M-ARS ACL Post-marketing Surveillance Study
Clinical and Radiological Outcomes of M-ARS ACL
Medacta International SA
200 participants
Jul 1, 2022
OBSERVATIONAL
Conditions
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 the survival rate of M-ARS ACL at 6 months post-operatively. The secondary goals are to assess the survival rate, clinical and functional outcomes, the quality of life, and the rate of complications at 1 month, 1 year and 2 years post-operatively.
Eligibility
Inclusion Criteria2
- Patients older than 18 years
- Patients with ACL rupture requiring ACL reconstruction
Exclusion Criteria4
- 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)
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Interventions
M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT04462458