Status:
RECRUITING
Optimizing Graft Selection for ACL Reconstruction
Lead Sponsor:
Hvidovre University Hospital
Collaborating Sponsors:
University College Copenhagen
National Research Centre for the Working Environment, Denmark
Conditions:
ACL - Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
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 individ...
Detailed Description
Purpose: The aim of this randomized controlled trial is to investigate the effect of graft choice in anterior cruciate ligament (ACL) reconstruction surgery, primarily from a patient-centered as well...
Eligibility Criteria
Inclusion
- List of Inclusion criteria
- clinically confirmed first-time ACL rupture
- Current injury sustai´ned within 2 years
- high activity level prior to ACL rupture (Tegner score ≥ 3) and personal goal of returning to physical activity.
- List of preoperative exclusion criteria
- Inadequate Danish language skills to answer questionnaires.
- 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 ≥ 2)
- Prior open surgery to either knee
- Prior severe fracture involving knee joint surfaces
- Prior severe injury to thigh muscles in either leg (e.g. tear or compartment)
- Prior severe injury to the patella tendon of either knee (e.g. subluxation)
- Medical condition preventing full participation (e.g. active cancer, - rheumatoid arthritis)
- Psychiatric condition preventing full participation
- Pregnancy
- Obesity (BMI \> 30)
- List of Perioperative exclusion criteria (Arthroscopy)
- Medial meniscus lesion \> 50%
- Lateral meniscus lesion \> 50%
- Treated Meniscal root lesion or radial meniscal tear that require restrictive regimen
- Cartilage lesion \>2cm2, Articular cartilage injury classification (ICRS) grade 3
- Concurrent ligament injury (except medial collateral ligament (MCL) lesion grade 1-2)
Exclusion
Key Trial Info
Start Date :
May 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05342441
Start Date
May 9 2022
End Date
May 31 2028
Last Update
August 28 2025
Active Locations (1)
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1
Copenhagen University Hospital - Amger/Hvidovre
Hvidovre, Denmark, 2650