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

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ClinicalTrials.gov Identifier: NCT00793104
Recruitment Status : Terminated (Slow enrolment & potential regulatory changes for allograft in cartilage repair)
First Posted : November 19, 2008
Results First Posted : December 25, 2013
Last Update Posted : December 25, 2013
Sponsor:
Information provided by (Responsible Party):
RTI Surgical

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 19, 2008
Results First Submitted Date  ICMJE July 12, 2013
Results First Posted Date  ICMJE December 25, 2013
Last Update Posted Date December 25, 2013
Study Start Date  ICMJE November 2008
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
The Knee Injury and Osteoarthritis Outcome Score (KOOS) at 24 Months [ Time Frame: 24 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
Decreased in preoperative pain as measured by the KOOS pain subscale [ Time Frame: baseline, 3 months, 6 months, 12 months, 24 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2013)
  • Current Health Assessment [ Time Frame: 24 months, MRI only at 12 and 24 months ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the CR Plug (Allograft) for the Treatment of a Cartilage Injury in the Knee.
Official Title  ICMJE Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle
Brief Summary Determine the ability of the allograft plug for the treatment of a cartilage injury in the knee
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Injury
Intervention  ICMJE Procedure: Placement of allograft CR Plug in primary injury site
Core defect and implant allograft CR plug
Study Arms  ICMJE CR Plug
Placement of allograft CR Plug in primary injury site
Intervention: Procedure: Placement of allograft CR Plug in primary injury site
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 2, 2012)
10
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2008)
20
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00793104
Other Study ID Numbers  ICMJE CRP2008
WIRB # 20081109 ( Other Identifier: Western IRB )
St Francis IRB Project # 571 ( Other Identifier: St. Francis IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RTI Surgical
Study Sponsor  ICMJE RTI Surgical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account RTI Surgical
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP