Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00187876
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2005-09-12
Brief Title:
Evaluation of Biocleanse Allografts For ACL Reconstruction
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments A Prospective Randomized Investigation
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None