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

This study has been terminated.
(Slow enrolment & potential regulatory changes for allograft in cartilage repair)
Sponsor:
Information provided by (Responsible Party):
RTI Biologics
ClinicalTrials.gov Identifier:
NCT00793104
First received: November 17, 2008
Last updated: November 6, 2013
Last verified: November 2013
  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:


Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The outcome at 24 months as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS). Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.


Secondary Outcome Measures:
  • Current Health Assessment [ Time Frame: 24 months, MRI only at 12 and 24 months ] [ Designated as safety issue: No ]
    Evaluation on the Current Health Assessment at 24 months. Scores are transformed to a 0-100 scale, with zero representing a self-graded perception of extremely poor health and 100 representing no health problems. Scores between 0 and 100 represent the percentage of total possible score achieved.

  • Lysholm With Tegner Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Tegner activity scale was designed as a score of activity level to complement other functional scores (eg the Lysholm knee score) for patients with ligamentous injuries. The instrument scores a person's activity level between 0 and 100 where 0 is 'on sick leave/disability' and 100 is 'participation in competitive sports at a full, unhindered level.

  • International Knee Documentation Committee (IKDC) at 24 Months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The International Knee Documentation Committee scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic scales and generic measures. Scores between 0 and 100 represent the percentage of total possible score achieved.

  • MRI Evaluation Score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    MRI images were graded by a radiologist with regard to the incorporation of the CR graft in both the cancellous and cortical portions of the bone at the graft site. The raw scores were converted to an index scale form 0 to 100, with 0 representing failure of the graft to incorporate and 100 representing complete incorporation of the graft.


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
Placement of allograft CR Plug in primary injury site
Procedure: Placement of allograft CR Plug in primary injury site
Core defect and implant allograft CR plug

Detailed Description:

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.

  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 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
  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:
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
Results First Received: July 12, 2013
Last Updated: November 6, 2013
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
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on April 23, 2014