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ACL Reconstruction With Shark Screw® or Biocomposite-interference Screws

ConditionsAnterior Cruciate Ligament RuptureAnterior Cruciate Ligament ReconstructionAnterior Cruciate Ligament Injury
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • ACL reconstruction with Shark Screw ACL®

    Procedure/Surgery

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

  • ACL reconstruction with biocomposite screw (Mecta)

    Procedure/Surgery

    ACL reconstruction with biocomposite screw (Mecta), Investigation of tunnel widening

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ACL reconstruction with human allogeneic cortical bone screw (Shark Screw®)Experimental treatment 1 intervention
Group B: ACL reconstruction with Mecta Composite interference screwActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

bone tunnel widening will be measured by CT and/or MRI and measured in mm

bone tunnel widening will be evaluated and measured by CT and/or MRI and measured in mm

Time frame
immadiately after surgery, 3, 6, 12 and 24 months after surgery.

Secondary outcomes

1

International Knee Documentation Committee (IKDC) Scores

IKDC will be evaluated by questionnaires, it can be between 0 and 100 the higher the better is the outcome

Time frame
before surgery and 6, 12 and 24 months after surgery
2

Knee Injury and Osteoarthritis Outcome Score (KOOS) Scores

KOOS Score will be evaluated by questionnaires, it can be between 0 and 100 the higher the better is the outcome

Time frame
before surgery and 6, 12 and 24 months after surgery
3

Lysholm Knee Score

Lysholm Knee Score will be evaluated by questionnaires, one of the most frequently used assessment tools for the results of Anterior cruciate ligament reconstruction even though it only measures activities of daily living, it can be between 0 and 100 the higher the better is the outcome.

Time frame
before surgery and 6, 12 and 24 months after surgery
4

Tegner Activity Score

Tegner Activity Score will be evaluated by questionnaires

Time frame
before surgery and 6, 12 and 24 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexander Rofner-Moretti

Lead sponsor

Bezirkskrankenhaus Schwaz

Sponsor institution

Source ClinicalTrials.gov
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