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M-ARS ACL Post-marketing Surveillance Study

NCT04462458 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-03-13

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament (ACL) Reconstruction

Interventions

DEVICE

Medacta Anatomic Ribbon Surgery (M-ARS ACL)

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

Sponsors & Collaborators

  • Medacta International SA

    lead INDUSTRY

Principal Investigators

  • Mirco Herbort, Prof. Dr. med. · OCM Klinik GmbH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2025-07-31
Completion
2027-01-31

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04462458 on ClinicalTrials.gov