RecruitingNot ApplicableNCT02918734

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

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.


Sponsor

St. Olavs Hospital

Enrollment

220 participants

Start Date

Oct 1, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Endobutton CL BTB and a medical device called Metal interference screw for people with knee injuries. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndobutton CL BTB

ACL reconstruction with Endobutton CL BTB

DEVICEMetal interference screw

ACL reconstruction with metal interference screw


Locations(2)

Department of Orthopedic Surgery, St Olavs Hospital

Trondheim, Norway

Rosenborgklinikken

Trondheim, Norway

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NCT02918734


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