Clinical Application of BioCleanse Meniscus - Full Text View

Purpose

Meniscal Allograft transplantation using grafts sterilized through BioCleanse system.

Condition	Intervention	Phase
Damaged Meniscus	Other: BioCleanse Meniscus	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Efficacy Study

Official Title:	Clinical Application of BioCleanse Meniscus Registry

Further study details as provided by RTI Biologics:

Primary Outcome Measures:

Subjective subject questionnaire scores as well as X-ray and MRI evaluations [ Time Frame: Subject questionnaires at 4 weeks, 6 months, 12 months, 24 months and 60 months. X-rays at 4 weeks and 12 months. MRI at 6 months (optional) and 12 months. ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Meniscus Allograft sterilized with the BioCleanse system

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Anyone not eligible for a meniscal transplant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659880

Contacts


Contact: Vicki Snodgrass, CCRC	317-884-5230	Vsnodgrass@orthoindy.com

Locations


United States, Indiana
	OrthoIndy	Recruiting
	Indianapolis, Indiana, United States, 46237
	Contact: Vicki Snodgrass, CCRC 317-884-5230 Vsnodgrass@orthoindy.com
	Principal Investigator: Jack Farr, MD

Sponsors and Collaborators

RTI Biologics

Investigators


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

More Information

Responsible Party:	Regeneration Technologies, Inc ( Robin Waite, Clinical Project Manager )
Study ID Numbers:	BioMen
First Received:	April 14, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00659880
Health Authority:	United States: Institutional Review Board

Keywords provided by RTI Biologics:

Meniscus transplant

Meniscal allograft

MAT

Knee

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	RTI Biologics
Information provided by:	RTI Biologics
ClinicalTrials.gov Identifier:	NCT00659880