Methods |
RCT; computer‐generated blocked randomisation scheme with use of sealed envelopes; blinding of outcome assessment not described |
Participants |
Varus arthrosis: n = 119
Male/female: 79/31
Mean age (years): 59
Mean varus (degrees): 189 |
Interventions |
I = unloader brace (n = 41) vs C1 = neoprene brace (n = 36) vs C2 = medical treatment only (n = 33)
Follow‐up: 6 months |
Outcomes |
WOMAC and MACTAR scores
Function assessed with use of the 6‐minute walking and the 30‐second stair climbing test |
Notes |
No competing interests |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Quote: "a computer‐generated blocked randomisation scheme" |
Allocation concealment (selection bias) |
Low risk |
Quote: "with use of sealed envelopes" |
Blinding (performance bias and detection bias)
All outcomes |
High risk |
Participants were not blinded to the intervention |
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 |
Study used patient‐reported outcomes. Outcome assessor of patient‐reported outcome measures was not blinded |
Incomplete outcome data (attrition bias)
All outcomes |
High risk |
No intention‐to‐treat analysis |
Selective reporting (reporting bias) |
Low risk |
Complete data were reported |