ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

Recruiting now · Not applicable

Conditions studied: Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Injury

In brief

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

Key facts

Study ID: NCT06357091
Run by: Alexander Rofner-Moretti
People needed: 80
Starts: 2026-02-16
Expected to finish: 2034-01-31
Last updated by the study team: 2026-01-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

MRI-verified rupture of the anterior cruciate ligament
Indication for replacement surgery
Surgery within 6 months of injury
Uninjured contralateral knee

You may not qualify if…

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)

Where it is running

Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H — Schwaz, Tyrol, Austria (enrolling)

Full record on ClinicalTrials.gov

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