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Evaluation of Biocleanse Allografts For ACL Reconstruction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00187876
First Posted: September 16, 2005
Last Update Posted: March 4, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Florida
September 12, 2005
September 16, 2005
December 4, 2013
March 4, 2014
March 4, 2014
February 2004
December 2012   (Final data collection date for primary outcome measure)
International Knee Documentation Committee (IKDC) Form [ Time Frame: 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.
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Complete list of historical versions of study NCT00187876 on ClinicalTrials.gov Archive Site
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Evaluation of Biocleanse Allografts For ACL Reconstruction
Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
The purpose of this study is to determine the efficacy of patellar tendon allografts that have undergone the BioCleanse™ process.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Anterior Cruciate Ligament Tear
  • 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
  • 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
  • Active Comparator: ACL reconstruction control
    The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
    Intervention: Procedure: ACL reconstruction control
  • 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.
    Intervention: Procedure: ACL Biocleanse, surgical
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
December 2012
December 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ACL reconstruction

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00187876
566-2003
Yes
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University of Florida
University of Florida
Not Provided
Principal Investigator: Peter A. Indelicato, M.D. University of Florida
University of Florida
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP