Status:
RECRUITING
M-ARS ACL Post-marketing Surveillance Study
Lead Sponsor:
Medacta International SA
Conditions:
Anterior Cruciate Ligament (ACL) Reconstruction
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this study is to evaluate the performance of Medacta Anatomic Ribbon Surgery (M-ARS) in patients requiring anterior cruciate ligament (ACL) reconstruction. The main goal is to evaluate th...
Detailed Description
This s a prospective, multicenter, non-controlled, observational study to evaluate the outcomes of Medacta Anatomic Ribbon Surgery (M-ARS) in the reconstruction of the anterior cruciate ligament (ACL)...
Eligibility Criteria
Inclusion
- Patients older than 18 years
- Patients with ACL rupture requiring ACL reconstruction
Exclusion
- Patients with malignant diseases (at the time of surgery)
- Patients with proven or suspected infections (at the time of surgery)
- Patients with functional deficits of the affected extremity (at the time of surgery)
- Patients with known incompatibility or allergy to products materials (at the time of surgery)
Key Trial Info
Start Date :
July 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04462458
Start Date
July 1 2022
End Date
January 1 2027
Last Update
March 13 2023
Active Locations (3)
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1
Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
Innsbruck, Austria, 6020
2
Pyhrn-Eisenwurzen Klinikum Kirchdorf
Kirchdorf an der Krems, Austria, 4560
3
OCM Klinik GmbH
München, Germany, 81369