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. 2018 Dec 19;2018(12):CD012470. doi: 10.1002/14651858.CD012470.pub2

McLauchlan 2002.

Methods Randomised trial
Study period: May 1997 to October 1999
Participants Royal Hospital for Sick Children, Edinburgh, UK
 68 with completely displaced metaphyseal fractures of the distal radius, with of without ulnar fracture
 Exclusion: physeal injuries
 Sex: 42 male (62%)
 Age: mean 7.9 years, range 4 to 14 years
Fracture type: both bones 60; "intact ulna" 8; 1 grade 1 open injury
 Assigned: 35 (wire) / 33 (cast only)
 Analysed: 34 / 31 (radiological review); 56 for clinical review (3 months) (see Notes)
Interventions Reduction under general anaesthesia within 18 hours of admission, checked with image intensifier
1. Single percutaneous Kirschner wire introduced across the fracture to the radial side of Lister's tubercule. Then above‐elbow cast (probably plaster). Review at 3 weeks when wire removed and cast changed
 2. Above‐elbow cast (probably plaster). Weekly radiological review for 3 weeks
Casts removed between 4 and 6 weeks after injury, depending on age of child
Outcomes Length of follow‐up: 3 months, also 3 weeks, and 4 to 6 weeks (at cast removal)
Functional deficit
Loss of position and secondary procedure
Pain requiring early wire removal
Prominant scarring
Wire migration
Malunion
 Residual pain
Grip strength
 Range of motion (flexion, extension, radial and ulnar deviation, supination, pronation)
 Angular deformity
Funding and declarations of interest Funding source: not stated
Declarations of interest: not stated
Notes Paper did not provide the numbers of participants in the 2 groups available for clinical review
 Corrective osteotomy was performed at 6 months in 1 participant of the cast‐only group
 Small discrepancies between abstract and full reports of the trial
 7 children whose parents refused consent for trial inclusion were treated conservatively
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No description of sequence generation
Allocation concealment (selection bias) Unclear risk Quote: “A sealed envelope was then opened to determine whether it was to be managed in a long‐arm cast alone or with an additional single percutaneous K‐wire.” (Opened after closed reduction)
Insufficient information
Blinding of participants and personnel (performance bias) 
 Subjective outcomes High risk Not blinded. Obvious differences in the 2 groups
Blinding of participants and personnel (performance bias) 
 Objective outcomes High risk Not blinded. Obvious differences in the 2 groups
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Quote: “At three months after injury assessment of the function of the wrist was carried out independently by the same physiotherapist (BC) to avoid interobserver error.”
Quote: “Final radiographs, taken at the time of clinical assessment, were evaluated by one surgeon.”
Blinding of outcome assessment (detection bias) 
 Objective outcomes High risk Not blinded. Including interim assessment of deformity
Incomplete outcome data (attrition bias) 
 Subjective outcomes Unclear risk 56 returned for clinical review. The allocation of the 12 (18%) lost to follow‐up was not stated
Paper did not provide the numbers of participants in the 2 groups available for clinical review
Incomplete outcome data (attrition bias) 
 Objective outcomes High risk 56 returned for clinical review. The allocation of the 12 (18%) lost to follow‐up was not stated Additionally, radiological records were incomplete in 3 records – these were probably in addition to the 12 already missing from follow‐up
Selective reporting (reporting bias) Unclear risk No published protocol or trial registration. Small discrepancies between abstract and full report (e.g. 8 cast‐only required a second procedure to correct deformity compared with 7 in full report) Incomplete reporting on function
Other bias: major imbalance in baseline characteristics Unclear risk Insufficiently reported
Other bias: performance bias Unclear risk After enrolment “the patient was under the care of one of four consultations and any further management followed the consultant’s normal practice.”
Other bias Low risk No other sources of bias identified