Evaluation of Biocleanse Allografts For ACL Reconstruction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT00187876
First received: September 12, 2005
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Anterior Cruciate Ligament Tear
Procedure: ACL reconstruction control
Procedure: ACL Biocleanse, surgical
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • International Knee Documentation Committee (IKDC) Form [ Time Frame: 24 month period ] [ Designated as safety issue: No ]
    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.


Enrollment: 67
Study Start Date: February 2004
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
Procedure: ACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Other Name: Standard ACL allograft
Experimental: ACL Biocleanse, surgical
The intervention consists of the surgical 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.
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ACL reconstruction

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00187876

Locations
United States, Florida
UF Orthopedics and Sports Medicine Institute
Gainesville, Florida, United States, 32611
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Peter A. Indelicato, M.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00187876     History of Changes
Other Study ID Numbers: 566-2003
Study First Received: September 12, 2005
Results First Received: December 4, 2013
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 17, 2014