Actively Recruiting

Phase Not Applicable
Age: 18Years - 40Years
All Genders
NCT05342441

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

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Copenhagen University Hospital - Amger/Hvidovre

Hvidovre, Denmark, 2650

Actively Recruiting

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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

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