MedTrace Logo

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

NCT06357091 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-01-21

No results posted yet for this study

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

Conditions

  • Anterior Cruciate Ligament Rupture
  • Anterior Cruciate Ligament Reconstruction
  • Anterior Cruciate Ligament Injury

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

Sponsors & Collaborators

  • Alexander Rofner-Moretti

    lead OTHER

Principal Investigators

  • Alexander Rofner-Moretti, MD · Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-16
Primary Completion
2034-01-31
Completion
2034-01-31

Countries

  • Austria

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357091 on ClinicalTrials.gov