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

Primary Purpose

Knee Injury

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

CR Plug

About this trial

This is an interventional treatment trial for Knee Injury focused on measuring Cartilage injury, OATS, Knee injury, allograft, autograft

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

American Sports Medicine Institute
The Orthopedic Clinic Assoc
Colorado Orthopedic Consultants
Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CR Plug BackFill

Arm Description

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site

Outcomes

Primary Outcome Measures

MRI to Evaluate Success of Outcome.

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00821873

First Posted

January 12, 2009

Last Updated

November 6, 2013

Sponsor

RTI Surgical

1. Study Identification

Unique Protocol Identification Number

NCT00821873

Brief Title

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

Acronym

CRB

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RTI Surgical

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Injury

Keywords

Cartilage injury, OATS, Knee injury, allograft, autograft

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CR Plug BackFill

Arm Type

Experimental

Arm Description

Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site

Intervention Type

Other

Intervention Name(s)

CR Plug

Intervention Description

CR Plug will be placed in the harvest site

Primary Outcome Measure Information:

Title

MRI to Evaluate Success of Outcome.

Description

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Carter, MD

Organizational Affiliation

The Orthopedic Clinic, Assoc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

David Flanigan, MD

Organizational Affiliation

The Ohio State Univesity

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Phillip Stull, MD

Organizational Affiliation

Colorado Orthopedic Consultants

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jeffrey Dugas, MD

Organizational Affiliation

American Sports Medicine Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

American Sports Medicine Institute

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

The Orthopedic Clinic Assoc

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

Colorado Orthopedic Consultants

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80110

Country

United States

Facility Name

Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43221

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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