Gleeson 1996.

Methods	Randomised controlled trial (parallel)
Participants	51 children Setting and recruitment period: Booth Hall Children's Hospital between February and May 1994 Inclusion criteria: Children with swelling after an inversion injury to the ankle and tenderness over lateral malleolus, normal ankle radiograph with no evidence of growth‐plate fusion, and who were unable to, or who could only partially, weight bear Exclusion criteria: Fracture or other abnormality noted on radiograph Evidence of growth‐plate fusion Able to fully weight bear Gender (of 45): 26 females, 19 males Age (of 45): mean 9.2 years, range 3 to 14 years Fracture type: An ultrasound of the ankle was performed in 40 children within 72 hours of presentation to determine injury to the growth plate. Various anomalities were reported: soft‐tissue swelling, subperiosteal haematoma, swelling of peroneus longus, venous congestion, joint effusion, metaphyseal irregularity, which suggested undisplaced Salter‐Harris I growth‐plate injuries. Of the 34 children with ultrasound results at follow‐up, 19 had "definite evidence of growth‐plate injury" (subperiosteal haematoma)
Interventions	Tubigrip (Seton Healthcare PLC) and crutches, with advice to manage at home with the application of ice and elevation of the limb (easily removable for bathing) Weight‐bearing plaster of Paris cast for 2 weeks Allocation: 51 in all Analysed: 24 (Tubigrip); 21 (cast)
Outcomes	Follow‐up schedule: After 2 weeks and 4 weeks Primary outcome: Time to return to normal activities Secondary outcome: Assessment score (3 to 17; higher scores = worse outcome) documenting pain (visual analogue score 0 to 5), swelling (1 to 4), tenderness over lateral malleolus (1 to 4) and degree of weight‐bearing (1 to 4)
Notes	The inclusion criteria corresponded to an assessment score of ≥ 10
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Authors stated "After initial assessment were randomly allocated ..." but gave no further details regarding method of randomisation
Allocation concealment (selection bias)	Unclear risk	Authors stated "After initial assessment were randomly allocated ..." but gave no further details regarding method of randomisation or measures to ensure allocation concealment
Blinding of participants and personnel (performance bias) Patient‐rated outcomes	High risk	Blinding of children and personnel to the allocated intervention was not feasible
Blinding of participants and personnel (performance bias) Clinician‐rated outcomes	High risk	Blinding of children and personnel to the allocated intervention was not feasible
Blinding of outcome assessment (detection bias) Patient‐rated outcomes	High risk	No blinding of children was noted in the study, thus patient‐reported outcomes are at high risk of bias
Blinding of outcome assessment (detection bias) Clinician‐rated outcomes	High risk	No blinding of the assessors was noted in the study, thus personnel‐reported outcomes are at high risk of bias
Incomplete outcome data (attrition bias) Patient‐rated outcomes	High risk	Group allocation not provided for 6 children lost to follow‐up (12% of 51). Of the 51 children initially recruited, 6 were lost to follow‐up. Of the remaining 45 who completed the study, 34 had ultrasound scans. The incomplete data may be a source of bias
Incomplete outcome data (attrition bias) Clinician‐rated outcomes	High risk	Group allocation not provided for 6 children lost to follow‐up (12% of 51). Of the 51 children initially recruited, 6 were lost to follow‐up. Of the remaining 45 who completed the study, 34 had ultrasound scans. The incomplete data may be a source of bias
Selective reporting (reporting bias)	High risk	No protocol available. It seems likely that the analyses relating to ultrasound findings were post‐hoc. Incomplete description of outcome measurement in methods. No report of adverse effects
Other bias	Unclear risk	No sample size calculation provided

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