Tibesku 2011.
Methods | RCT stated Randomisation based on computer‐generated list Duration of study: 2 years |
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Participants | Inclusion: 50‐80 years, unilateral primary osteoarthritis, absence of mediolateral instability, deviation of the long leg axis of less than 10° Exclusion: any co‐morbidity that negatively influenced gait Germany: 33 participants Fixed: n = 17, 12 female, age 66 (± 10) years Mobile: n = 16, 9 female, age 65 (± 9) years |
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Interventions | Fixed: Genesis II (Smith and Nephew) Mobile: Genesis II, meniscal bearing (Smith and Nephew) No patellar resurfacing Cementing unclear |
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Outcomes | Flexion, KSS, HSS, SF‐36, Tegner, UCLA, VAS pain, gait analysis Assessments preoperative and at final follow‐up 24 months postoperative Average and standard deviation given |
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Notes | No funding stated 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 | Computer‐generated list |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participant blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Observer blinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | No description of withdrawals and dropouts; no intention‐to‐treat analysis |
Selective reporting (reporting bias) | Unclear risk | No protocol available |
Other bias | High risk | No homogeneity in participant groups on prognostic factors; no subgroups given that are homogeneous; co‐interventions not described in sufficient detail |