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. 2015 Feb 4;2015(2):CD003130. doi: 10.1002/14651858.CD003130.pub3

Jacobs 2011.

Methods RCT, multi‐centre
Computer‐generated block‐stratified randomisation
Duration of the study: 1 year
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
Interventions Fixed: balanSysTM type (Mathys Medical Ltd)
Mobile: balanSysTM type (Mathys Medical Ltd)
No patellar resurfacing
Tibia and femur components cemented
Outcomes Active flexion, KSS function, KSS clinical
Assessments: preoperative and at 3 months, 6 months and 12 months
Average and standard deviation given
Notes Funded by Mathys Medical Ltd
No declarations of interest reported
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