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RECRUITING
NCT06357091
NA

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

Sponsor: Alexander Rofner-Moretti

View on ClinicalTrials.gov

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

Interventions

PROCEDURE

ACL reconstruction with Shark Screw ACL®

ACL reconstruction with the Shark Screw ACL®, Investigation of tunnel widening

PROCEDURE

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