Back to resultsEvaluation of Biocleanse Allografts For ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Tear
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ACL reconstruction control
ACL Biocleanse, surgical
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear
Eligibility Criteria
Inclusion Criteria: ACL reconstruction Exclusion Criteria: none
Sites / Locations
- UF Orthopedics and Sports Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
ACL reconstruction control
ACL Biocleanse, surgical
Arm Description
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Outcomes
Primary Outcome Measures
International Knee Documentation Committee (IKDC) Form
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00187876
First Posted
September 12, 2005
Last Updated
January 30, 2014
Sponsor
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT00187876
Brief Title
Evaluation of Biocleanse Allografts For ACL Reconstruction
Official Title
Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ACL reconstruction control
Arm Type
Active Comparator
Arm Description
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
Arm Title
ACL Biocleanse, surgical
Arm Type
Experimental
Arm Description
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Intervention Type
Procedure
Intervention Name(s)
ACL reconstruction control
Other Intervention Name(s)
Standard ACL allograft
Intervention Description
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Intervention Type
Procedure
Intervention Name(s)
ACL Biocleanse, surgical
Other Intervention Name(s)
BioCleanse™ process
Intervention Description
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Primary Outcome Measure Information:
Title
International Knee Documentation Committee (IKDC) Form
Description
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.
Time Frame
24 month period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ACL reconstruction
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Indelicato, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Orthopedics and Sports Medicine Institute
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Biocleanse Allografts For ACL Reconstruction
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