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M-ARS ACL Post-marketing Surveillance Study

Recruitingn/aAges 18 Years - anyAllMedacta International SA
NCT04462458 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients older than 18 years * Patients with ACL rupture requiring ACL reconstruction Exclusion Criteria: * 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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What it tests

  • Medacta Anatomic Ribbon Surgery (M-ARS ACL)
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Where

3 sites
Praxis Gelenkpunkt - Sport- und Gelenkchirurgie
Innsbruck, Austria
Pyhrn-Eisenwurzen Klinikum Kirchdorf
Kirchdorf an der Krems, Austria
OCM Klinik GmbH
München, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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