Kim 2007.
Methods | RCT stated Randomisation based on sequential pool derived from a table of randomised numbers Duration of study: 5.6 years | |
Participants | Inclusion and exclusion criteria not described
Selection yielded bilateral procedures on 173 patients with osteoarthritis and on 1 patient with rheumatoid arthritis
Korea: 174 patients (348 knees) 112 female, 62 male, age 67 (45‐85) years |
|
Interventions | Fixed: PFC Sigma (DePuy)
Mobile: PFC Sigma, rotating platform (DePuy)
Routine patellar resurfacing
All components cemented Flexion space with bone resection |
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Outcomes | KSS, HSS, alignment, component positions, radiolucent lines, lateral patellar tilt Only final, long‐term outcome (5.6 years) given Point estimates and ranges given | |
Notes | No benefits received from any commercial party No declarations of interest reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sequential pool based on a table of randomised numbers |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Participant blinding not described; surgeon not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessor blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Drop‐out rate given and acceptable; no intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | Low risk | Homogeneity in participant groups on prognostic factors; co‐interventions described in sufficient detail |