Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06357091

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

Led by Alexander Rofner-Moretti · Updated on 2026-01-21

80

Participants Needed

1

Research Sites

415 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • MRI-verified rupture of the anterior cruciate ligament
  • Indication for replacement surgery
  • Surgery within 6 months of injury
  • Uninjured contralateral knee
Not Eligible

You will not qualify if you...

  • 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)

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Bezirkskrankenhaus Schwaz Betriebsgesellschaft m.b.H

Schwaz, Tyrol, Austria, 6130

Actively Recruiting

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Research Team

A

Alexander Rofner-Moretti, MD

CONTACT

M

Markus Reichkendler, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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