ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlexander Rofner-Moretti

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

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Alexander Rofner-Moretti

Lead sponsor

Bezirkskrankenhaus Schwaz

Sponsor institution