Evaluation of Biocleanse Allografts For ACL Reconstruction

University of Florida

Status and phase: Completed; Phase 4

Conditions: Anterior Cruciate Ligament Tear

Treatments: Procedure: ACL reconstruction control; Procedure: ACL Biocleanse, surgical

Study type: Interventional

Funder types: Other

Identifiers

NCT00187876

566-2003

Details and patient eligibility

About

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

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ACL reconstruction

Exclusion criteria

• none

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

ACL reconstruction control

Active Comparator group

Description:

The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.

Treatment:

Procedure: ACL reconstruction control

ACL Biocleanse, surgical

Experimental group

Description:

The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

Treatment:

Procedure: ACL Biocleanse, surgical