Evaluation of Biocleanse Allografts For ACL Reconstruction

University of Florida67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anterior Cruciate Ligament Tear

Interventions

ACL reconstruction controlPROCEDURE

The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

ACL Biocleanse, surgicalPROCEDURE

The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ACL reconstruction Exclusion Criteria: * none

Locations (1)

UF Orthopedics and Sports Medicine Institute

Gainesville, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 month period

Data from ClinicalTrials.gov

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