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Completed

NCT Number: NCT00187876

Evaluation of Biocleanse Allografts For ACL Reconstruction

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

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Key information

Conditions

Anterior Cruciate Ligament Tear Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UF Orthopedics and Sports Medicine Institute

Gainesville, Florida, 32611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ACL reconstruction

Exclusion criteria

  • none

Treatment and study plan

ACL reconstruction control

Procedure

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

Other names: Standard ACL allograft

ACL Biocleanse, surgical

Procedure

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

Other names: BioCleanse™ process

Primary outcomes

  1. International Knee Documentation Committee (IKDC) Form

    Time frame: 24 month period

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2012
Study completion
2012
First posted
Sep 16, 2005
Registry last updated
Mar 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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