Clinical Trial

M-ARS ACL Post-marketing Surveillance Study

Recruiting
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Record status
This record was last updated March 13, 2023 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2020-07-02; most recent amendment 2023-03-10.
Status change: Not Yet Recruiting → Recruiting 2021-02-26
Trial Details
NCT Number NCT04462458
Lead Sponsor Medacta International SA
Conditions Anterior Cruciate Ligament (ACL) Reconstruction
Enrollment 200 participants
Start Date 2022-07-01
Primary Completion 2025-07 (estimated)
Study Completion 2027-01 (estimated)
Updated on ClinicalTrials.gov 2023-03-13