Lizaur‐Utrilla 2012.
Methods | RCT Randomisation based on computer‐generated random numbers table Duration of the study: 2.5 years |
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Participants | Inclusion: osteoarthritic patients with primary TKA, aged 70 years or older, without prior infection in the knee and with severe angular deformity or severe instability that required grafting, modular augmentation or a constrained design Spain: 119 participants Fixed: n = 58, 47 female, age 73.9 (± 3.2) years Mobile: n = 61, 47 female, age 74.6 (± 3.3) years |
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Interventions | Fixed: Trekking MB (Samo) Mobile: Multigen Plus FB (Lima) Patella resurfaced if there was degeneration Cementless femoral component design and a cemented tibial component |
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Outcomes | Maximum knee flexion assessments preoperative and at 3 months, 6 months, 12 months and 24 months KSS function, WOMAC, SF‐12, VAS, radiolucent lines assessments preoperative and at 3 months, 6 months and 12 months, and yearly thereafter, but only final follow‐up results given Average, standard deviation and range given |
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Notes | No funding stated 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) | Low risk | Computer‐generated random number tables |
Allocation concealment (selection bias) | Low risk | Office staff |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participant blinded; surgeon not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Observers blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Drop‐out rate given and acceptable; 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 |