| Methods |
RCT; computer‐generated block randomisation |
| Participants |
Unicompartmental knee OA: n = 117
Male/ female: 69/48
Mean age (years): 59
Mean BMI (kg/m2): 28.5
Varus: n = 95/valgus: n = 22
Mean varus (degrees) = 188
Mean valgus (degrees) = 173 |
| Interventions |
I = Brace intended to reduce load (n = 60) vs C = standard conservative treatment (n = 57)
Follow‐up: 12 months |
| Outcomes |
VAS, HSS knee score, walking distance, EuroQol |
| Notes |
No competing interests |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "patients were randomised according to a computer‐generated procedure in blocks of 24" |
| Allocation concealment (selection bias) |
Low risk |
Quote: "the allocation of treatment was concealed until after the patient was included and baseline measurements were executed; sealed envelopes contained the group assignment" |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Outcome assessor of the HSS knee was blinded for allocation |
| Blinding of participants and personnel (performance bias)
All outcomes |
High risk |
Participants were not blinded; outcome assessor of the HSS knee was blinded |
| Blinding of outcome assessment (detection bias)
All outcomes |
High risk |
Study used patient‐reported outcome measures; participants were not blinded. Functional outcome (HSS knee score) was measured blinded |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Intention‐to‐treat |
| Selective reporting (reporting bias) |
Low risk |
Complete data were reported |
