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M-ARS ACL Post-marketing Surveillance Study

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Notable Start date changed from estimate of Sep 1, 2021 to Jul 1, 2022 Completion date: Dec 2025 to Jan 2027v8 Show 1 more changeShow less
    • Completion date: Dec 2025 to Jan 2027
  2. Minor Study sites: 2 to 3v7
  3. Notable Start date: Jul 1, 2021 to Sep 1, 2021v6
  4. Minor Study sites: 1 to 2v5
  5. Notable Start date: May 1, 2021 to Jul 1, 2021v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Start date: Mar 1, 2021 to May 1, 2021v3
  2. Notable Trial status: Not Yet Recruiting to Recruiting Primary completion date: Jul 2024 to Jul 2025 · Start date: Jul 1, 2020 to Mar 1, 2021 · Completion date: Dec 2024 to Dec 2025 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Jul 2024 to Jul 2025
    • Start date: Jul 1, 2020 to Mar 1, 2021
    • Completion date: Dec 2024 to Dec 2025
    • Site details revised
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04462458
Lead Sponsor Medacta International SA
Conditions Anterior Cruciate Ligament (ACL) Reconstruction
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov