Clinical trial Recruiting at 1 site Interventional Ages 18 to 40

Optimizing graft selection for ACL reconstruction

Official title: Optimizing GRAft SElection for ACL Reconstruction (GRASE-ACL Trial) - a Three-armed Randomized Controlled Trial

Run by Hvidovre University Hospital · NCT05342441 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years to 40 Years
SexAll
Enrollment150 (estimated)
SponsorHvidovre University Hospital
Academic / other
Locations1 site (Hvidovre)
StatusRecruiting
StartedMay 9, 2022
Main results expectedMay 2026
Study endsMay 31, 2028
Registry record updatedAugust 28, 2025
Trial IDNCT05342441 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

Patients with prior knee surgeries, significant osteoarthritis, or other medical conditions that prevent full participation may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: Other studies have explored graft selection in ACL reconstruction, but this trial's comprehensive approach is relatively novel.

Who can join: the full rules

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 it's running

  • Copenhagen University Hospital - Amger/Hvidovre
    Hvidovre, Denmark
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.