Actively Recruiting
Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws
Led by St. Olavs Hospital · Updated on 2025-07-10
220
Participants Needed
2
Research Sites
856 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
R
Rosenborgklinikken
Collaborating Sponsor
AI-Summary
What this Trial Is About
In this randomized controlled trial the investigators will compare the results after primary anterior cruciate ligament (ACL) reconstruction using two different methods for femoral fixation of a bone-patellar tendon-bone (BPTB) autograft. Interference screws have been the standard method for fixing the femoral side of BPTB grafts; however, several pitfalls have been reported. Cortical fixation with the Endobutton CL BTB Fixation System has become available and the clinical results have been described as promising; however, no randomized controlled trials comparing these two femoral fixation methods have been conducted, and there is no published data that confirms that the bone block heals in the tunnel with the newer method. The aim of our study is to compare the outcome after primary ACL reconstruction with BPTB autografts using the Endobutton CL BTB or metal interference screw for femoral fixation.
CONDITIONS
Official 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 at least 6 weeks after injury
- Patient must accept and sign informed consent before surgery
You will not qualify if you...
- Medical reason to use a graft other than BPTB autograft (e.g., history of anterior knee pain or jobs requiring frequent kneeling)
- Previous major surgery on the same knee
- Major additional knee injuries (posterior cruciate ligament, lateral collateral ligament, medial collateral ligament, sutured meniscus lesions, or major cartilage lesions needing repair)
- Injury to the opposite knee's ACL (treated or untreated)
- Present or past serious illness making follow-up or rehabilitation difficult (e.g., alcohol or drug abuse, psychiatric disease)
AI-Screening
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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
CONTACT
T
Tone Gifstad, md phd
CONTACT
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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