Actively Recruiting
Optimizing Graft Selection for ACL Reconstruction (GRASE-ACL Trial) A Three-armed Randomized Controlled Trial
Led by Hvidovre University Hospital · Updated on 2025-08-28
150
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
Sponsors
H
Hvidovre University Hospital
Lead Sponsor
U
University College Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the differences between the three most common surgical methods for reconstructing a torn anterior cruciate ligament (ACL) to identify the best approach for each individual patient. This randomized controlled trial focuses on young adults aged 18 to 40 who have experienced a first-time ACL rupture. The study aims to examine patient-reported knee function, biomechanical muscle strength, clinical knee stability, and muscle structure after surgery using a comprehensive scientific approach. Participants are randomly assigned to receive ACL reconstruction using one of three types of autografts: the quadriceps tendon (QT), the semitendinosus and gracilis tendons (ST/Gr), or the patella tendon with bone blocks (BPTB). Each procedure involves harvesting the graft through small incisions and anatomically placing tunnels in the knee to secure the graft. Patients then follow Danish rehabilitation guidelines after surgery. The study includes follow-ups at 1, 6, 12, and 24 months after surgery to monitor progress. Throughout the study, participants complete standardized questionnaires to report knee function and quality of life. Researchers also perform detailed biomechanical analyses including 3-D motion capture and muscle power tests, clinical knee examinations, and MRI scans to assess muscle morphology. The main outcomes measured at 12 months are the International Knee Documentation Committee (IKDC) score and the rate of force development limb symmetry index (RFD-LSI). Safety and clinical outcomes such as knee stability and revision surgeries are also tracked during the follow-up period.
CONDITIONS
Brief Title
Optimizing Graft Selection for ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically confirmed first-time ACL rupture
- Injury sustained within the past 2 years
- High activity level prior to ACL rupture (Tegner score 63 3)
- Personal goal of returning to physical activity
- Age between 18 and 40 years
- Ability to understand Danish to complete questionnaires
You will not qualify if you...
- Prior ligament surgery in the injured knee
- Prior ligament surgery in the non-injured knee
- Instability of the non-injured knee
- Known osteoarthritis (Kelgren Lawrence score 63 2)
- Prior open surgery to either knee
- Prior severe fracture involving knee joint surfaces
- Prior severe injury to thigh muscles in either leg
- Prior severe injury to the patella tendon of either knee
- Medical conditions preventing full participation (e.g., active cancer, rheumatoid arthritis)
- Psychiatric condition preventing full participation
- Pregnancy
- Obesity (BMI > 30)
- Medial meniscus lesion greater than 50%
- Lateral meniscus lesion greater than 50%
- Treated meniscal root lesion or radial meniscal tear requiring restrictive regimen
- Cartilage lesion larger than 2 cm2 (ICRS grade 3)
- Concurrent ligament injury except MCL lesion grade 1-2
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 - Single surgical event with subsequent recovery
Participants undergo ACL reconstruction surgery using one of three graft types: quadriceps tendon (QT), semitendinosus/gracilis tendons (ST/Gr), or patella tendon with bone plugs (BPTB). Surgery includes arthroscopic knee assessment and graft implantation, followed by rehabilitation according to Danish guidelines.
1 surgical visit (in-person) and rehabilitation visits as part of routine care
Duration - 24 months
Participants are monitored to assess knee function, strength, stability, donor site discomfort, and other clinical outcomes at multiple timepoints after surgery.
Visits at 1, 6, 12, and 24 months post-surgery
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital - Amger/Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
M
Merete B Speedtsberg, MSc
C
Cecilie K Olsen, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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