M-ARS ACL Post-marketing Surveillance Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMedacta International SA
About this trial
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 criteria
Qualifiers
Patients older than 18 years
Patients with ACL rupture requiring ACL reconstruction
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Medacta Anatomic Ribbon Surgery (M-ARS ACL)
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov