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

November 6, 2013 updated by: RTI Surgical

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Phase 3

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
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • American Sports Medicine Institute
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • The Orthopedic Clinic Assoc
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Colorado Orthopedic Consultants
    • Ohio
      • Columbus, Ohio, United States, 43221
        • Ohio State University

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

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI to Evaluate Success of Outcome.
Time Frame: 24 months

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.
24 months

Collaborators and Investigators

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

Sponsor

RTI Surgical

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

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

December 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

January 12, 2009

First Submitted That Met QC Criteria

January 13, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 6, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRB2008
  • WIRB #20080290 (Other Identifier: Western IRB)

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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