeks plaster immobilisation

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

 1 Anatomical displacement1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    1.1 Angulation up to 20 degrees
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    1.2 Axial radial shortening
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 2 Functional grading: not excellent1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    2.1 Not excellent
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    2.2 Poor or fair
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 3 Mean functional score (100 is normal)1Mean Difference (IV, Fixed, 95% CI)Totals not selected

 4 Complications1Risk Ratio (M-H, Fixed, 95% CI)Totals not selected

    4.1 Pain preventing plaster removal
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.2 Further dislocation of fracture
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.3 Initial symptoms of algoneurodystrophy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

    4.4 Persistent algoneurodystrophy
1Risk Ratio (M-H, Fixed, 95% CI)Not estimable

 
Table 1. Some definitions of radiological parameters

ParameterDefinitionNormal value

Dorsal angulation (dorsal or volar or palmar tilt)Angle between a) the line which connects the most distal points of the dorsal and volar cortical rims of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Side view of wrist.Palmar or volar tilt: approximately 11-12 degrees.

Radial lengthDistance between a) a line drawn at the tip of the radial styloid process, perpendicular to the longitudinal axis of the radius and b) a second perpendicular line at the level of the distal articular surface of the ulnar head. Frontal view.Approximately 11-12 mm.

Radial angle or radial inclinationAngle between a) the line drawn from the tip of the radial styloid process to the ulnar corner of the articular surface of the distal end of the radius and b) the line drawn perpendicular to the longitudinal axis of the radius. Frontal view.Approximately 22-23 degrees.

Ulnar varianceVertical distance between a) a line drawn parallel to the proximal surface of the lunate facet of the distal radius and b) a line parallel to the articular surface of the ulnar head.Usually negative variance (e.g. -1 mm) or neutral variance.

 
Table 2. Methodological quality assessment scheme

ItemsScoresNotes

(1) Was the assigned treatment adequately concealed prior to allocation?3 = method did not allow disclosure of assignment.
1 = small but possible chance of disclosure of assignment or unclear.
0 = quasi-randomised, or open list or tables.
Cochrane code (see Handbook): Clearly Yes = A; Not sure = B; Clearly No = C.

(2) Were the outcomes of participants who withdrew described and included in the analysis (intention to treat)?3 = withdrawals well described and accounted for in analysis.
1 = withdrawals described and analysis not possible, or probably no withdrawals.
0 = no mention, inadequate mention, or obvious differences and no adjustment.

(3) Were the outcome assessors blinded to treatment status?3 = effective action taken to blind assessors.
1 = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted.
0 = not mentioned or not possible.

(4) Were important baseline characteristics reported and comparable?3 = good comparability of groups, or confounding adjusted for in analysis.
1 = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data.
0 = large potential for confounding, or not discussed.
Although many characteristics including hand dominance are important, the principal confounders were considered to be age, gender, type of fracture.

(5) Were the trial participants blind to assignment status after allocation?3 = effective action taken to blind participants.
1 = small or moderate chance of unblinding of participants.
0 = not possible, or not mentioned (unless double-blind), or possible but not done.

(6) Were the treatment providers blind to assignment status?3 = effective action taken to blind treatment providers.
1 = small or moderate chance of unblinding of treatment providers.
0 = not possible, or not mentioned (unless double-blind), or possible but not done.

(7) Were care programmes, other than the trial options, identical?3 = care programmes clearly identical.
1 = clear but trivial differences, or some evidence of comparability.
0 = not mentioned or clear and important differences in care programmes.
Examples of clinically important differences in other interventions were: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation. Note, operator experience was not listed in the original review, though it was considered.

(8) Were the inclusion and exclusion criteria for entry clearly defined?3 = clearly defined.
1 = inadequately defined.
0 = not defined.
In contrast to the surgical treatment review, a clear description of fracture type or displacement was not essential, although still preferable, for the top score.

(9) Were the outcome measures used clearly defined?3 = clearly defined.
1 = inadequately defined.
0 = not defined.

(10) Were the accuracy and precision, with consideration of observer variation, of the outcome measures adequate; and were these clinically useful and did they include active follow up?3 = optimal.
1 = adequate.
0 = not defined, not adequate.
Active follow up was not considered explicitly in the original review.

(11) Was the timing (e.g. duration of surveillance) clinically appropriate?3 = optimal. (> 1 year)
1 = adequate. (6 months - 1 year)
0 = not defined, not adequate. (< 6 months)
In the original version of this review, the criterion for an optimal score was "1 year and above", rather than above one year.

 
Table 3. Numbers and status of studies in the published versions of the review

VersionTrial statusChanges

1st version
Issue 2, 1999
The original review had 29 included trials and 1 trial awaiting assessment.

2nd version
Issue 3, 2001
The first update had 31 included trials, 5 excluded studies and 3 studies listed as ongoing.Three new trials were included (Cornwall 2001; Kongsholm 1981; Stoffelen 1998); one previously included trial (Milliez 1992), investigating the duration of immobilisation after surgical treatment, was excluded; three newly identified trials were placed in the ongoing trials category and four others were excluded. Additional findings were included from newly identified reports of five already included trials (Bunger 1984; Gibson 1983; Moir 1995; Sarmiento 1980; Stewart 1984).The results of our contact of trialists of the three studies only published as conference abstracts (Gibson 1983; McMillan 1996; Ross 1984) are summarised in the Notes section of the Characteristics of Included Studies Table.

3rd version
Issue 2, 2002
The second update had 33 included trials, 6 excluded studies, 3 listed as ongoing studies and 1 study awaiting assessment.Two studies (Aladin 2001; Ho 1986) were newly included. Of the three other newly identified trials, one (Harris 2002) was ongoing (see Characteristics of Ongoing Studies Table), one (Cohen 2001), pending further response from the lead trialist, was placed in Studies Awaiting Assessment and one (Davison 2001) was excluded (see Characteristics of Excluded Studies Table). Additional trial reports were identified for three already included trials (Bunger 1984; Cornwall 2001; Stewart 1984), one (Aladin 2001) formerly listed as an ongoing trial (Moran 1999) and one already excluded trial (Smith 1999). The new report of Cornwall 2001 showed that the previous report (Cornwall 2000) was an interim analysis of 70 out of the 127 patients in the trial.

4th version
Issue 2, 2003
The third update had 36 included trials, 11 excluded studies, 1 listed as ongoing and 3 studies awaiting assessment.Of seven newly identified studies, two were included (O'Connor 2002; Tumia 2003), one excluded (Moran 2002), one was ongoing (Hearne 2003) and three (Jackson 2002; Kowalski 2002; Shah 2002) were placed in Studies Awaiting Assessment; pending further information from trialists. Upon obtaining separate data for patients with distal radial fracture, one trial (Cohen 2001) previously in Studies Awaiting Assessment was included. Inquiries on the progress and status of three trials (Harris 2002; Singhania 2001; Shanker 2000), formerly listed in Ongoing studies, resulted in their exclusion. One trial (Pool 1973), often mistakenly referred to as a randomised trial, was also added to the excluded trials list.

5th version
Issue 2, 2004
The fourth update had 36 included trials, 14 excluded studies and 2 studies awaiting assessment.The only newly identified study (Shah 2003) was excluded. A study (Hearne 2003) previously listed as ongoing was excluded as was another study (Kowalski 2002), previously listed in Studies Awaiting Assessment. The two other studies (Jackson 2002; Shah 2002) in Studies Awaiting Assessment were retained, again pending further information from trial investigators.

6th version
Issue 4, 2005
The fifth update had 38 included trials, 15 excluded studies and 2 studies awaiting assessment.The two newly identified trials (Liebman 2004; Sahin 2005) considered for this, the fifth, update, have been left in 'Studies awaiting assessment': Liebman 2004 awaits publication and Sahin 2005, located only after the month of last search (June 2005), awaits translation from Turkish. Further abstracts were located for both trials (Jackson 2002; Shah 2002) previously in 'Studies awaiting assessment'. further information from the trialists from these two trials has not been forthcoming. We have, however, now included the former trial (Jackson 2002) but excluded the latter study (Shah 2002), which is unlikely to be anything more than the self-declared prospective comparison.