Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site From an Autograft in the Knee. (CRB)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00821873
First received: January 12, 2009
Last updated: November 6, 2013
Last verified: November 2013
  Purpose

The main objective of this study is to test the ability of an allograft plug to provide a successful repair of an osteochondral defect left at the harvest site during OATS procedure.


Condition Intervention Phase
Knee Injury
Other: CR Plug
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: 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 Defects Created at the Harvest Site During the Osteochondral Autograft Transfer System(OATS)Procedure

Resource links provided by NLM:


Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • MRI to Evaluate Success of Outcome. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    The CR-Plug to repair the harvest site defect left during the OATS procedure, the harvest site will be evaluated at 24 months post-operatively.

    The MRI scans were evaluated by a radiologist for several categories and these were then scored and transformed to an index, resulting in an outcome score ranging from 0-100 In this scale, 0 is the worst possible and 100 is the best possible score.



Enrollment: 9
Study Start Date: December 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CR Plug BackFill
Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
Other: CR Plug
CR Plug will be placed in the harvest site

Detailed Description:

The objective of this study is to determine how effective a plug made out of human bone (called "CR-Plug") will be in the treatment at the site that your tissue was removed, thereby filling the hole created during the OATS procedure.At the present, OATS is used for knee articular cartilage defects or injuries smaller than the size of a dime (or 2.5 cm2) in the areas that bear weight have been commonly treated by using a tiny cylinder of the subjects' own tissue called an osteochondral autograft (OATS).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are male or female at least 18 years of age and up to 55 years of age
  • Must be skeletally mature
  • Have a grade III or IV lesion in femoral condyle

Exclusion Criteria:

  • Skeletally immature
  • Osteoarthritic knees, osteonecrotic knees, osteophyte formation
  • Use of any investigational therapy within thirty (30) days prior to the first visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821873

Locations
United States, Alabama
American Sports Medicine Institute
Birmingham, Alabama, United States, 35205
United States, Arizona
The Orthopedic Clinic Assoc
Phoenix, Arizona, United States, 85016
United States, Colorado
Colorado Orthopedic Consultants
Englewood, Colorado, United States, 80110
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43221
Sponsors and Collaborators
RTI Biologics
Investigators
Principal Investigator: Thomas Carter, MD The Orthopedic Clinic, Assoc
Principal Investigator: David Flanigan, MD The Ohio State Univesity
Principal Investigator: Phillip Stull, MD Colorado Orthopedic Consultants
Principal Investigator: Jeffrey Dugas, MD American Sports Medicine Institute
  More Information

No publications provided

Responsible Party: RTI Biologics
ClinicalTrials.gov Identifier: NCT00821873     History of Changes
Other Study ID Numbers: CRB2008, WIRB #20080290
Study First Received: January 12, 2009
Results First Received: August 1, 2013
Last Updated: November 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by RTI Biologics:
Cartilage injury
OATS
Knee injury
allograft
autograft

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on July 29, 2014