Actively Recruiting
Optimizing Graft Selection for ACL Reconstruction
Led by Hvidovre University Hospital · Updated on 2025-08-28
150
Participants Needed
1
Research Sites
316 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
Purpose: To investigate the differences between the three most common methods for reconstruction of the anterior cruciate ligament (ACL), to support the development of the best method for the individual patient. Main research area: ¨ Sports Orthopedic Surgical research. State of the art: Every year in Denmark 2500 patients receive surgical reconstruction surgery to replace a ruptured ACL. Many patients experience a decline in knee function and 4-12% suffer a new ACL rupture within 5 years. According to data from the Danish ACL register, three methods of reconstruction are most prevalent, but with large variation between hospitals. This indicates lack of consensus on optimal surgical procedure. Design: Assessor-blinded randomized controlled study. 150 patients aged 18-40 with ruptured ACL are allocated to reconstruction with tendon(s) harvested from either the semitendinosus and gracilis, or the patella tendon, or the quadriceps tendon. Patient follow-up will be conducted preoperatively and 1, 6, 12, 24 months postoperatively. Primary technologies and outcomes: * Patient-reported knee-joint function, quality of life and donor-site morbidity is obtained with standardized questionnaires. Primary outcome is subjective knee function with the International Knee Documentation Committee evaluation form (IKDC) * Instrumented analysis of knee-joint coordination and neuromuscular control including 3-D motion capture and electromyography (EMG) during single leg jumps, landings and change-of-direction. Measurement of maximal explosive muscle power in knee extension and flexion. Primary outcome is relative difference between injured and healthy leg in rate of force development (RFD-LSI). * Standard clinical knee examination of range of motion and instrumented examination of knee-joint stability. * Magnetic Resonance Imaging (MRI) of the thigh muscles for examination of muscle morphology. The trial is designed for publication in three primary publications 1. \- Patient reported effect of graft choice in ACL reconstruction 2. \- Biomechanical effect of graft choice in ACL reconstruction 3. \- Clinical effect of graft choice in ACL reconstruction Additional secondary publications are in the pipeline. Reference to primary protocol and results will always be emphasized in secondary publication to ensure methodological transparency.
CONDITIONS
Official Title
Optimizing Graft Selection for ACL Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically confirmed first-time ACL rupture
- Injury occurred within the last 2 years
- High activity level before injury (Tegner score 3 or higher)
- Personal goal to return to physical activity
- Age between 18 and 40 years
You will not qualify if you...
- Inadequate Danish language skills to answer questionnaires
- Previous ligament surgery in the injured knee
- Previous ligament surgery in the non-injured knee
- Instability in the non-injured knee
- Known osteoarthritis with Kelgren Lawrence score 2 or higher
- Previous open surgery on either knee
- Severe fracture involving knee joint surfaces
- Severe injury to thigh muscles in either leg
- Severe injury to the patella tendon of either knee
- Medical conditions preventing full participation (e.g., active cancer, rheumatoid arthritis)
- Psychiatric conditions preventing full participation
- Pregnancy
- Obesity with BMI over 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 2cm2 with ICRS grade 3
- Concurrent ligament injury except medial collateral ligament lesion grade 1-2
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Copenhagen University Hospital - Amger/Hvidovre
Hvidovre, Denmark, 2650
Actively Recruiting
Research Team
M
Merete B Speedtsberg, MSc
CONTACT
C
Cecilie K Olsen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here