Evaluation of Biocleanse Allografts For ACL Reconstruction

Phase 4

Completed

• Conditions: Anterior Cruciate Ligament Tear
• Interventions: Procedure: ACL reconstruction control; Procedure: ACL Biocleanse, surgical

• Registration Number: NCT00187876
• Lead Sponsor: University of Florida

Brief 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.

Study Timeline

• Study Start: 2004-02
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Results First Submitted: 2013-12-04
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-30
• Last Update Submitted: 2014-01-30
• Results First Posted: 2014-03-04
• Last Update Posted: 2014-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• ACL reconstruction

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
International Knee Documentation Committee (IKDC) Form	24 month period	The IKDC Subjective Evaluation Form is scored by summing the scores for the individual items and then transforming the score to a scale that ranges from 0-100. A score of 100 is interpreted to mean no limitation with activities of daily living and the absence of symptoms.

Trial Locations

Locations (1)

UF Orthopedics and Sports Medicine Institute; 🇺🇸 Gainesville, Florida, United States