NCT03817632

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 217 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multicenter, observational, comparative clinical trial on the equivalence of two different OrthoPilot® navigation system generations applied for computer-assisted total knee arthroplasty

Detailed description

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.

Conditions

• Degenerative Osteoarthritis
• Rheumatoid Arthritis
• Posttraumatic Arthropathy
• Instability, Joint
• Stiffness of Knee, Not Elsewhere Classified
• Deformity of Knee

Interventions

Type	Name	Description
DEVICE	Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1	Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
DEVICE	Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0	Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0

Timeline

• Start date: 2019-07-01
• Primary completion: 2022-06-30
• Completion: 2022-10-29
• First posted: 2019-01-25
• Last updated: 2023-01-17

Locations

3 sites across 1 country: Germany