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

NCT ID: NCT00821873

Last Updated: 2013-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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).

Conditions

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Knee Injury

Keywords

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Cartilage injury OATS Knee injury allograft autograft

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CR Plug BackFill

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

Group Type EXPERIMENTAL

CR Plug

Intervention Type OTHER

CR Plug will be placed in the harvest site

Interventions

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CR Plug

CR Plug will be placed in the harvest site

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RTI Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Carter, MD

Role: PRINCIPAL_INVESTIGATOR

The Orthopedic Clinic, Assoc

David Flanigan, MD

Role: PRINCIPAL_INVESTIGATOR

The Ohio State Univesity

Phillip Stull, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Orthopedic Consultants

Jeffrey Dugas, MD

Role: PRINCIPAL_INVESTIGATOR

American Sports Medicine Institute

Locations

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American Sports Medicine Institute

Birmingham, Alabama, United States

Site Status

The Orthopedic Clinic Assoc

Phoenix, Arizona, United States

Site Status

Colorado Orthopedic Consultants

Englewood, Colorado, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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WIRB #20080290

Identifier Type: OTHER

Identifier Source: secondary_id

CRB2008

Identifier Type: -

Identifier Source: org_study_id