Henricson 2006.
Methods | RCT stated Randomisation based on sealed envelopes opened during surgery Duration of study: 2 years | |
Participants | Inclusion: primary gonarthrosis grade III‐IV; age between 60 and 85 years; body weight < 120 kg; no gonarthrosis secondary to arthritis or trauma; no previous knee surgery
Sweden: 47 participants (52 knees) Fixed: n = 26, 14 female, age 72 (62‐83) years Mobile: n = 26, 16 female, age 72 (62‐84) years |
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Interventions | Fixed: NexGen (Zimmer)
Mobile: MBK, meniscal bearing (Zimmer) Some participants with patellar component All components cemented |
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Outcomes | RSA, KSS, HSS Assessments: preoperative and at 3, 12 and 24 months Average, range or 95% CI given | |
Notes | One of the study authors received funding from Zimmer Scandinavica | |
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 opened during operation |
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 not described |
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 |