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Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws
Sponsor: St. Olavs Hospital
Summary
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.
Official title: 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.
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2016-10
Completion Date
2033-03
Last Updated
2025-07-10
Healthy Volunteers
No
Conditions
Interventions
Endobutton CL BTB
ACL reconstruction with Endobutton CL BTB
Metal interference screw
ACL reconstruction with metal interference screw
Locations (2)
Department of Orthopedic Surgery, St Olavs Hospital
Trondheim, Norway
Rosenborgklinikken
Trondheim, Norway