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. 2015 Mar 16;2015(3):CD004020. doi: 10.1002/14651858.CD004020.pub3

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
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
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