Orthopilot Elite Post-Market Clinical Follow-Up

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.

Inclusion: Inclusion Criteria:

• Patients with indication for Total Knee Arthroplasty using the Aesculap OrthoPilot® navigation system and a corresponding primary implant
• Dated and signed informed consent

Exclusion: Exclusion Criteria

• Pregnancy
• Patients < 18 years
• Patients unable to participate at the follow-up examination (physically, mentally)
• Previous joint replacement at the indexed knee