Erhart‐Hledik 2012.
| Methods | RCT; randomisation procedure not described; outcome assessment partially blinded | |
| Participants | Medial compartment knee OA: n = 79 Male/female: 42/37 Mean age (years): 60 Mean BMI (kg/m2): 27.7 | |
| Interventions | I = Variable‐stifness shoe (n = 40) vs C = constant stiffness shoe (n = 39) Follow‐up = 6 and 12 months |
|
| Outcomes | WOMAC | |
| Notes | 6‐Month results were presented earlier. Patients were included on the basis of MRI. Anteroposterior radiograph was used during follow‐up | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "using a random number generator" |
| Allocation concealment (selection bias) | Low risk | Quote: "The randomization code was revealed to the study coordinator in charge of subject recruitment and in contact with the subjects regarding WOMAC scores, once recruitment, data collection, and analyses were completed" |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Subjects were blinded to their shoe type" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Subjects were blinded to their shoe type (The researcher performing the gait analysis was not blinded to the shoe type)" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Subjects were blinded to their shoe type" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat |
| Selective reporting (reporting bias) | Low risk | Complete data were reported; study author provided additional data for this review |