Jacobs 2011.
Methods | RCT, multi‐centre Computer‐generated block‐stratified randomisation Duration of the study: 1 year |
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Participants | Inclusion: patient diagnosed with osteoarthritis; candidate for primary TKA; expected to undergo only 1 arthroplasty procedure within next 12 months; 60–75 years old; preoperative alignment (varus or valgus) < 10 °; BMI < 30; lives independently Exclusion: missing/insufficient PCL The Netherlands/Switzerland: 92 participants Fixed: n = 46, 32 female, age 67.6 (± 4.4) years Mobile: n = 46, 33 female, age 66.7 (± 4.6) years |
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Interventions | Fixed: balanSysTM type (Mathys Medical Ltd) Mobile: balanSysTM type (Mathys Medical Ltd) No patellar resurfacing Tibia and femur components cemented |
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Outcomes | Active flexion, KSS function, KSS clinical Assessments: preoperative and at 3 months, 6 months and 12 months Average and standard deviation given |
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Notes | Funded by Mathys Medical Ltd 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 block‐stratified randomisation |
Allocation concealment (selection bias) | Low risk | Closed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participant blinded; surgeon not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No blinding attempted at any of the assessments |
Incomplete outcome data (attrition bias) All outcomes | High risk | 1 centre with 30 participants was excluded from analysis because of randomisation error; no intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Protocol available and prespecified outcomes reported |
Other bias | Low risk | Homogeneity in participant groups on prognostic factors; co‐interventions described in sufficient detail |