Actively Recruiting
A Prospective Randomized Controlled Trial Comparing the Endobutton CL BTB Fixation System With Metal Interference Screws in Femoral Fixation of Patellar Tendon Grafts for ACL Reconstruction
Led by St. Olavs Hospital · Updated on 2025-07-10
220
Participants Needed
2
Research Sites
326 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
R
Rosenborgklinikken
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two methods of femoral fixation for bone-patellar tendon-bone (BPTB) autografts used in primary anterior cruciate ligament (ACL) reconstruction. The study aims to evaluate the outcomes of using the Endobutton CL BTB Fixation System versus traditional metal interference screws, as no randomized trials have yet compared these devices. The focus is on patient-reported outcomes, knee function, and bone healing in patients undergoing ACL reconstruction. Participants will be randomly assigned to receive femoral fixation with either the Endobutton CL BTB device or a metal interference screw, while the tibial fixation will use a metal interference screw in both groups. Follow-up visits are scheduled at 6 weeks, 6 months, 2 years, and 10 years after surgery. A CT scan will assess bone block integration at 6 months, while X-rays will check for osteoarthritis development at 2 and 10 years. Rehabilitation details will also be recorded. Throughout the study, participants will undergo assessments including patient-reported knee quality of life measured by the KOOS questionnaire at multiple time points, muscle strength, range of motion, and knee stability tests. The primary outcome is knee-related quality of life at 2 years. Complications, revisions, and radiographic changes will be monitored over the long term. Patients undergoing revision surgery will continue follow-up but will be excluded from further comparisons.
CONDITIONS
Brief Title
Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primary reconstruction of ACL ruptures
- Surgery planned at least 6 weeks after injury
- Patient accepts and signs informed consent before surgery
- Age between 18 and 55 years
You will not qualify if you...
- Medical need for a different graft than BPTB autograft
- History of anterior knee pain or jobs requiring frequent kneeling
- Previous major surgery on the same knee
- Major additional knee injuries (e.g., other ligament injuries, meniscus lesions requiring repair, major cartilage damage needing repair)
- Injury to the opposite knee (treated or untreated ACL injury)
- Serious illness making follow-up or rehabilitation difficult (e.g., substance abuse, psychiatric disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo ACL reconstruction surgery using either the Endobutton CL BTB Fixation System or metal interference screws for femoral fixation of the patellar tendon graft, followed by immediate post-operative care.
1 visit (in-person)
Duration - Up to 10 years
Participants attend follow-up visits to assess recovery, including knee related quality of life, muscular strength, range of motion, and knee stability tests.
Visits at 6 weeks, 6 months, 2 years, and 10 years (in-person)
Duration - At 6 months, 2 years, and 10 years after surgery
Participants undergo imaging assessments to evaluate bone block integration and osteoarthritis development.
CT scan at 6 months and radiographs at 2 and 10 years (in-person)
Trial Site Locations
Total: 2 locations
1
Department of Orthopedic Surgery, St Olavs Hospital
Trondheim, Norway
Actively Recruiting
2
Rosenborgklinikken
Trondheim, Norway
Actively Recruiting
Research Team
T
Trond Olav Lundemo, md
T
Tone Gifstad, md phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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