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ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws
Sponsor: Alexander Rofner-Moretti
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
Official title: ACL Reconstruction With Human Allograft Cortical Bone Screw (Shark Screw®) or Biocomposite-interference Screws - a Prospective, Randomized, Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-02-16
Completion Date
2034-01-31
Last Updated
2026-01-21
Healthy Volunteers
No
Conditions
Interventions
ACL reconstruction with Shark Screw ACL®
ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening
ACL reconstruction with biocomposite screw (Mecta)
ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening
Locations (1)
Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H
Schwaz, Tyrol, Austria