Optimizing graft selection for ACL reconstruction
Optimizing GRAft SElection for ACL Reconstruction (GRASE-ACL Trial) - a Three-armed Randomized Controlled Trial
This study is testing which type of graft—quadriceps tendon, hamstring tendons, or patellar tendon—works best for helping young adults recover from their first ACL injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 1 site (Hvidovre) |
| Trial ID | NCT05342441 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the differences between three common methods for anterior cruciate ligament (ACL) reconstruction: using grafts from the quadriceps tendon, hamstring tendons, or patellar tendon. The study aims to provide a patient-centered and biomechanical perspective on how graft choice affects knee function, muscle strength, and overall surgical outcomes. By employing a randomized controlled design, 150 patients aged 18-40 with first-time ACL ruptures will be followed to assess the effectiveness of each graft type. The goal is to develop evidence-based, individualized treatment options for ACL injuries.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-40 with a clinically confirmed first-time ACL rupture and a high activity level prior to injury.
Not a fit: Patients with prior knee surgeries, significant osteoarthritis, or other medical conditions that prevent full participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and personalized treatment strategies for patients undergoing ACL reconstruction.
How similar studies have performed: Other studies have explored graft selection in ACL reconstruction, but this trial's comprehensive approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Hvidovre
- Copenhagen University Hospital - Amger/Hvidovre — Hvidovre, Denmark (Recruiting)
Study contacts
- Study coordinator: Merete B Speedtsberg, MSc
- Email: MSPE0006@regionh.dk
- Phone: +45 38622381
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.