NCT05342441 Optimizing Graft Selection for ACL Reconstruction

Eligibility & Interventions

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This trial targets 150 participants in total. It began in 2022-05-09 with a primary completion date of 2026-05.

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 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.

Eligibility Criteria

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)

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