Clinical Application of BioCleanse Meniscus (Meniscus)

April 10, 2017 updated by: RTI Surgical

Clinical Application of BioCleanse Meniscus Registry

This study will follow patients after routine surgery of a meniscal allograft transplant.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The purpose of this registry is to allow close monitoring of a subgroup of patients receiving the BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal Allograft transplant will be asked to join the registry. Outcomes will be measured by subjective subject questionnaires as well as X-rays and MRI.

Study Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • OrthoIndy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients, between the ages of 18 and 55 years, who have selected meniscal allograft transplantation (MAT) using BioCleanse allografts will be eligible to participate in the MAT registry.

Description

Inclusion Criteria:

  • All patients, up to 10 who have selected a BioCleanse Meniscus transplant

Exclusion Criteria:

  • Anyone not eligible for a meniscal transplant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 60 months
The score is an index score from 0 to 100, with 0 representing extreme problems and 100 representing no problems.
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Assessments
Time Frame: 12 months

MRI images were assessed for integration of the meniscal allograft transplant for integration of the anterior horn, body and posterior horn.

Images were also assessed for oedema in each of these 3 regions of the meniscus.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RTI Surgical

Investigators

  • Principal Investigator: Jack Farr, MD, OrthoIndy -Orthopaedic Research Foundation, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

April 14, 2008

First Submitted That Met QC Criteria

April 15, 2008

First Posted (Estimate)

April 16, 2008

Study Record Updates

Last Update Posted (Actual)

June 26, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BioMen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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