External fixation versus conservative treatment for distal radial fractures in adults

 

Characteristics of included studies [ordered by study ID]

Abbaszadegan 1990

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Methods	Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: possible (5 in POP group analysed separately but data given) Loss to follow up: 1 died in Ext-fix group
Participants	Teaching hospital, Sweden 47 participants Inclusion criteria: "severely displaced Colles' fracture", displaced (= or > 5 mm radial shortening) distal radial fracture (Older type 3 and 4), patient consent Exclusion criteria: age > 75 years, addicts, mental incapacity, neuromuscular disturbance or warfarin treatment Classification: Older (type 3 and 4) (extra- and intra-articular) Sex: 36 female Age: mean 63 years; range 22 - 75 years Assigned: 23/24 [Ext-fix / POP] Assessed: 22/24 (at 1 year)
Interventions	Timing of intervention: not stated, but after X-ray examination (1) External fixation: closed reduction under local anaesthesia, temporary dorsal plaster cast. External Hoffman fixator applied at 1 to 3 days under regional anaesthesia: 2 pins inserted through 1 cm skin incision through middle of second metacarpal and 2 pins in radius. Fixator removed at 4 weeks (mean 31 days) (2) Conservative treatment: closed manipulation under local anaesthesia, then below elbow plaster cast for 4 weeks (mean 31 days)
Outcomes	Length of follow up: 1 year; also assessed at 10-12 days, 4, 8, 12 and 24 weeks. (1) Functional: subjective function (VAS: 0 to 10: normal), overall grading (Lidstrom 1959) including activities of daily living, pain, loss of motion and deformity. Pain (VAS 0 to 10: worst), grip strength, range of movement (flexion, extension, radial deviation, ulnar deviation, forearm rotation). (2) Clinical: complications: redislocation resulting in secondary external fixation, pin track infection (all resolved), osteomyelitis (none), pin loosening (none), transient sensory disturbance of the superficial radial nerve. (3) Anatomical: X-ray initially, at reduction, after 10-12 days, 4 and 8 weeks. Radial shortening and dorsal angulation.
Notes	Five in plaster group required remanipulation and had external fixation. Separate data were provided for this group.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Hegeman 2004

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Methods	Randomised by random selection of envelopes containing a piece of paper with the treatment allocation Assessor blinding: not reported Intention-to-treat analysis: likely Loss to follow up: probably none
Participants	Teaching hospital, The Netherlands 32 participants Inclusion criteria: unstable intra-articular distal radial fracture (> 10 degrees dorsal angulation and < 20 degrees radial inclination and > 3 mm positive ulnar variance) (AO C2 or C3). Age 55 to 80 years. Exclusion criteria: previous distal radial fracture or unable to perform functional evaluation Classification: AO (type C2 or C3) (all intra-articular) Sex: 29 female Age: mean 70 years Assigned: 15/17 [Ext-fix / POP] Assessed: 15/17 (at 1 year)
Interventions	Timing of intervention: not stated, but after X-ray examination (1) External fixation: reduction then application of Hoffmann II compact external fixator: 2 pins inserted into the second metacarpal and 2 pins in radial shaft. Fixator removed after 6 weeks (2) Conservative treatment: closed manipulation then below elbow plaster cast for 6 weeks Physiotherapy started after 6 weeks.
Outcomes	Length of follow up: 1 year; also assessed at 6 weeks, and 3 and 6 months. (1) Functional: problems in daily life (lifting cup, wringing, fine hand co-ordination, heavy load bearing), overall grading (Gartland 1951) including subjective evaluation of impairment, range of motion, residual deformity and complications. Pain (in joints), grip strength (hand and index finger), range of movement (flexion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: "complications of plaster immobilisation" (loose plaster; swollen thumb), pin track infection, transient neuropraxia, RSD, Dupuytren contracture. Deformity: prominent dinner fork deformity, radial deviation of hand. (3) Anatomical: X-ray initially, after treatment, and all follow-up times. Radial shortening, radial inclination, dorsal angulation, ulnar variance. Intra-articular alignment: step off.
Notes	Details on method of randomisation and plaster cast complications received from Dr Hegeman on 10 October 2006.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Horne 1990

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Methods	Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: no, baseline information or interim results not given for 8 participants; discrepancies in numbers followed in the two groups Loss to follow up: 5 lost and 3 dead by final follow up (4 to 15 months)
Participants	Teaching hospital, New Zealand 37 participants Inclusion criteria: displaced fractures of the distal radius judged as requiring reduction by resident on call. Age > 60 years. Informed consent. (Implied Colles' fractures.) Exclusion criteria: none stated Classification: Frykman (included Frykman 1, 2, 3, 4, 5 and 8) (extra- and intra-articular) Sex: not given Age: of 29 analysed, mean 72 years, range 61 - 91 years Assigned: ?/? [Ext-fix / POP] Assessed: 15/14 or 16/13 (see notes) (at final follow up 4-15 months)
Interventions	Timing of intervention: not stated but after presentation at fracture clinic; patients in the surgical group were admitted to a day-care facility. (1) External fixation: closed reduction under ischaemic arm block then modified AO tubular external fixator for 5 weeks: 2 pins placed at right angles in 2nd metacarpal, 2 pins placed at right angles into dorsoradial aspect of distal radius. "Stab incisions" of pins. (2) Conservative treatment: closed reduction under ischaemic arm block then below-elbow backslab, 10-15 degrees palmar flexion and ulnar deviation, for 5 weeks. Physiotherapy afterwards if wrist or hand stiffness.
Outcomes	Length of follow up: 4 to 15 months; also assessed at 1 and 5 weeks. (1) Functional: overall grading (not referenced but seems to be Stewart 1985, modification of Gartland 1951) including subjective (pain, disability, activity restriction, movement limitation) and objective (range of movement, finger flexion, grip strength, radial/median neuritis) measures. (2) Clinical: complications: remanipulation (none), pin track problems (21%), radial nerve neuritis (26%), RSD (none) (3) Anatomical: X-ray initially, at reduction, and final follow-up. Dorsal displacement and radial displacement (Van der Linden 1981).
Notes	Abstract (Devane 1988) gives an inconsistent report of trial: 34 patients, minimum 6 months follow-up, some correlation between radiological result and functional outcome, external fixation group held reduction significantly better, no mention of radial nerve irritation. Highly critical letter from Axelrod 1991. Comments on entry criteria (how displaced were the fractures?), length of follow up, advised small open incisions instead of percutaneous pinning. Response from Horne did not address these issues. Numbers at final follow up in each group varied in the main trial report (15/14 or 16/13). The two measures of displacement: dorsal displacement and radial displacement (Van der Linden 1981) are not in common use and prevent comparison with other trials.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Howard 1989

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Methods	Method of randomisation not stated Assessor blinding: not reported; independent assessment of functional and 10 year radiological outcome Intention-to-treat analysis: likely Loss to follow up: 6 (or 7) lost and 4 dead at 10 years
Participants	General hospital, UK 50 participants Inclusion criteria: severely displaced (30 degrees of dorsal angulation or over 10 mm radial shortening) comminuted Colles' fracture Exclusion criteria: age > 75 years Classification: not stated (intra-articular definitely included) Sex: not given (both sexes) Age: mean 47 years Assigned: 25/25 [Ext-fix / POP] Assessed: 21/19 (or 21/18) (at 10 years)
Interventions	Timing of intervention: not stated, but probably soon after hospital admission; surgery was usually done on the next available trauma list. (1) External fixation: medium-C Hoffman external fixator: 2 pins inserted into middle of 2nd and 3rd metacarpals, 2 into radial shaft. Fixator locked after reduction (under image intensifier). Removed after 5 to 6 weeks. (2) Conservative treatment: closed manipulation under Bier's block and below-elbow backslab, completed next day (remanipulation if initial reduction was unsatisfactory). Plaster cast for 5 to 6 weeks. All had physiotherapy afterwards.
Outcomes	Length of follow up: 10 years (mean 10.25 years); also assessed at 1, 2, 5 and 13 weeks and 6 months. (1) Functional: overall grading (Gartland 1951; Stewart 1984) including subjective (pain, disability, activity restriction, movement limitation) and objective (range of movement, finger flexion, grip strength, radial/median neuritis) measures. (2) Clinical: complications: remanipulation, fixator distraction increased, pin track infection, radial nerve neuritis, Sudeck's atrophy (none), tendon (EPL) rupture, median nerve compression, ulnar nerve compression, osteoarthritis. Cosmetic appearance, patient satisfaction, osteoarthritis (3) Anatomical: X-ray initially, at reduction, and all follow-up times. Dorsal angulation, radial shift, radial shortening and radial deviation. Overall anatomical score (Stewart 1984), radiological deformity (Dias 1987), arthritis (Knirk and Jupiter 1986)
Notes	Anatomical results presented graphically in main paper. 10 years follow up reported in two separate abstracts (Freeman 1998; Freeman 2000). Slight discrepancies between the two abstracts in the numbers lost to follow up at 10 years and final functional result for the fixation group.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Jenkins 1989

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Methods	Randomised by date of birth Assessor blinding: not done Intention-to-treat analysis: problems including disparities in reported inclusion criteria and 24 excluded from analyses, including 17 with follow up < 12 months after fracture union, 3 allocated external fixation (2 had premature removal of fixator due to recurrent infections and 1 had an iatrogenic radial shaft fracture) and 4 allocated plaster casts who were given external fixation after remanipulation. Loss to follow up: 29 (including 24 exclusions)
Participants	Teaching hospital, UK 153 participants Inclusion criteria: displaced distal radial fracture (Colles' fractures) requiring manipulation, unilateral, age < 65 years (or < 60 years in journal publications: see Notes) Exclusion criteria: radiographic evidence of osteoporosis Classification: Frykman (extra- and intra-articular) Sex: not given Age: mean 44 years Assigned: 84/69 [Ext-fix / POP] Assessed: 68/56 (13+ months)
Interventions	Timing of intervention: probably reduction at fracture clinic, external fixation on day of injury or next day. (1) External fixation: closed reduction and usually overnight hospital admission (tended to be day cases later on in trial) for AO/ASIF external mini-fixator (in 'Z' or box configuration) application under general anaesthesia. Two proximal Kirschner wires at right angles into radial shaft (stab incisions) and 2 distal wires at right angles transfixed comminuted distal fragments. Insertion under image intensified using a power drill. Wrist usually mobile but no physiotherapy. Fixator removed after 4 weeks. (2) Conservative treatment: closed manipulation under intravenous sedation, then dorsal plaster slab, completed at 1 week. Cast removed after 4 weeks. Crepe bandage and mobilisation. Immobilisation increased by one week if non-union at 4 weeks. There was no formal physiotherapy.
Outcomes	Length of follow up: 13 months (12 months after union); also assessed at 1 and 4 weeks and 2 and 4 months. (1) Functional: range of movement (flexion, extension, radial and ulnar deviation, pronation, supination), mass grip strength. Overall grading (Stewart 1985, modification of Sarmiento) including subjective and objective outcomes. (2) Clinical: complications (* = no data given for POP group): remanipulation (4 in POP group in Masters thesis but 6 in 1988 report), pin track infection, serious infection (recurrent and deep), osteomyelitis, premature frame removal, pin site fracture (radial shaft), median nerve compression (none), sensory changes in superficial radial nerve (11 of which 2 permanent in Ext-fix group), ulnar nerve problems (none), unstable distal radial-ulnar joint restricting supination* (2 of 3 had reconstructive surgery, RSD (2/24 of the POP group had shoulder-hand syndrome in the 1987 report) (3) Anatomical: measured at post reduction, union (4 weeks), and 1 and 13 months post union. Dorsal angulation, radial shortening, radial length. Overall and changes in anatomical grading (Stewart 1985)
Notes	Initially, in the first version of the overall review, this trial was reported as 2 trials: Jenkins 1987 and Jenkins 1988. Similarities were noted and we suggested that there may be shared patients. This was confirmed on communication with the lead trialist who indicated that these were both "pilot studies" in an overall larger study which formed his Masters thesis. In Handoll 2003a, the results presented in this thesis replaced those presented previously. There were several inconsistencies noted between the various trial reports. One is that the upper age limit was stated to be 60 years in the journal publications and 65 years in the thesis. Another is that there were 6 remanipulations in the POP group registered in the 1988 report but only 4 (all leading to external fixation and subsequent exclusion from the analyses) in the thesis. It is likely that the date of last follow up was set up as at least 12 months from union, rather than exactly 12 months from union, and some participants may have been followed up for 3 years.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	No	C - Inadequate

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Kapoor 2000

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Methods	Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: not known, loss to follow up deduced from paper Loss to follow up: 20 (at 4 years)
Participants	Teaching hospital, India 61 participants (in review comparison: see Notes) Inclusion criteria: acute displaced intra-articular distal radius fracture, adult. Dorsal or volar displacement. Exclusion criteria: not given Classification: Frykman 3, 4, 7 & 8 (and AO) (intra-articular) Sex: 15 female Age: mean 39 years (of 90) Assigned: 28/33 [Ext-fix / POP] Assessed: 18/23 (at 4 years)
Interventions	Timing of intervention: not stated, but acute injury. (1) External fixation: Roger and Anderson external frame fixator: 2 pins into 2nd and 3rd metacarpals, 2 into radius shaft. Patients encouraged to use limb (eating etc) and rotate forearm. Fixator removed 6-7 weeks. Splint for 2 days after removal of fixator, then mobilisation. (2) Conservative treatment: closed reduction and plaster cast. Remanipulated once if necessary. Immobilisation for 6 to 7 weeks.
Outcomes	Length of follow up: average 4 years; also assessed at 1 week and 6 to 7 weeks (certainly Ext-fix and POP groups). (1) Functional: overall grading (Sarmiento 1975) including subjective evaluation, objective evaluation, residual deformity, and complications. Range of movement (flexion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: redisplacement (not enumerated), pin track infection, CTS (resolved), finger stiffness (all resolved), RSD (resolved). Residual cosmetic deformity (3) Anatomical: X-ray at reduction, and probably other times (see above). Radial shortening, dorsal tilt, volar angulation, articular step off. Overall grading (no reference)
Notes	Trial with 90 participants had 3 intervention groups. Excluded from this review are the 29 participants receiving open reduction and internal fixation using Kirschner wires, small T-plates or both. 70% of the whole trial population had fractures resulting from a road traffic accident. Discrepancies between functional grading in Table 2 and account in report abstract.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Kreder 2006

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Methods	Randomised by sealed opaque sequentially marked envelopes based on computer-generated random number sequences Assessor blinding: no (although independent research assistants) Intention-to-treat analysis: likely Loss to follow up: 28
Participants	3 teaching hospitals, Canada 113 participants Inclusion criteria: displaced distal radial fracture with metaphyseal comminution but without joint incongruity. Skeletally mature, aged 16 to 75 years. Stable congruous joint. Patient consent. Exclusion criteria: comminution > 1/3rd the anterior-posterior diameter of radius, dorsal tilt > 10 degrees, detectable step or gap at joint surface, history of previous wrist fracture, congenital anomaly or other severe wrist problem, not fit for surgery, definitive treatment could not be administered within 1 week, mentally incompetent, unable to write in English. Open fracture, associated ipsilateral extremity injuries, other significant system injuries. Classification: AO (extra- and intra-articular) Sex: 74 female Age: mean 53 years Assigned: 54/59 [Ext-fix / POP] Assessed: 44/41 (at 2 years)
Interventions	Timing of intervention: within 1 week of injury. (1) External fixation: closed reduction under regional anaesthesia. Application of the small spanning AO fixator: 2.5 mm pins into 2nd metacarpal and 4 mm pins into radius via 1 cm skin incision. Additional (in 19 cases) smooth Kirchner wires inserted from the radial styloid or dorsum of the radius across the fracture fragments at surgeon's discretion. Optional wires removed 4 to 6 weeks. Fixator removed between 6 to 8 weeks. (2) Conservative treatment: closed reduction under haematoma block (and fluoroscopy), then long arm splint with wrist in neutral and elbow at 90 degrees - reduction repeated if necessary. Splint converted to long arm cast within 14 days, reduced to short arm cast at 3 to 4 weeks, removed 6 to 8 weeks. Finger exercises during fixator or cast use, and wrist exercises post immobilisation. All participants received supervised physiotherapy [until maximum range of motion was achieved].
Outcomes	Length of follow up: 2 years; also assessed at 1, 2, 3, 4 and 6 weeks, and 6 and 12 months. (1) Functional: Musculoskeletal Function Assessment (upper extremity) and SF-36 (bodily pain domain) questionnaires. Job change because of injury. Jebsen Taylor hand function (Jebsen 1969); grip, pinch, pad and chuck strengths; range of movement (flexion, extension, radial deviation, ulnar deviation, pronation, supination). (2) Clinical: complications: secondary treatment resulting from redisplacement (open reduction and internal fixation for I Ext-fix and external fixation for 5 POP); distal radial ulnar joint instability (one Ext-fix had ulnar styloid repair), pin track infection, superficial infection, deep infection, RSD. (3) Anatomical: X-ray at reduction, and other times up to 6 months (see above). Union, radial shortening and palmar tilt restoration.
Notes	Further details of method of randomisation and rehabilitation received from Julie Agel on 10 October 2006. Some percentages in Table 1 in the trial report giving baseline data and results did not correspond to stated numbers available at baseline or at follow up times.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Yes	A - Adequate

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Lagerstrom 1999

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Methods	Randomised using computer, "within 6 unit blocks" Assessor blinding: not reported Intention-to-treat analysis: problems including 2 exclusions. Five in POP group who received secondary external fixation were analysed separately; data from the 5 males in the Ext-fix group also remove from the analyses of grip strength Loss to follow up: 2 (excluded)
Participants	Teaching hospital, Sweden 35 participants Inclusion criteria: displaced (3+ mm radial shortening; 10+ degrees dorsal or 10+ degrees radial angulation of the radius) distal intra-articular Colles' fracture involving distal radio-ulnar joint. Age 45 to 75 years. Feasible to use plaster cast or external fixator Exclusion criteria: medical conditions or language difficulties that might interfere with outcome. Classification: Frykman (5 to 8) (intra-articular) Sex: 30 female Age: mean 58 years; range 45 - 72 years (of 33) Assigned: 18/17 [Ext-fix / POP] Assessed: 16/15 (at 2 years)
Interventions	Timing of intervention: not stated. No mention of method of reduction. (1) External fixation: light (in weight) non-cylindrical AO external fixator. Immobilised for 6 weeks. (2) Conservative treatment: cylindrical below elbow plaster cast for 6 weeks. Physiotherapy started soon (same day or next day) after fracture had been immobilised, in both groups.
Outcomes	Length of follow up: 2 years; also assessed at up to 10 days, 6, 10 and 18 weeks and 1 year. (1) Functional: grip strength, and pain during grip measurements. (2) Clinical: complications: redisplacement requiring treatment change, refracture. (3) Anatomical: no information. Redisplacement with 10 days.
Notes	Five in POP group required remanipulation and had external fixation. This group was analysed separately. Separate analyses were also undertaken for the 5 male patients, all in the external fixation group.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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McQueen 1996

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Methods	Randomised by closed envelopes Assessor blinding: not reported Intention-to-treat analysis: likely Loss to follow up: 8 (at 1 year)
Participants	Teaching hospital, UK 90 participants (in review comparison: see Notes) Inclusion criteria: redisplaced unstable distal radial fracture (redisplaced to >10 degrees dorsal angulation or radial shortening > 3 mm) Exclusion criteria: inadequate primary reduction, > 2 weeks from injury to recognised instability, displaced articular fragments requiring open reduction, previous malunion, mental incapacity Classification: AO (A and C) (extra-articular and intra-articular) Sex: 81 female Age: mean 63 years, range 16 - 86 years (of 120 patients) Assigned: 30/30/30 [Ext-fix / Ext-fix with early mobilisation / POP] Assessed: 28/26/28 (at 1 year)
Interventions	Timing of intervention: under 2 weeks from injury (1) External fixation: closed reduction and Pennig external fixator. Two pins inserted into 2nd metacarpal and 2 into radial shaft using an open technique. Ball joint locked. Fixator removed after 6 weeks. (2) External fixation: as above (1) but release of ball joint of fixator at 3 weeks to allow wrist movement. (3) Conservative treatment: closed manipulation, then forearm cast for 6 weeks. Physiotherapy prescribed on "purely clinical grounds". Patients did not receive physiotherapy when the fixator was in place.
Outcomes	Length of follow up: 1 year; also assessed at 6 weeks, 3 and 6 months. (1) Functional: activities of daily living (own scale), mass grip strength, other grips, pain (VAS 0 to 10: no data), range of movement (overall, flexion and extension). (2) Clinical: complications: recurrent instability, malunion, pin track infection, RSD, CTS, dorsal medial neuropraxia (superficial radial nerve?), EPL rupture (none), carpal collapse. (3) Anatomical: X-ray at all follow-up times. Dorsal angulation, radial shortening, carpal malalignment, malunion.
Notes	Trial with 120 participants had 4 intervention groups. Excluded from this review are the 30 participants receiving open reduction and bone graft held in place with a single Kirschner wire.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Pring 1988

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Methods	Method of randomisation not stated Assessor blinding: not reported, two assessors worked independently of each other Intention-to-treat analysis: No, the results from 9 people allocated plaster cast but treated with external fixation after redisplacement were stated as being put into a separate group for "purposes of analysis". They were presented in the surgical group for surgical complications. Loss to follow up: 9 (at 6 months)
Participants	District general hospital, UK 75 participants with 76 fractures Inclusion criteria: Colles' fracture, displaced distal radius fracture Exclusion criteria: not stated Classification: extra- and intra-articular Sex: 61 female Age: mean 62 years Assigned: 36/39 (40 fractures) [Ext-fix / POP] Assessed: ?/? (66 available at 6 months)
Interventions	Timing of intervention: not stated, but at accident and emergency department after closed reduction via traction using finger traps under a haematoma block (1) External fixation: "bipolar fixation". Two half pins inserted percutaneously into the radial shaft and secured in both cortices and one pin through the thumb metacarpal at 90 degrees to the radial pins. Pins incorporated into a padded forearm cast with wrist in neutral position. (2) Conservative treatment: plaster of Paris forearm cast applied under traction with wrist in neutral position and forearm pronated. In both groups, the completed casts were split down the ulnar border. Early hand function was encouraged. If necessary, participants attended a daily hand class before and after cast removal, which was after 5 weeks.
Outcomes	Length of follow up: 6 months; also assessed at 1, 2, 5, 7 and 12 weeks. (1) Functional: overall grading (Scheck 1962: based on Gartland 1951) included subjective evaluation, wrist appearance, wrist and finger movements, grip, radiological assessment. Grip strength. (2) Clinical: complications: redisplacement (all in POP group treated with external fixation). All those (45) who had external fixation including 9 people allocated POP: thumb pain (9 ), migrated pin (1), fracture through pin hole (1), pin loosening or infection (7) (3) Anatomical: X-ray at reduction, 1, 2, 5 and 12 weeks. Radial length, volar angle, radial angle.
Notes	Preliminary results presented at a conference (Pring 1986) were for 51 participants.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Rodriguez-Merchan 92

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Methods	Method of randomisation not stated, claimed to be "double-blind" Assessor blinding: not stated Intention-to-treat analysis: likely Loss to follow up: probably none
Participants	Teaching hospital, Spain 70 participants Inclusion criteria: comminuted intra-articular distal radial fracture, Frykman 3 to 8 Exclusion criteria: > 45 years Classification: Frykman (3 to 8) (intra-articular) Sex: 12 female Age: mean 36 years; range 20 - 45 years Assigned: 35/35 [Ext-fix / POP] Assessed: 35/35 (1 year)
Interventions	Timing of intervention: probably reduction on first day, external fixation on first or next day. (1) External fixation: reduction under general anaesthesia or brachial block. Clyburn dynamic external fixator: 2 pins driven into radial diaphysis and 2 into diaphysis of 2nd metacarpal. Overnight hospital admission. Posterior splint applied for 3 weeks if joint disrupted; transverse pin inserted for 3 weeks if joint unstable. Device removed after 7 weeks. Pin sites dressed by medical staff at weekly intervals (2) Conservative treatment: closed manipulation under local anaesthesia, then forearm plaster. Remanipulation at 1 week if position unacceptable. Total 7 weeks, unless problems when kept for 1 more week. Before discharge, patients were given instructions to mobilise fingers and shoulder.
Outcomes	Length of follow up: 1 year; also assessed at 1, 3 and 7 weeks. (1) Functional: overall grading (Horne 1990, thus probably based on Stewart 1985) based on subjective and objective outcomes. (2) Clinical: complications: remanipulation (offered), pin track infection, pin loosening, premature frame removal (none), joint infection (none), osteomyelitis (none), pin breakage (none), RSD (Sudeck's atrophy requiring intensive physiotherapy), tendon or nerve injuries (none), non-union (none) (3) Anatomical: X-ray at 1, 3 and 7 weeks. Dorsal angulation, radial shortening, radial length. Overall grade (Stewart 1985 based on Lidstrom 1959 and Sarmiento 1975)
Notes	First author listed as Merchan ECR in article. Journal is now American Journal of Orthopedics.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Roumen 1991

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Methods	Method of randomisation not stated Assessor blinding: not reported Intention-to-treat analysis: not known, but some of the 19 patients who had died (2) or were lost to follow up (17) from the original study group may have belonged to the randomised trial. Lost to follow up: not known - see above
Participants	General hospital, The Netherlands 43 participants followed up Inclusion criteria: redisplaced Colles' fracture with dorsal angulation > 10 degrees or radial shortening > 5 mm. Age > 55 years (all intra-articular) Exclusion criteria: not stated Classification: Frykman and Sarmiento (intra-articular) Sex: not given (predominantly female) Age: not given, > 55 years Assigned: ?/? reported 21/22 [Ext-fix / POP] Assessed: 21/22 (6 months)
Interventions	Timing of intervention: all patients had initial fracture reduced, within 6 hours of injury, under local anaesthesia and treated with plaster backslab, which we assume was completed to a forearm plaster cast. Seen 1, 7 and 14 days. Allocation at 2 weeks if fracture redisplaced (see inclusion criteria). (1) External fixation: fracture remanipulated under regional anaesthesia and Ace Colles external fixator applied for 5 weeks (2) Conservative treatment: forearm plaster cast continued for a further 5 weeks
Outcomes	Length of follow up: 6 months; also assessed post manipulation and 5 weeks on removal of plaster cast or fixator. (1) Functional: overall grading by de Bruijn 1987 and Lidstrom 1959 systems, pain (at rest, on movement, on ulnar pressure), grip strength. (2) Clinical: complications: pin loosening, pin track infection (none), RSD (serious RSD: 2/1), CTS (no data), tenosynovitis (no data), EPL rupture. Cosmetic appearance: specially not noted. (3) Anatomical: X-ray post re-MUA and on removal of plaster cast or external fixator. Overall grading Lidstrom 1959 and Sarmiento 1980. Also volar angle, radial shortening, radial angle and radial shift.
Notes	A third group of patients who did not have redisplacement at 2 weeks were also followed up.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

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Stein 1990

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Methods	Randomised by day of hospital admission Assessor blinding: not reported Intention-to-treat analysis: not known Lost to follow up: not stated, perhaps none
Participants	Teaching hospital, Israel 62 participants Inclusion criteria: displaced comminuted distal radial fracture (Older type 3 and 4: Colles' fracture). Shortening of distal radius 1 to 4 mm below distal ulna (Older type 3) or greater. Exclusion criteria: none stated Classification: Older (type 3 and 4) (all intra-articular) Sex: not given Age: mean 50 years; range 19 - 79 years Assigned: 40/22 [Ext-fix / POP] Assessed: 40/22
Interventions	Timing of intervention: not stated but after presentation at fracture clinic; participants of the surgical group were either admitted into hospital for 24 hours or to a day-care facility. Fractures reduced under regional or general anaesthesia. (1) External fixation: closed reduction then the "small" AO external tubular fixator, usually for 6 weeks: 2 pins placed in 2nd metacarpal, 2 pins placed into radial shaft. (2) Conservative treatment: closed reduction then above-elbow plaster cast with the forearm in pronation, usually for 6 weeks.
Outcomes	Length of follow up: 6 months to 4 years (mean 3 years); also assessed at 1, 2, 4 and 6 weeks. (1) Functional: overall grading split by subjective (pain, deformity, grip strength, inability to return to previous activities) and objective results using Gartland 1951. (2) Clinical: complications: remanipulation, pin track infection (all resolved), pin loosening, breakage (none), osteomyelitis (none), superficial radial nerve irritation (temporary), RSD (3) Anatomical: X-ray initially and at all follow-up times. Dorsal angulation, radial shortening, radial angulation and shift. Overall grading of deformity (Van der Linden 1981).
Notes	Results for another 64 patients with extra-articular fractures were treated with an above-elbow plaster cast were also presented in the trial report. However, these were not part of the trial.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	No	C - Inadequate

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Young 2003

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Methods	Randomised using closed envelopes Assessor blinding: not reported (independent physiotherapist at 7 years) Intention-to-treat analysis: losses accounted for. (Late decision to exclude data for a person with rheumatoid arthritis) Loss to follow up: 39 (at 7 years)
Participants	General hospital, UK 125 participants Inclusion criteria: displaced Colles' fracture, unilateral, dorsal angulation > 10 degrees, radial shortening > 2 mm, age 16 - 75 years Exclusion criteria: bilateral fracture, associated fractures of ipsilateral limb, die punch fractures, multiple injuries, unable to understand purpose of study Classification: Frykman (extra-articular and intra-articular) Sex: 97 female Age: mean 57 years; range 16 - 75 years Assigned: 59/66 [Ext-fix / POP] Assessed: 48/60 (at 1 year); 36/50 or 36/49 (at 7 years)
Interventions	Timing of intervention: not stated (1) External fixation: manipulation and application of bridging Pennig dynamic fixator under general anaesthesia. Pins inserted percutaneously into 2nd metacarpal and under direct vision into the radial shaft. Distal ball joint unlocked at 3 weeks, fixator removed at 6 weeks (2) Conservative treatment: manipulation under regional or general anaesthesia and application of below elbow plaster backslab; then completed to full below-elbow plaster cast at 1 week and removed at 6 weeks
Outcomes	Length of follow up: 7 years (mean 7.8 years); also assessed at 1, 2, 6 and 9 weeks, 3, 6, 12 and 18 months and 2 years. (1) Functional: difficulties in two aspects of activities of daily living, grip strength, range of movement (pronation, supination, flexion, extension, radial and ulnar deviation) from 9 weeks onwards. Use of wrist splint. Persistent wrist pain (1 in conservative group had rheumatoid arthritis at 7 years). Time to return to normal activities and work. Overall grades (Gartland 1951) at 7 years. (2) Clinical: complications: redisplacement by 2 weeks, remanipulation, malunion, median nerve neuropathy, pin site infection (all superficial), radial nerve neuropathy, RSD (including 1 versus 3 persistent at 1 year, and 1 versus 0 at 7 years), EPL tendon rupture, osteoarthritis (signs: just one with symptoms). Patient satisfaction, unsightly forearm scars (from external fixator) (3) Anatomical: X-ray initially, pre-operatively at reduction and all the above times. Radial shortening, radial shift, radial and dorsal angulation. Malunion. Osteoarthritis (Knirk 1986)
Notes	The full publication of the 7 year results is new to this review and is the first full report of this trial previously only reported in abstracts. The trial appeared as Young 2002 in Handoll 2003a, and as Nanu 1994 in first version of that review. For Handoll 2003a, Miss Young provided copies of the drafts of 3 papers, submitted for journal publication, and also provided answers to further queries. There are differences in presentation between the draft and published reports of the 7 year results. These include the general use of medians in the published report and the exclusion of data for one person with rheumatoid arthritis.
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	Unclear	B - Unclear

---

Zheng 2003

---

Methods	Randomised by admission number Assessor blinding: not reported Intention-to-treat analysis: not known Lost to follow up: not stated, probably none
Participants	Military (police) hospital, China 29 participants Inclusion criteria: closed unstable distal radial fracture Exclusion criteria: none stated Classification: Universal classification (Cooney) IIB, IIC (extra-articular), IVB, IVC (intra-articular) Sex: 14 female Age: range 18 - 52 years Assigned: 12/17 (if none lost to follow up) [Ext-fix / POP] Assessed: 12/17 (at 1 year)
Interventions	Timing of intervention: not stated. Participants were either outpatients or inpatients. (1) External fixation: closed (5 participants) or open (7 participants) reduction under brachial plexus block. Then application of small size Zhongjia SGD-type unilateral multifunctional external fixator: 2 pins inserted through skin incisions (0.7 cm) into the second metacarpal and 2 pins through skin incisions in radial shaft. Kirschner wire added if fracture was still unstable. Wrist fixed in medial position, slight extension and ulnar deviation or volar flexion (opposite to the direction of the injury). Fixator made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks. Immediate functional training finger mobilisation; then, finger, elbow and shoulder from week 2; wrist joint mobilisation and strengthening activities from week 4. (2) Conservative treatment: manual reduction under haematoma block with X-ray monitoring. Plaster of Paris short-arm (forearm) cast applied, position changed after 2 weeks to "medial". Cast removed after 6 weeks. Functional training was done before and after removing the cast.
Outcomes	Length of follow up: 1 year; also assessed at 2 and 6 weeks. (1) Functional: overall grading (Sarmiento 1975) including subjective evaluation of activity restriction and pain, objective evaluation of function, range of motion (loss of flexion or extension rated) and grip strength. (2) Clinical: complications: loosened nail, injured superficial radial nerve, carpal tunnel syndrome. (3) Anatomical: X-ray initially, after treatment, and all follow-up times. Anatomical assessment (Stewart 1984), radial shortening, volar angulation, ulnar angulation
Notes	Translated from Chinese by Xiaoyan Chen
Risk of bias
Item	Authors' judgement	Description
Allocation concealment?	No	C - Inadequate

---

 <: less than
>: more than
AO: Arbeitsgemeinschaft fur Osteosynthesefragen / Association for the Study of Internal Fixation (or ASIF)
CTS: carpal tunnel syndrome
DISI: dorsal intercalated segment instability
EPL: extensor pollicis longus (tendon)
Ext-fix: external fixation
hypoaesthesia: decrease in sensation
K-wires: Kirschner wires
paraesthesia: numbness, tingling, "pins and needles" sensation
POP: plaster of Paris
ROM: range of movement (wrist and forearm)
RSD: reflex sympathetic dystrophy
VAS: visual analogue scale
VISI: volar intercalated segment instability
X-pins: crossed percutaneous pinning
References (listed above but not in Additional references)
* de Bruijn 1987
de Bruijn HP. Functional treatment of Colles fracture. Acta Orthopaedica Scandinavica Supplementum 1987; 223:1-95.
*Dias 1987
Dias JJ, Wray CC, Jones JM, Gregg PJ. The value of early mobilisation in the treatment of Colles' fractures. Journal of Bone & Joint Surgery - British Volume 1987; 69(3):463-7.
* Lidstrom 1959
Lidstrom A. Fractures of the distal end of the radius. A clinical and statistical study of end results. Acta Orthopaedica Scandinavica Supplementum 1959; 41:5-118.
*Sarmiento 1975
Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles' fractures. Functional bracing in supination. Journal of Bone & Joint Surgery - American Volume 1975; 57(3):311-7.
*Sarmiento 1980
Sarmiento A, Zagorski JB, Sinclair WF. Functional bracing of Colles' fractures: a prospective study of immobilization in supination vs. pronation. Clinical Orthopaedics & Related Research 1980; 146:175-83.

 

Characteristics of excluded studies [ordered by study ID]

---

Study	Reason for exclusion
Christensen 2001	Not a randomised comparison. Compares treatment with external fixation at one hospital with plaster cast at another hospital.
Kongsholm 1989	Not a randomised comparison. Use of historic controls.
Solgaard 1989	Includes patients from a randomised trial of conservative treatment but the patients in the external fixator group were not randomised.
Sprenger 1988	Insufficient information to include. Quasi-randomised trial (60 participants) reported only in an abstract. (Superior radiological results were reported for the external fixator group). Though one trialist provided brief details of the method of randomisation (alternation) and setting (emergency department), the likelihood of getting further information or the trial ever being published seems remote.
van Dijk 1996	Retrospective comparison.

---

 

Comparison 1. External fixation versus plaster cast

---

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

---

 1 Functional grading: not excellent

9

521

Risk Ratio (M-H, Fixed, 95% CI)

0.82 [0.71, 0.95]

---

 2 Functional grading: not excellent. Worst and best case scenarios sensitivity analyses

9

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

---

2.1 Sensitivity analysis 1: worst case for plaster cast

9

610

Risk Ratio (M-H, Fixed, 95% CI)

0.64 [0.55, 0.74]

---

2.2 Sensitivity analysis 2: best case for plaster cast

9

610

Risk Ratio (M-H, Fixed, 95% CI)

1.09 [0.95, 1.25]

---

 3 Functional grading: fair or poor

11

612

Risk Ratio (M-H, Fixed, 95% CI)

0.73 [0.55, 0.98]

---

 4 Subjective and objective functional evaluation

2

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

4.1 Subjective grading: not excellent

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

4.2 Subjective grading: fair/poor

2

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

4.3 Objective grading: not excellent

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

4.4 Objective grading: fair/poor

2

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 5 Upper extremity function part of Musculoskeletal Function Assessment tool (0 to 100: maximum disability)

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

5.1 At 6 months

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

5.2 At 1 year

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

5.3 At 2 years

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 6 Difficulties in activities of daily living

2

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

6.1 Lifting cup at 3 months

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.2 Lifting cup at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.3 Hand wringing at 3 months

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.4 Hand wringing at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.5 Fine hand co-ordination at 3 months

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.6 Fine hand co-ordination at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.7 Heavy load bearing at 3 months

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.8 Heavy load bearing at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.9 Difficulty in turning keys or taps at 7 years

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

6.10 Difficulty in picking up small objects and turning door handles at 7 years

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 7 Job change because of injury

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

7.1 At 6 months

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

7.2 At 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

7.3 At 2 years

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 8 Mass grip strength (% of normal side)

4

Mean Difference (IV, Random, 95% CI)

Totals not selected

---

8.1 Results at around 1 year

4

Mean Difference (IV, Random, 95% CI)

Not estimable

---

8.2 Results at 7 years follow up

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

 9 Grip, chuck and pinch strengths (injured - normal side): units not given

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

---

9.1 Grip strength at 2 years

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

9.2 Chuck strength at 2 years

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

9.3 Pinch strength at 2 years

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

 10 Maximal voluntary contraction: injured - uninjured side (Newtons)

1

Mean Difference (IV, Random, 95% CI)

Totals not selected

---

10.1 Results at 18 weeks

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

10.2 Results at 2 years

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

 11 Persistent pain (1 year & 7 years)

2

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

11.1 At 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

11.2 Radiocarpal pain at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

11.3 Ulnocarpal pain at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

11.4 Radioulnar pain at 1 year

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

11.5 At 7 years

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 12 Pain (6 months)

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

12.1 Pain at rest

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

12.2 Pain on movement

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

12.3 Ulnar compression pain

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 13 Range of movement at 1 year (% of normal side)

3

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

13.1 Flexion

2

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.2 Extension

2

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.3 Radial deviation

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.4 Ulnar deviation

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.5 Supination

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.6 Pronation

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.7 Flexion/extension

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

13.8 Overall range of movement

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 14 Range of movement at 2 years (injured - normal side)

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

14.1 Flexion (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

14.2 Extension (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

14.3 Radial deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

14.4 Ulnar deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

14.5 Supination (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

14.6 Pronation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 15 Range of movement at 1 year

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

15.1 Flexion (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

15.2 Extension (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

15.3 Radial deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

15.4 Ulnar deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

15.5 Supination (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

15.6 Pronation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 16 Range of movement at 7 years

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

16.1 Flexion (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

16.2 Extension (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

16.3 Radial deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

16.4 Ulnar deviation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

16.5 Supination (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

16.6 Pronation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 17 Complications

15

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

---

17.1 Redisplacement /recurrent instability

5

422

Risk Ratio (M-H, Fixed, 95% CI)

0.20 [0.13, 0.32]

---

17.2 Redisplacement resulting in secondary treatment

9

694

Risk Ratio (M-H, Fixed, 95% CI)

0.17 [0.09, 0.32]

---

17.3 Distal radial ulnar joint instability

1

113

Risk Ratio (M-H, Fixed, 95% CI)

1.64 [0.28, 9.44]

---

17.4 Plaster cast problems (swollen thumb; loose plaster)

1

32

Risk Ratio (M-H, Fixed, 95% CI)

0.23 [0.01, 4.35]

---

17.5 Pin track infection

11

846

Risk Ratio (M-H, Fixed, 95% CI)

12.02 [5.07, 28.49]

---

17.6 Pin loosening and other pin site problems

7

433

Risk Ratio (M-H, Fixed, 95% CI)

5.07 [1.34, 19.26]

---

17.7 Premature frame/fixator removal

3

313

Risk Ratio (M-H, Fixed, 95% CI)

3.25 [0.39, 27.00]

---

17.8 Osteomyelitis

4

332

Risk Ratio (M-H, Fixed, 95% CI)

2.47 [0.10, 59.70]

---

17.9 Wound infection

1

90

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

17.10 Tendon injury/rupture

5

339

Risk Ratio (M-H, Fixed, 95% CI)

0.26 [0.05, 1.52]

---

17.11 "Dorsal medial neuropraxia"

1

90

Risk Ratio (M-H, Fixed, 95% CI)

1.52 [0.06, 36.34]

---

17.12 "Transient neuropraxia"

1

32

Risk Ratio (M-H, Fixed, 95% CI)

2.27 [0.23, 22.56]

---

17.13 Median nerve compression /Carpal tunnel syndrome

6

508

Risk Ratio (M-H, Fixed, 95% CI)

0.50 [0.21, 1.15]

---

17.14 Radial nerve neuritis or neuropathy

3

204

Risk Ratio (M-H, Fixed, 95% CI)

2.55 [0.98, 6.68]

---

17.15 Superficial radial nerve paraesthesia or injury

4

291

Risk Ratio (M-H, Fixed, 95% CI)

7.71 [1.77, 33.54]

---

17.16 Ulnar nerve compression

2

203

Risk Ratio (M-H, Fixed, 95% CI)

0.2 [0.01, 3.97]

---

17.17 Reflex sympathetic dystrophy

11

731

Risk Ratio (M-H, Fixed, 95% CI)

1.31 [0.74, 2.32]

---

17.18 Severe finger stiffness

1

61

Risk Ratio (M-H, Fixed, 95% CI)

0.13 [0.01, 2.32]

---

17.19 Dupuytren contracture

1

32

Risk Ratio (M-H, Fixed, 95% CI)

5.63 [0.29, 108.63]

---

17.20 Arthritis

2

121

Risk Ratio (M-H, Fixed, 95% CI)

0.73 [0.40, 1.34]

---

17.21 Refracture

1

35

Risk Ratio (M-H, Fixed, 95% CI)

2.84 [0.12, 65.34]

---

 18 Reflex sympathetic dystrophy - exploratory analysis

11

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

---

18.1 Primary treatment

9

598

Risk Ratio (M-H, Fixed, 95% CI)

1.03 [0.53, 1.98]

---

18.2 Redisplaced fractures

2

133

Risk Ratio (M-H, Fixed, 95% CI)

2.67 [0.75, 9.47]

---

 19 Cosmetic deformity

2

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

19.1 Cosmetic deformity (undefined)

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

19.2 Prominent ulnar styloid

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

19.3 Radial deviation of hand

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

19.4 Residual dinner fork deformity

1

Risk Ratio (M-H, Fixed, 95% CI)

Not estimable

---

 20 Patient dissatisfied with wrist

1

Risk Ratio (M-H, Fixed, 95% CI)

Totals not selected

---

 21 Anatomical grading: not excellent

5

371

Risk Ratio (M-H, Fixed, 95% CI)

0.53 [0.45, 0.61]

---

 22 Anatomical grading: fair or poor

6

400

Risk Ratio (M-H, Fixed, 95% CI)

0.17 [0.11, 0.27]

---

 23 Anatomical displacement

5

Mean Difference (IV, Random, 95% CI)

Totals not selected

---

23.1 Loss in dorsal angulation (degrees)

0

Mean Difference (IV, Random, 95% CI)

Not estimable

---

23.2 Loss in radial angulation (degrees)

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

23.3 Loss in radial length (radial shortening) (mm) at around 1 year follow up

4

Mean Difference (IV, Random, 95% CI)

Not estimable

---

23.4 Loss in radial length (radial shortening) (mm) at 7 years follow up

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

23.5 Loss in dorsal displacement (mm)

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

23.6 Loss in radial displacement (mm)

1

Mean Difference (IV, Random, 95% CI)

Not estimable

---

 24 Anatomical measurements

6

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

---

24.1 Dorsal angulation (degrees) at 13 weeks to 13 months follow up

6

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

24.2 Dorsal angulation (degrees) at 7 years follow up

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

24.3 Radial angulation (degrees)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

24.4 Ulnar variance (mm)

1

Mean Difference (IV, Fixed, 95% CI)

Not estimable

---

 25 Structural deformity

6

Risk Ratio (M-H, Fixed, 95% CI)

Subtotals only

---

25.1 Malunion (as defined by trialist)

2

198

Risk Ratio (M-H, Fixed, 95% CI)

0.58 [0.41, 0.81]

---

25.2 Malunion at 7 years follow up

1

86

Risk Ratio (M-H, Fixed, 95% CI)

0.96 [0.63, 1.47]

---

25.3 Carpal collapse

1

90

Risk Ratio (M-H, Fixed, 95% CI)

0.89 [0.55, 1.45]

---

25.4 Dorsal tilt increase due to "late collapse"

1

41

Risk Ratio (M-H, Fixed, 95% CI)

0.64 [0.23, 1.79]

---

25.5 Volar angulation of distal fragment

1

41

Risk Ratio (M-H, Fixed, 95% CI)

1.28 [0.29, 5.59]

---

25.6 Step-off >/= 2 mm (intra-articular alignment)

1

32

Risk Ratio (M-H, Fixed, 95% CI)

5.63 [0.29, 108.63]

---

25.7 Loss in position post-immobilisation

1

50

Risk Ratio (M-H, Fixed, 95% CI)

0.14 [0.01, 2.63]

---

25.8 Non-congruous joint surface for die-punch fractures

1

31

Risk Ratio (M-H, Fixed, 95% CI)

0.48 [0.24, 0.97]

---

 

Table 1. Definitions of key radiological parameters

---

Parameter	Definition	Normal 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 length	Distance 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 inclination	Angle 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 variance	Vertical 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

---

Items	Scores	Notes
(1) Was the assigned treatment adequately concealed prior to allocation?	Y = method did not allow disclosure of assignment. ? = small but possible chance of disclosure of assignment or unclear. N = 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)?	Y = withdrawals well described and accounted for in analysis. ? = withdrawals described and analysis not possible, or probably no withdrawals. N = no mention, inadequate mention, or obvious differences and no adjustment.
(3) Were the outcome assessors blinded to treatment status?	Y = effective action taken to blind assessors. ? = small or moderate chance of unblinding of assessors, or some blinding of outcomes attempted. N = not mentioned or not possible.
(4) Were important baseline characteristics reported and comparable?	Y = good comparability of groups, or confounding adjusted for in analysis. ? = confounding small, mentioned but not adjusted for, or comparability reported in text without confirmatory data. N = large potential for confounding, or not discussed.	Although many characteristics including hand dominance are important, the principal confounders are considered to be age, gender, type of fracture.
(5) Were the trial participants blind to assignment status after allocation?	Y = effective action taken to blind participants. ? = small or moderate chance of unblinding of participants. N = not possible, or not mentioned (unless double-blind), or possible but not done.
(6) Were the treatment providers blind to assignment status?	Y = effective action taken to blind treatment providers. ? = small or moderate chance of unblinding of treatment providers. N = not possible, or not mentioned (unless double-blind), or possible but not done.
(7) Were care programmes, other than the trial options, identical?	Y = care programmes clearly identical. ? = clear but trivial differences, or some evidence of comparability. N = not mentioned or clear and important differences in care programmes.	Examples of clinically important differences in other interventions are: time of intervention, duration of intervention, anaesthetic used within broad categories, operator experience, difference in rehabilitation.
(8) Were the inclusion and exclusion criteria for entry clearly defined?	Y = clearly defined (including type of fracture). ? = inadequately defined. N = not defined.
(9) Were the outcome measures used clearly defined?	Y = clearly defined. ? = inadequately defined. N = 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?	Y = optimal. ? = adequate. N = not defined, not adequate.
(11) Was the timing (e.g. duration of surveillance) clinically appropriate?	Y = optimal. (> 1 year) ? = adequate. (6 months - 1 year) N = not defined, not adequate. (< 6 months)

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Table 3. Categories of effectiveness (definitions)

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Rank	Category	Definition
1	Beneficial	Interventions for which effectiveness has been demonstrated by clear evidence from randomised controlled trials, and for which expectation of harms is small compared with the benefits.
2	Likely to be beneficial	Interventions for which effectiveness is less well established than for those listed under "beneficial".
3	Trade off between benefits and harms	Interventions for which clinicians and patients should weigh up the beneficial and harmful effects according to individual circumstances and priorities.
4	Unknown effectiveness	Interventions for which there is currently insufficient data or data of inadequate quality.
5	Unlikely to be beneficial	Interventions for which lack of effectiveness is less well established than for those listed under "likely to be ineffective or harmful"
6	Likely to be ineffective or harmful	Interventions for which ineffectiveness or harmfulness has been demonstrated by clear evidence.

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Table 4. Key characteristics of participants, fractures and interventions

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Study ID	Participants (N, gender, age)	Fracture Type/Classification	Timing of surgery/Reduction	Fixation	Conservative treatment
Abbaszadegan 1990	47; 77% female; mean age 63 years.	Displaced (5+ mm radial shortening); extra-articular and intra-articular. Colles'. Older 3 & 4.	After closed reduction and plaster cast for 1-3 days.	Skin incision for pins. Trans-articular fixation. External Hoffman fixator for 4 weeks.	Closed reduction and plaster cast for 4 weeks
Hegeman 2004	32; 91% female; mean age 70 years.	Displaced (> 10 degrees dorsal angulation and < 20 degrees radial inclination and > 3 mm positive ulnar variance) unstable intra-articular. AO C2 or C3.	Timing of intervention: not stated, but after X-ray examination. Reduction (probably closed).	No details of pin insertion. Trans-articular fixation. Hoffmann II compact external fixator for 6 weeks	Closed reduction and below elbow plaster cast for 6 weeks
Horne 1990	37; % female unknown; mean age 72 years.	Displaced extra-articular and intra-articular. (Colles' implied) Frykman 1, 2, 3, 4, 5 and 8.	Not stated but day care surgery after presentation to fracture clinic. Closed reduction.	Stab incision for pins. Trans-articular fixation. Modified AO tubular external fixator for 5 weeks.	Closed reduction and plaster cast for 5 weeks.
Howard 1989	50; % female unknown; mean age 47 years.	Severely displaced (30 degrees dorsal angulation / > 10 mm radial shortening) comminuted Colles' fracture. Intra-articular fractures included.	Not stated, usually next available trauma list. Reduction during external fixation.	"Careful" pin insertion. Trans-articular fixation. Medium-C-Hoffman external fixator for 5 to 6 weeks.	Closed reduction and below elbow plaster cast for 5 to 6 weeks.
Jenkins 1989	153; % female unknown; mean age 44 years.	Displaced. Extra-articular and intra-articular. Colles'. Frykman.	Probably closed reduction at fracture clinic. Operation on day of injury or following day.	Stab incision for pins. Non-bridging fixation (not across wrist joint). The distal wires transfixed the comminuted (if present) distal radial fragment. AO/ASIF external mini-fixator for 4 weeks.	Closed reduction and plaster cast for 4 weeks.
Kapoor 2000	61 of 90 in comparison; 25% female; mean age of whole trial group was 39 years.	Displaced (dorsal or volar). All intra-articular. Frykman (3, 4, 7 and 8) and AO.	Not stated, but acute injury treatment. No details of reduction method.	No details of pin insertion. Trans-articular fixation. Roger and Anderson external fixator, rigid frame, for 6 to 7 weeks.	Closed reduction and plaster cast for 6 to 7 weeks.
Kreder 2006	113; 65% female; mean age 53 years.	Displaced (but < 10 degrees dorsal tilt/angulation) with metaphyseal comminution (< 1/3rd of radius diameter). Extra-articular and intra-articular (stable congruous joint). AO A and C.	Not stated but within 1 week of injury. Closed reduction under regional anaesthesia.	Skin incision for insertion of pins into radial shaft. Trans-articular fixation. Small AO fixator for 6 to 8 weeks. Optional percutaneous K-wire fixation: removed 4 to 6 weeks.	Closed reduction and long arm splint for up to 2 weeks, then long arm cast which was reduced to a short arm cast at 3 to 4 weeks; removed 6 to 8 weeks.
Lagerstrom 1999	35; 86% female; mean age 58 years.	Displaced (10+ degrees dorsal angulation / radial angulation; 3+ mm radial shortening) intra-articular Colles' fracture. Frykman 5 to 8.	Not stated, but probably acute. No details of reduction method.	No details of pin insertion. Light (in weight) non-cylindrical AO external fixator for 6 weeks.	Below elbow plaster cast for 6 weeks.
McQueen 1996	90 of 120 in comparison; 90% female; mean age 64 years.	Redisplaced (> 10 degrees dorsal angulation or > 3 mm radial shortening). AO types A and C (extra-articular and intra-articular).	Within 2 weeks from injury. Closed reduction.	Open incisions for pin insertion. Trans-articular fixation. Pennig external fixator for 6 weeks. Ball joint released for limited wrist motion in 30 participants at 3 weeks.	Closed reduction and plaster cast for 6 weeks.
Pring 1988	75; 81% female; mean age 62 years.	Displaced Colles' fracture. Extra-articular and intra-articular.	After accident and emergency attendance and closed reduction using Chinese finger traps.	Percutaneous pin insertion. Trans-articular fixation. Pins incorporated into plaster cast. Cast removed after 5 weeks.	Closed reduction and forearm plaster cast for 5 weeks.
Rodriguez-Merchan 92	70; 17% female; mean age 36 years.	Comminuted intra-articular fractures. Frykman 3 to 8.	Probably closed reduction on first day after injury and operation then or next day.	Pins driven into bone. Trans-articular fixation. Clyburn dynamic external fixator for 7 weeks. Posterior splint applied for 3 weeks if joint disrupted. Optional K wire inserted for 3 weeks if joint unstable.	Closed reduction and forearm plaster cast for 7 weeks.
Rouman 1991	43; % female unknown; age over 55 years.	Redisplaced Colles' fracture (>10 degrees dorsal angulation or > 5 mm radial shortening). All intra-articular. Frykman (5 to 8) and Sarmiento.	At 2 weeks. Closed reduction.	No details of pin insertion. Trans-articular fixation. Ace Colles external fixator for 5 weeks.	Plaster cast continued for 5 weeks.
Stein 1990	62; % female unknown; mean age 50 years.	Comminuted displaced intra-articular fractures. Older 3 and 4 (thus Colles').	Not stated but after presentation to fracture clinic. Admission to hospital for 24 hours or day care facility for surgery. Closed reduction.	No details of pin insertion. Trans-articular fixation likely. "Small" AO external tubular fixator for 6 weeks.	Closed reduction and above-elbow plaster cast for 6 weeks.
Young 2002	125; 78% female; mean age 57 years.	Displaced (> 10 degrees dorsal angulation or > 2 mm radial shortening) distal radial fractures. Extra-articular and intra-articular. Colles'. Frykman: all grades (1-8).	Not stated. Closed reduction. Hospital admission for external fixation.	Percutaneous pin insertion for 2nd metacarpal, direct vision for insertion into radial shaft. Trans-articular fixation. Pennig external fixator for 6 weeks. Ball joint released for limited wrist motion at 3 weeks.	Closed reduction and forearm plaster cast for 6 weeks.
Zheng 2003	29; 48% female, range 18 - 52 years	Closed unstable distal radial fracture. Universal classification (Cooney) 2B, 2C (extra-articular), 4B, 4C (intra-articular).	Not stated. Closed or open reduction. Participants were either outpatients or inpatients.	Pins inserted through skin incisions. Trans-articular fixation. Small size Zhongjia SGD-type unilateral multifunctional external fixator. Optional Kirschner wire for unstable fractures. Fixator made dynamic and K-wire removed from week 4. Fixator removed after 6 weeks.	Closed reduction and forearm plaster cast for 6 weeks.

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Table 5. Quality assessment results for individual trials (see Table 03 for scheme)

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Study ID	Items and grades	Items and grades	Items and grades	Notes
Study ID	Item 1: Allocation concealment Item 2: Intention-to-treat analysis Item 3: Outcome assessor blinding Item 4: Comparable baseline characteristics	Item 5: Participant blinding Item 6: Treatment provider blinding Item 7: Identical care programmes Item 8: Clearly defined inclusion criteria	Item 9: Well defined outcome measures Item 10: Optimal outcome assessment Item 11: Optimal timing of follow up (> 1 year) In brackets: date of last follow up; % lost to last follow up	Comments and explanations for specific items
Abbaszadegan 1990	?, Y, N, N	N, N, N, Y	Y, ?, ? (1 year; 2%)	Item 4: separate age, sex and type of fracture data not provided.
Hegeman 2004	?, Y, N, Y	N, N, ?, Y	Y, ?, ? (1 year; 0%?)	Item 7: method(s) of anaesthesia not given.
Horne 1991	?, N, N, N	N, N, ?, ?	Y, N, N (4 - 15 months; 22%)	Item 2: discrepancies in numbers followed up in the two groups. Item 4: baseline data not provided for all participants.
Howard 1989	?, Y, N, ?	N, N, Y, Y	Y, ?, Y (10 years; 20% or 22%)	Item 2: although "Y" there were some data discrepancies between the two abstracts reporting the long-term follow up.
Jenkins 1989	N, ?, N, N	N, N, N, ?	Y, ?, Y (13 months; 19%)	Item 4: There was a 10 year difference in the mean ages of the two groups (38 versus 48). Item 8: The maximum age differed between 65 in the Masters thesis and 60 in the 2 journal publications.
Kapoor 2000	?, N, N, ?	N, N, N, ?	Y, ?, Y (mean 4 years; 33%)	Item 2: no mention of loss to follow up but fewer participants in the analyses at 4 years.
Kreder 2006	Y, Y, N, Y	N, N, ?, Y	Y, Y, Y (2 years; 25%)	Item 7: regional aneasthesia was used in the external fixation group and haematoma block in the plaster group.
Lagerstrom 1999	?, ?, N, N	N, N, Y, Y	Y, ?, Y (2 years; 6%)	Item 4: key patient characteristics were not split by group except for gender. There were males (5/18) in the external fixation group but none (0/17) in the plaster group.
McQueen 1996	?, Y, N, ?	N, N, ?, Y	Y, ?, ? (1 year; 9%)
Pring 1988	?, N, N, ?	N, N, ?, N	Y, ?, ? (6 months; 12%)	Item 2: 9 people from the plaster group were given external fixation and reportedly analysed separately but no data were given.
Rodriguez-Merchan 92	?, ?, N, ?	N, N, ?, Y	Y, ?, ? (1 year; 0%?)	Item 1: though described as "double-blind", no details were given of the method of randomisation.
Roumen 1991	?, N, N, N	N, N, N, Y	Y, ?, ? (6 months; 0%?)	Item 2: It is possible that some patients who were lost to follow up (17) or had died (2) from the initial group of 126 people with displaced fractures would have be included in the trial should their fractures have redisplaced.
Stein 1990	N, ?, N, N	N, N, N, Y	?, N, ? (6 months to 4 years; 0%?)	Item 10: The final follow up of participants, recruited over a 4 year period, ranged from 6 months to 4 years.
Young 2003	?, Y, N, ?	N, N, ?, Y	Y, ?, Y (7 years; 31%)
Zheng 2003	N, ?, N, N	N, N, ?, ?	Y, ?, ? (1 year; 0%?)	Item 4: Insufficient information but also imbalance in number of males (5 versus 10).

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Table 6. Category of effectiveness for external fixation versus conservative treatment

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Comparison	Category	Justification	Qualifiers	Comments
External fixation (EF) versus conservative treatment	3: Trade off between benefits and harms	EF reduces redisplacement requiring secondary treatment (usually remanipulation under anaesthesia in the plaster cast group) and yields better anatomical results. However, the evidence of a better functional outcome from EF is weak. Moreover, EF is associated with a high risk of complications. Pin site infection, while common, is generally resolvable with local treatment. Other complications, such as superficial radial nerve paraesthesia, are less common but often more serious.	(1) Indications (especially fracture types) for treatment; and type, technique and timing of EF not resolved. (2) Incomplete functional and long term outcome. (3) Heterogeneous interventions, patient characteristics. (4) Compromised methods of several trials means that serious bias cannot be ruled out.	Minimal details were usually provided for the conservative treatment intervention which always involved plaster cast immobilisation. There remains a possibility of suboptimal application of plaster casts in some trials. Some EF techniques were not optimal - increased risk of iatrogenic complications.

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