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ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

RecruitingNAAges 18 Years - anyAllAlexander Rofner-Moretti
NCT06357091 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • ACL reconstruction with Shark Screw ACL®
  • ACL reconstruction with biocomposite screw (Mecta)
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Where

1 site
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
Schwaz, Austria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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