NCT05953051 Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
| NCT ID | NCT05953051 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Schulthess Klinik |
| Condition | Anterior Cruciate Ligament Tear |
| Study Type | INTERVENTIONAL |
| Enrollment | 107 participants |
| Start Date | 2024-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 107 participants in total. It began in 2024-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Gian Salzmann, Prof.
PRINCIPAL INVESTIGATOR
Schulthess Klinik
Frequently Asked Questions
Who can join the NCT05953051 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Anterior Cruciate Ligament Tear. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05953051 currently recruiting?
Yes, NCT05953051 is actively recruiting participants. Contact the research team at vincent.stadelmann@kws.ch for enrollment information.
Where is the NCT05953051 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT05953051 clinical trial?
NCT05953051 is sponsored by Schulthess Klinik. The principal investigator is Gian Salzmann, Prof. at Schulthess Klinik. The trial plans to enroll 107 participants.