Kim 2009a.
Methods | RCT stated Randomisation technique not stated Duration of study: 2.6 years | |
Participants | Inclusion: bilateral cases with degenerative osteoarthritis with prior non‐operative therapy
Exclusion: rheumatoid arthritis, septic arthritis history Korea: 92 participants (184 knees) 85 female, 7 male, age 69.5 (± 7.92) years |
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Interventions | Fixed: Medial Pivot (Wright Medical) Mobile: PFC Sigma, rotating platform (DePuy) Routine patellar resurfacing All components cemented Flexion space with various bone referenced techniques | |
Outcomes | KSS, HSS, range of motion, satisfaction Only final follow‐up (2.6 years) given Point estimates and ranges given | |
Notes | No commercial association of any of the study authors Study authors reported no conflict of interest |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised allocation |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
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 | Unclear risk | Outcome assessor blinding unclear |
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 |