Comparing two methods for fixing knee ligament grafts
A Prospective Randomized Controlled Trial Comparing the Endobutton CL BTB Fixation System With Metal Interference Screws in the Femoral Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction.
NA · St. Olavs Hospital · NCT02918734
This study is testing which method of fixing knee ligament grafts works better for people getting ACL surgery, comparing a special button system to metal screws.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | St. Olavs Hospital (other) |
| Locations | 2 sites (Trondheim and 1 other locations) |
| Trial ID | NCT02918734 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of two different fixation methods for bone-patellar tendon-bone autografts used in anterior cruciate ligament (ACL) reconstruction. Patients will be randomly assigned to receive either the Endobutton CL BTB Fixation System or metal interference screws for femoral fixation. The study will assess various outcomes, including patient-reported results, knee laxity, range of motion, and muscle strength, with a primary focus on knee-related quality of life two years post-surgery. This is the first randomized controlled trial to directly compare these two fixation techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals undergoing primary ACL reconstruction with a bone-patellar tendon-bone autograft.
Not a fit: Patients with previous major knee surgeries or those requiring different graft types due to medical indications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing ACL reconstruction.
How similar studies have performed: While the Endobutton fixation method has shown promising results in other contexts, this specific comparison has not been previously tested in randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary reconstruction of ACL ruptures * Surgery at least 6 weeks after injury * The patient must accept and sign the informed consent form before surgery Exclusion Criteria: * Medical indication for using another graft than BPTB autograft (such as history of anterior knee pain or occupations etc. requiring frequent kneeling) * Previous major surgical procedures in the same knee * Major additional injuries in the knee (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions and major cartilage lesions undergoing cartilage repair) * Contralateral ACL injury (treated or untreated) * Present or former serious illness that makes follow-up or rehabilitation difficult (e.g. alcohol or drug abuse, psychiatric disease)
Where this trial is running
Trondheim and 1 other locations
- Department of Orthopedic Surgery, St Olavs Hospital — Trondheim, Norway (RECRUITING)
- Rosenborgklinikken — Trondheim, Norway (RECRUITING)
Study contacts
- Principal investigator: Jon Olav Drogset, md phd — St. Olavs Hospital
- Study coordinator: Trond Olav Lundemo, md
- Email: TrondOlav.Lundemo@helse-nordtrondelag.no
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.
Conditions: Knee Injuries, Anterior Cruciate Ligament, Bone-Patellar Tendon-Bone Grafting