Actively Recruiting
A Patient-blinded, Randomized Study Comparing Augmented ACL Reconstruction Using Platelet-rich Plasma Enriched Autologous Bone Versus Standard ACL Technique with 2-year Follow-up
Led by Schulthess Klinik · Updated on 2024-01-29
107
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying two different surgical methods for reconstructing the anterior cruciate ligament (ACL) after a first-time ACL tear. The main goal is to see if using a composite made from the patient's own bone fragments and platelet-rich plasma (PrP) in the tibial tunnel can reduce tunnel widening compared to the standard ACL surgery without this composite. This study is a randomized, controlled trial with two groups and follows patients for 24 months to evaluate this and other outcomes. Participants will be randomly assigned to one of two groups. The experimental group will have a bone/PrP composite inserted into the tibial tunnel during ACL surgery, while the control group will receive the standard ACL reconstruction without this composite. The surgery involves collecting bone debris, mixing it with PrP, and applying it to the tunnel interface in the experimental group. Both groups follow the same overall surgical procedure except for this addition. During the study, participants will have assessments including CT and MRI scans, medical exams, and knee function tests at 12 months after surgery, with additional exams and tests at 24 months. Patient-reported outcomes will be gathered before surgery and at 6, 12, and 24 months after. Researchers will measure changes in tunnel size, graft incorporation and maturation, knee function, and monitor for any complications or adverse events over the 2-year follow-up period.
CONDITIONS
Brief Title
Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 50 years
- Primary ACL rupture
- Time from injury to surgery between 4 weeks and 6 months
- Single, isolated ACL rupture
- Surgery performed by one of the participating senior surgeons
- Signed informed consent
You will not qualify if you...
- Additional ligament instability or rupture
- Need for meniscus suture (partial meniscus removal allowed if hoop and roots remain intact)
- Requirement for cartilage invasive treatment (debridement allowed)
- Osteoarthritis in the knee joint
- Leg axis deviation greater than 3° valgus or 4° varus
- Claustrophobia preventing MRI
- Women who are pregnant, breastfeeding, or planning pregnancy during the study
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to follow study procedures due to language, psychological, or cognitive issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo ACL reconstruction surgery, either with the bone/PrP-composite inserted into the tibial tunnel or with the standard ACL reconstruction technique without additional material.
1 visit (in-person)
Duration - 24 months
Participants are monitored and assessed for graft and bone integration, tunnel widening, graft maturity, and knee function over a 24-month follow-up period.
Visits at 0, 6, 12, and 24 months post-surgery
Trial Site Locations
Total: 1 location
1
Schulthess Klinik
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
V
Vincent A Stadelmann, PhD
A
Anika Stephan, MA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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