Kim 2009b.
Methods | RCT stated Randomisation based on sequential pool derived from a table of randomised numbers Duration of study: 10‐12 years |
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Participants | Inclusion: patients younger than 55 requiring bilateral TKA Exclusion: criteria not mentioned Korea: 61 participants (122 knees) 45 female, 16 male, age 48.3 (34‐55) years |
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Interventions | Fixed: AMK (DePuy) Mobile: LCS, meniscal bearing (DePuy) Routine patellar resurfacing All components cemented |
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Outcomes | KSS total, KSS functional, KSS pain, ROM, HSS total, HSS pain, alignment, radiolucent lines Assessments preoperative and at final follow‐up 10 to 12 years postoperative Average given |
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Notes | No benefits or funds received in support of the study 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 | Observer blinded for radiographic findings |
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 |