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RECRUITING
NCT02918734
NA

Fixation of Patellar Tendon Grafts in Anterior Cruciate Ligament Reconstruction. Endobutton vs Metal Interference Screws

Sponsor: St. Olavs Hospital

View on ClinicalTrials.gov

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

DEVICE

Endobutton CL BTB

ACL reconstruction with Endobutton CL BTB

DEVICE

Metal interference screw

ACL reconstruction with metal interference screw

Locations (2)

Department of Orthopedic Surgery, St Olavs Hospital

Trondheim, Norway

Rosenborgklinikken

Trondheim, Norway