RecruitingNCT04462458

M-ARS ACL Post-marketing Surveillance Study

Clinical and Radiological Outcomes of M-ARS ACL


Sponsor

Medacta International SA

Enrollment

200 participants

Start Date

Jul 1, 2022

Study Type

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

Min Age: 18 Years

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

DEVICEMedacta Anatomic Ribbon Surgery (M-ARS ACL)

M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique


Locations(3)

Praxis Gelenkpunkt - Sport- und Gelenkchirurgie

Innsbruck, Austria

Pyhrn-Eisenwurzen Klinikum Kirchdorf

Kirchdorf an der Krems, Austria

OCM Klinik GmbH

München, Germany

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NCT04462458


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