Evaluation of Biocleanse Allografts For ACL Reconstruction

Anterior Cruciate Ligament Tear Clinical Trial

Official title: Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation

Status Completed

Clinical Trial Summary

The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

Clinical Trial Description

The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

You are being asked to volunteer in a research study. The purpose of this study is to compare the different ways of cleaning allograft tendons used to replace the main ligament in the knee. The anterior cruciate ligament (ACL) is the main ligament in the knee that your doctor will replace in your surgery. The allograft tendons come from other people who have donated a tendon from the front of the knee after they died.

The three ways of cleaning the tendons that will be used in this study are BioCleanse, irradiation, and aseptic. Aseptic uses clean conditions when preparing the tissue for surgery, sometimes with a chemical bath. BioCleanse is a way of cleaning the tendon physically and chemically, while irradiation uses gamma rays. The goal is to clean the tendons to make them safer for the patients without weakening the tendon when put in the knee. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Tear

• NCT number: NCT00187876
• Study type: Interventional
• Source: University of Florida
• Status: Completed
• Phase: Phase 4
• Start date: February 2004
• Completion date: December 2012