About this trial
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
Qualifiers
MRI-verified rupture of the anterior cruciate ligament
Indication for replacement surgery
Surgery within 6 months of injury
Uninjured contralateral knee
Disqualifiers
Previous rupture of the anterior cruciate ligament on the side to be operated on (rerupture)
Primary bone disease
inflammatory disease
Unstable meniscus
Trial design
Treatments tested in this trial
- ACL reconstruction with Shark Screw ACL®
- ACL reconstruction with biocomposite screw (Mecta)
Treatment groups
Sponsors and collaborators
Alexander Rofner-Moretti
Lead sponsor
Bezirkskrankenhaus Schwaz
Sponsor institution