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 |