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Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique

RecruitingNAAges 18 Years - 50 YearsAllSchulthess Klinik
NCT05953051 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this clinical study is to compare the outcomes of two surgical techniques for reconstruction of the anterior cruciate ligament (ACL) after a single, primary ACL rupture. The main question to be answered is: \- Does less widening of the tibial tunnel occur when a bone/Platelet rich plasma (PrP) composite material is placed directly into the tibial tunnel after fixation of the implant (experimental group) compared to the same surgery without the use of the composite material (control group)? Participants will be randomized into one of the two groups and they will not know which group they belong to. After 12 months they will undergo CT, MRI, medical examination and functional knee testing. They will have a further medical examination and functional knee testing at 24 months. Patient Reported Outcomes will be collected before surgery, 6, 12 and 24 months after surgery.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-50 years * Primary ACL rupture * Time from injury to surgery: 4 weeks to 6 months * Single ACL rupture (isolated rupture) * ACL surgery with one of the participating senior surgeons * Informed Consent as documented by signature Exclusion Criteria: * Concomitant ligamentous instability/rupture * Requirement for Meniscus suture (partial resection accepted, hoop and roots remain intact) * Requirement for cartilage invasive treatment (debridement accepted) * Osteoarthritis at index knee joint * Leg axis deviation over 3° valgus or 4° varus * Claustrophobia (contra-indication for the MRI) * Women who are pregnant or breast feeding or intention to become pregnant during the study * Known or suspected non-compliance, drug or alcohol abuse * Inability of the patient to follow the study procedures, e.g. language problems, psychological disorders, dementia, etc.
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What it tests

  • ACL reconstruction with bone/PrP-composite
  • ACL reconstruction (Standard)
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Where

1 site
Schulthess Klinik
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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