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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00793104
First received: November 17, 2008
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Knee Injury
 Procedure: Placement of allograft CR Plug in primary injury site
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/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 Focal Cartilage Lesions in the Femoral Condyle

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • Decreased in preoperative pain as measured by the KOOS pain subscale [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in quality of life scores, KOOS, improvement in Lysholm with Tegner, IKDC assessment forms, IKDC objective evaluation, MRI results, [ Time Frame: baseline, 3 months, 6 months, 12 months and 24 months, MRI only at 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
CR Plug
Allograft
 Procedure: Placement of allograft CR Plug in primary injury site
Core defect and implant allograft CR plug

Detailed Description:

The main objective of this study is to test the ability of an allograft plug to provide successful repair to a cartilage injury in the knee less than 2.5 cm squared.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Skeletally mature
  • Have one symptomatic score ICRS grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the MFC or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793104

Locations
United States, California
Kerlan Jobe Orthopaedic Clinic
Los Angeles, California, United States, 90045
United States, Colorado
Colorado Orthopedic Consultants
Denver, Colorado, United States, 80012
United States, Indiana
OrthoIndy, Inc
Indianapolis, Indiana, United States, 46237
Sponsors and Collaborators
RTI Biologics
Investigators
Principal Investigator: Jack Farr, MD, PhD OrthoIndy, Inc
Principal Investigator: Ralph A Gambardella, MD Kerlan Jobe Orthopaedic Clinic
Principal Investigator: Stewart Weinerman, MD Colorado Orthopedic Consultants
  More Information

Additional Information:
Click here to find more information from OrthoIndy  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: RTI Biologics
ClinicalTrials.gov Identifier: NCT00793104     History of Changes
Other Study ID Numbers: CRP2008, WIRB # 20081109, St Francis IRB Project # 571
Study First Received: November 17, 2008
Last Updated: July 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by RTI Biologics:
allograft
knee injury
cartilage injury
Osteochondral defects in the articular femoral cartilage

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

ClinicalTrials.gov processed this record on May 22, 2013