Comparing two surgical techniques for ACL reconstruction
A Single-center, Patient-blinded, Randomized, 2-year, Parallel-group, Superiority Study to Compare the Efficacy of Augmented ACL Integration Via Platelet-rich-plasma Enriched Collected Autologous Bone Versus Standard ACL Technique
This study is testing if using a special material made of bone and platelet-rich plasma during ACL surgery can help people recover better and have fewer problems with their knees compared to standard surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 107 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Schulthess Klinik Academic / other |
| Locations | 1 site (Zurich) |
| Trial ID | NCT05953051 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-50 with a primary ACL rupture occurring within 4 weeks to 6 months prior to surgery.
Not a fit: Patients with concomitant ligamentous injuries, significant osteoarthritis, or those requiring invasive cartilage treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved outcomes and reduced complications for patients undergoing ACL reconstruction.
How similar studies have performed: While similar approaches have been explored, this specific combination of techniques is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zurich
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.