Raaij van 2010.
Methods | RCT; computer‐generated blocked randomisation | |
Participants | Medial knee OA: n = 91
Male/female: 46/45
Mean age (years): 55
Mean BMI (kg/m2): 29
Mean varus (degrees) = 187 Degree of medial OA according to Kellgren & Lawrence (n): I = 37, II = 17, III = 35, IV = 2 Degree of lateral OA according to Kellgren & Lawrence (n): 0 = 67, I = 22, II = 2 |
|
Interventions | I = 10‐mm laterally full‐length wedged insole (n = 45) vs C = valgus brace (n = 46) | |
Outcomes | VAS (pain), WOMAC, degree of varus (hip‐knee‐ankle angle) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "participants were randomised according to a computer‐generated procedure (block randomisation, with variable sizes of the blocks)" |
Allocation concealment (selection bias) | Low risk | Quote: "the randomizations codes were held by an independent observer to ensure masked blocking" |
Blinding (performance bias and detection bias) All outcomes | High risk | Unblinded trial |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "completely unblinded" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "one non‐blinded investigator, a trained orthopedic surgeon, assessed the follow‐up measurements" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "by intention‐to‐treat" |
Selective reporting (reporting bias) | Low risk | Complete data were reported |