Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects

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:
NCT00984594
First received: September 24, 2009
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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 of smaller, focal defects (like the injury the patient has to their knee).


Condition Intervention Phase
Knee Injury
Other: Primary injury site
Other: Backfill site
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Osteochondral Defects in High-Load-Bearing Region and Low-Load-Bearing Region of the Femoral Condyle

Resource links provided by NLM:


Further study details as provided by RTI Biologics:

Primary Outcome Measures:
  • Knee Injury and Osteoarthritis Outcome Score (KOOS [ 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 (CHA) [ Time Frame: 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.

  • IKDC Assessment [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The International Knee Documentation Committee (IKDC) scores from 24 months are shown. The IKDC is an index score from 0 to 100, with 100 being the best possible score,

  • Magnetic Resonance Imaging (MRI) Results [ 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.

  • Lysholm Score at 24 Months [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The Lysholm scores from the 24-month exams are shown. The Lysholm score is an indexed score of knee functional ability, with 0 being the worst score and 100 being the best score, indicating no limitations in activity/function.


Enrollment: 4
Study Start Date: January 2009
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Primary injury site
CR-Plug will be placed in the site of the primary injury
Other: Primary injury site
Autograft will be placed in the primary defect site.
Backfill site
Autograft will be placed in the site of the primary injury; CR Plug will be placed in the harvest site
Other: Backfill site
Autograft will be placed in the primary defect site; CR-Plug will be placed in the harvest site.

Detailed Description:

The main objective of this double arm study is to test the ability of an allograft plug to provide "successful" repair of less than (<) 2.5 cm2 osteochondral defect in a low-load-bearing femoral condyle region, and a high-load-bearing femoral-condyle region.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18 to 55 years
  • skeletally mature
  • Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
  • Functional meniscal tissue (defined as 5 mmor greater)
  • 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 on 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 year prior to current study
  • Previous surgical meniscus treatment 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 within 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
  • Microfracture less than one year prior to current study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984594

Locations
United States, Kentucky
Ellis and Badenhausen Orthopaedics, PSC
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
RTI Biologics
Investigators
Principal Investigator: Akbar Nawab, MD Ellis and Badenhausen Orthopaedics, PSC
  More Information

No publications provided

Responsible Party: RTI Biologics
ClinicalTrials.gov Identifier: NCT00984594     History of Changes
Other Study ID Numbers: CR2008
Study First Received: September 24, 2009
Results First Received: July 10, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by RTI Biologics:
allograft
knee injury
cartilage injury

Additional relevant MeSH terms:
Knee Injuries
Wounds and Injuries
Osteochondrosis
Leg Injuries
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 15, 2014