Sattari 2011.
Methods | RCT; computer‐generated randomisation | |
Participants | Varus knee OA: n = 60 Male/female: 22/38 Mean age (years): 48 Mean BMI (kg/m2): not reported Degree of OA medial compartment according to Kellgren & Lawrence: III = 39, IV = 21 |
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Interventions | I = custom‐molded valgus stress knee support (n = 20) or 1/4‐inch lateral wedged insole (n = 20) vs C = no intervention Follow‐up: 9 months |
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Outcomes | VAS (pain), Lequesne index (walking distance) | |
Notes | Conflicts of interest are not described | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation sequence procedure is not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment procedure is not described |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants were not blinded; outcome assessors were blinded; study used patient‐reported outcome measures |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "5 patients were removed from the study because of absence from follow‐up. They were substituted with new patients, to maintain 20 patients in each group" |
Selective reporting (reporting bias) | High risk | No intention‐to‐treat |