ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
Alexander Rofner-Moretti
80 participants
Feb 16, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- MRI-verified rupture of the anterior cruciate ligament
- Indication for replacement surgery
- Surgery within 6 months of injury
- Uninjured contralateral knee
Exclusion Criteria6
- 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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Interventions
ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening
ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening
Locations(1)
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NCT06357091