Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
Recruiting now · Not applicable
Conditions studied: Anterior Cruciate Ligament Tear
In brief
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.
Key facts
- Study ID
- NCT05953051
- Run by
- Schulthess Klinik
- People needed
- 107
- Starts
- 2024-01-01
- Expected to finish
- 2027-08-01
- Last updated by the study team
- 2024-01-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Schulthess Klinik — Zurich, Switzerland (enrolling)
Full record on ClinicalTrials.gov
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