NCT00187876

Evaluation of Biocleanse Allografts For ACL Reconstruction

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Anterior Cruciate Ligament Tear

Interventions

Type	Name	Description
PROCEDURE	ACL reconstruction control	The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
PROCEDURE	ACL Biocleanse, surgical	The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

Timeline

• Start date: 2004-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2005-09-16
• Last updated: 2014-03-04
• Results posted: 2014-03-04

Locations

1 site across 1 country: United States