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

NCT ID: NCT00793104

Last Updated: 2013-12-25

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2012-03-31

Brief Summary

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

Detailed Description

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The specific aim in this study is to assess the ability of the CR-Plug to treat osteochondral focal defects of less than 2.5 cm squared at high-load-bearing femoral condyle.

Conditions

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Knee Injury

Keywords

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

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

Placement of allograft CR Plug in primary injury site

Group Type OTHER

Placement of allograft CR Plug in primary injury site

Intervention Type PROCEDURE

Core defect and implant allograft CR plug

Interventions

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Placement of allograft CR Plug in primary injury site

Core defect and implant allograft CR plug

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older
* Skeletally mature
* Have one symptomatic score International Cartilage Repair Score (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle (MFC) or Lateral Femoral Condyle (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
Minimum Eligible Age

18 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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Jack Farr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

OrthoIndy, Inc

Ralph A Gambardella, MD

Role: PRINCIPAL_INVESTIGATOR

Kerlan Jobe Orthopaedic Clinic

Stewart Weinerman, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Orthopedic Consultants

Locations

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Kerlan Jobe Orthopaedic Clinic

Los Angeles, California, United States

Site Status

Colorado Orthopedic Consultants

Denver, Colorado, United States

Site Status

OrthoIndy, Inc

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Related Links

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http://www.orthoindy.com

Click here to find more information from OrthoIndy

Other Identifiers

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WIRB # 20081109

Identifier Type: OTHER

Identifier Source: secondary_id

St Francis IRB Project # 571

Identifier Type: OTHER

Identifier Source: secondary_id

CRP2008

Identifier Type: -

Identifier Source: org_study_id