Rheumatoid Arthritis Clinical Trial
Official title:
Prospective, Multicenter, Observational, Comparative Clinical Trial on the Equivalence of Two Different OrthoPilot® Navigation System Generations Applied for Computer-assisted Total Knee Arthroplasty
Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty
The study is designed as a prospective, non-interventional, multicenter, comparative cohort study. The product under investigation will be used in routine clinical practice and according to the authorized Instructions for Use (IfU). Those data that are obtained in routine clinical use will be documented in the Case Report Form (CRF). The study design is based on a two-arms design. The patients for the both groups will be recruited consecutively, starting with group A. The study will prove the equivalence of the groups regarding the outcome of the postoperative lower limb alignment (mechanical leg axis) and any deviation >3° from neutral alignment is defined as an outlier. ;
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