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ACL Reconstruction with a New Generation of LARS Artificial Ligament

StatusActive, Not Recruiting
PhaseNot applicable
SponsorMOVMEDIX
Started
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Record History

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  1. Secondary endpoints: details revised at 3 of 6 entries
    • Eligibility criteria expanded, about 1 word
    v2
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
MOVMEDIX
2 trials monitored
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This clinical investigation is intended to demonstrate the safety of the new generation of LARS ligaments and compare this new generation (grafted ligament) of artificial ligament to the LARS current artificial ligament (non-grafted ligament) which is CE marked since 1997, in case of ACL injury. The new generation of LARS artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation, fibroblast organization and collagen type I \& III secretion. This physiological response leads to a better osseo-integration of the ligaments. Therefore, the study is expected to demonstrate the investigational device safety and biomechanical improvements.
Trial Details
NCT Number NCT06571955
Lead Sponsor MOVMEDIX
Conditions
(from sponsor)		 ACL Injury
Related terms Anterior Cruciate Ligament Injuries
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov