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Recruiting NCT06357091

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

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Trial Parameters

Condition Anterior Cruciate Ligament Rupture
Sponsor Alexander Rofner-Moretti
Study Type INTERVENTIONAL
Phase N/A
Enrollment 80
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-02-16
Completion 2034-01-31
Interventions
ACL reconstruction with Shark Screw ACL®ACL reconstruction with biocomposite screw (Mecta)

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Brief Summary

The goal of this clinical trial is to compare the outcome of 2 different screws for Anterior cruciate ligament reconstruction. The main question is if the human allogeneic cortical bone screw reduces tunnel widening in comparison to conventional treatment with a biocomposite screw. Additional the re-rupture rate will be evaluated and knee scores will be recorded before surgery and after surgery. Participants will have MRI before and after surgery, 3, 6, 12, and 24 months after surgery and Computertomography after surgery, 3, 6 and 24 months after surgery. Questionnaires (Knee-scores) will be recorded before surgery, 6, 12, 24 months after surgery. the investigators hope that with the human cortical bone screw the tunnel widening is reduced and the re-rupture rate is low

Eligibility Criteria

Inclusion Criteria: * MRI-verified rupture of the anterior cruciate ligament * Indication for replacement surgery * Surgery within 6 months of injury * Uninjured contralateral knee Exclusion Criteria: * Previous rupture of the anterior cruciate ligament on the side to be operated on (rerupture) * Primary bone disease * inflammatory disease * Unstable meniscus * complete rupture of a collateral ligament * early rerupture during the examination period (early rerupture)

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