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

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