Status:
COMPLETED
Orthopilot Elite Post-Market Clinical Follow-Up
Lead Sponsor:
Aesculap AG
Conditions:
Degenerative Osteoarthritis
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Brief 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 author...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 29 2022
Estimated Enrollment :
217 Patients enrolled
Trial Details
Trial ID
NCT03817632
Start Date
July 1 2019
End Date
October 29 2022
Last Update
January 17 2023
Active Locations (3)
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1
Universitätsklinikum Carl Gustav Carus
Dresden, Germany, 01307
2
Uniklinikum Freiburg
Freiburg im Breisgau, Germany, 79106
3
Schönkliniken Klinikum Eilbek
Hamburg, Germany, 22081