Actively Recruiting
Tunnel Widening in Augmented ACL Integration Via PrP Enriched Collected Autologous Bone vs Standard ACL Technique
Led by Schulthess Klinik · Updated on 2024-01-29
107
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 18-50 years
- Primary ACL rupture
- Time from injury to surgery between 4 weeks and 6 months
- Single, isolated ACL rupture
- ACL surgery performed by one of the participating senior surgeons
- Signed informed consent provided
You will not qualify if you...
- Other ligament instability or rupture in the same knee
- Need for meniscus suture (partial resection allowed if hoop and roots intact)
- Need for cartilage invasive treatment (debridement allowed)
- Osteoarthritis in the injured knee joint
- Leg axis deviation over 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
Trial Site Locations
Total: 1 location
1
Schulthess Klinik
Zurich, Switzerland, 8008
Actively Recruiting
Research Team
V
Vincent A Stadelmann, PhD
CONTACT
A
Anika Stephan, MA
CONTACT
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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