Comparing different grafts for knee ligament surgery
Graft Selection in Anatomic Anterior Cruciate Ligament Reconstruction: Patella, Hamstrings or Quadriceps Tendon Autograft
This study is testing whether using a quadriceps tendon for knee ligament surgery works as well as the more common hamstring and patellar tendons in helping young, active people recover from an ACL injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 439 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Orthopedisch Centrum Oost Nederland Academic / other |
| Locations | 2 sites (Groningen and 1 other locations) |
| Trial ID | NCT03073083 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of three different types of autografts—hamstring tendon, patellar tendon, and quadriceps tendon—in anatomic anterior cruciate ligament (ACL) reconstruction. The study aims to determine if the quadriceps tendon autograft is as effective as the more commonly used hamstring and patellar tendon autografts in preventing surgical failure, defined by knee instability or graft discontinuity, over a two-year postoperative period. Participants will be young, active individuals with a primary ACL rupture, and they will follow a standardized rehabilitation protocol. The trial is conducted across multiple centers to ensure a diverse patient population and robust data collection.
Who should consider this trial
Good fit: Ideal candidates for this study are young, active individuals involved in sports with a primary ACL rupture who are willing to adhere to a rehabilitation protocol.
Not a fit: Patients with a history of knee surgery on the same side or significant accompanying knee injuries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify the most effective graft option for ACL reconstruction, potentially improving recovery outcomes for patients.
How similar studies have performed: Previous studies have explored various graft options for ACL reconstruction, but this trial's focus on the quadriceps tendon in the context of anatomic reconstruction is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients active in sports, Tegner =/\>5 * Primary ACL rupture, evident from anamnesis (acute trauma, snapping sensation, swelling within several hours, feeling of instability), physical examination (positive Lachman test, anterior drawertest and/or pivot shift test), radiograph and MRl * Willing to comply to the suggested (nationwide standard) rehabilitation protocol, supen/ised by a NFVS registerd sport-physical therapist * \<6 months between initial trauma and surgery Exclusion Criteria: * History of knee surgery on the same side * History of tendon removal on the same side * Accompanying ligament injury ofthe knee, evident from anamnesis, physical examination, radiograph and MRl, defined as an ACL rupture in combination with a posterior cruciate ligament or collateral ligament injury, * Peroperative discovery of cartilage damage; larger than 2cm2 and more than 50% depth * Peroperative discovery of meniscus injury witch requires a meniscectomy of more than 20% or meniscus sutures * Osteoarthritis of Kellgren and Lawrence grade 2 or more, as evident from the radiograph * Severe malalignment of the leg * Tendency to form excessive scar tissue, such as arthrofibrosis * Muscular, neurological or vascular anomalies that influence healingtime or rehabilitation * Infection * Known hypersensitivity to any of the used materials * Long term relevant medication use such as prednisolone or cytostatics * Pregnancy at the time of inclusion or surgery * Known osteoporosis
Where this trial is running
Groningen and 1 other locations
- Martini Hospital Groningen — Groningen, Netherlands (Not_yet_recruiting)
- Ocon — Hengelo, Netherlands (Recruiting)
Study contacts
- Principal investigator: R.A.G Hoogeslag, MD — Ocon
- Study coordinator: R.A.G Hoogeslag, MD
- Email: wetenschap@ocon.nl
- Phone: 0031887085375
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.