Evaluation of Biocleanse Allografts For ACL Reconstruction
NCT ID: NCT00187876
Last Updated: 2014-03-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2004-02-29
2012-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.
ACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
ACL Biocleanse, surgical
The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Interventions
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ACL reconstruction control
The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
55 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Peter A. Indelicato, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Orthopedics and Sports Medicine Institute
Gainesville, Florida, United States
Countries
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Other Identifiers
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566-2003
Identifier Type: -
Identifier Source: org_study_id
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