Comparing two surgical techniques for ACL reconstruction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to compare the outcomes of two surgical techniques for anterior cruciate ligament (ACL) reconstruction after a primary ACL tear. Participants will be randomly assigned to either an experimental group receiving a bone and platelet-rich plasma (PrP) composite material or a control group undergoing standard ACL reconstruction. The study will assess tibial tunnel widening and graft incorporation using CT and MRI scans, along with functional knee testing and patient-reported outcomes over a 24-month follow-up period. The goal is to determine if the composite material can reduce tunnel widening and improve graft integration.

Why it matters

Who can join: the full rules

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.

Where it's running

• Schulthess Klinik
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Gian Salzmann, Prof. — Schulthess Klinik
• Study coordinator: Vincent A Stadelmann, PhD
• Email: vincent.stadelmann@kws.ch
• Phone: +41 44 385

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Vibration therapy for knee pain after ACL surgery

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  Recruiting Phase 2 Chinese University of Hong Kong · Hong Kong · NCT05174611

• Comparing two types of grafts for knee ligament surgery

  This study is testing which type of graft works better for knee ligament surgery in athletes who have injured their ACL.

  Recruiting Karolinska Institutet · Stockholm, Stockholm County · NCT04295148

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.