Evaluation of Biocleanse Allografts For ACL Reconstruction

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

Detailed Description
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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.

Official Title
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Evaluation of Biocleanse Patellar Tendon Allografts For The Reconstruction of Anterior Cruciate Ligaments: A Prospective, Randomized Investigation

Conditions
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Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: ACL reconstruction control
* Procedure: ACL Biocleanse, surgical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ACL reconstruction Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ACL reconstruction control<br>The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts. | Procedure: ACL reconstruction control<br>* The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.<br>* Other names: Standard ACL allograft;|
| Experimental: ACL Biocleanse, surgical<br>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<br>* The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.<br>* Other names: BioCleanse™ process;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 month period |