Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.

This study is currently recruiting participants.

Verified by RTI Biologics, September 2009

First Received: November 17, 2008 Last Updated: September 10, 2009 History of Changes

Sponsor:	RTI Biologics
Information provided by:	RTI Biologics
ClinicalTrials.gov Identifier:	NCT00793104

Purpose

Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee

Condition	Intervention	Phase
Knee Injury	Procedure: cartilage repair with allograft plug	Phase III

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle

Resource links provided by NLM:

MedlinePlus related topics: Knee Injuries and Disorders

U.S. FDA Resources

Further study details as provided by RTI Biologics:

Primary Outcome Measures:

Decreased in preoperative pain as measured by the KOOS pain subscale [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Improvement in quality of life scores, KOOS, improvement in Lysholm with Tegner, IKDC assessment forms, IKDC objective evaluation, MRI results, [ Time Frame: baseline, 3 months, 6 months, 12 months and 24 months, MRI only at 12 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Core cartilage defect and implant allograft CR Plug

Detailed Description:

The main objective of this study is to test the ability of an allograft plug to provide successful repair to a cartilage injury in the knee less than 2.5 cm squared.

Eligibility

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

Criteria

Inclusion Criteria:

18 years of age or older
Skeletally mature
Have one symptomatic score ICRS grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the MFC or LFC. Symptoms must include pain, pain with weight bearing and squatting, locking of joints, and/or swelling
Functional meniscal tissue (defined as 5 mm or more width)
A score of = or greater than 4 on the VAS questionnaire

Exclusion Criteria:

Associated tibial or patellar articular cartilage defect greater than 2 ICRS
Osteoarthritis of either knee
Mechanical axis malalignment of greater than 5 degrees
Patellofemoral incongruity of Merchant view
One or more multiple defects greater than 2.5 cm
Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
Ligament treatments in the affected knee within one yer prior to current study
Previous surgical meniscus treatments in the affected knee in the last 6 months
Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
Use of any investigational therapy with in 30 days prior to the first visit
Corticosteroid or viscosupplementation within the past 3 months
A score of 3 or less on the VAS Questionnaire
Active gout or pseudogout or systemic inflammatory condition

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793104

Locations

United States, California
Kerlan Jobe Orthopaedic Clinic	Recruiting
Los Angeles, California, United States, 90045
Contact: Karen Mohr 310-665-7200
Principal Investigator: Ralph A Gambardella, MD
United States, Colorado
Colorado Orthopedic Consultants	Recruiting
Denver, Colorado, United States, 80012
Contact: Heike Newman 303-695-6060 HeikeNewman@cocortho.com
Contact: Keiran Browner 303-695-6060
Principal Investigator: Stewart Weinerman, MD
United States, Indiana
OrthoIndy, Inc	Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Vicki Snodgrass 317-884-5230 vsnodgrass@orthoindy.com
Principal Investigator: Jack Farr, MD, PhD

Sponsors and Collaborators

RTI Biologics

Investigators

Principal Investigator:	Jack Farr, MD, PhD	OrthoIndy, Inc
Principal Investigator:	Ralph A Gambardella, MD	Kerlan Jobe Orthopaedic Clinic
Principal Investigator:	Stewart Weinerman, MD	Colorado Orthopedic Consultants

More Information

Additional Information:

Click here to find more information from OrthoIndy This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Regeneration Technologies ( Director of Clinical Projects )
Study ID Numbers:	CRP2008, WIRB # 20081109, St Francis IRB Project # 571
Study First Received:	November 17, 2008
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00793104 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by RTI Biologics:

allograft
knee injury
cartilage injury
Osteochondral defects in the articular femoral cartilage

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Knee Injuries
Leg Injuries

ClinicalTrials.gov processed this record on March 18, 2010