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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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).

Detailed Summary: 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.
Sponsor: RTI Surgical

Current Primary Outcome: Knee Injury and Osteoarthritis Outcome Score (KOOS [ 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: Decrease in preoperative pain as measured by the Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale [ Time Frame: 3, 6, 12, 24 months ]

Current Secondary Outcome:

  • Current Health Assessment (CHA) [ Time Frame: 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.
  • IKDC Assessment [ Time Frame: 24 months ]
    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 ]
    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 ]
    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.


Original Secondary Outcome:

  • Improvement in quality of life scores [ Time Frame: 3, 6, 12, 24 months ]
  • KOOS [ Time Frame: 3, 6, 12, 24 months ]
  • Improvement in Lysholm with Tegner [ Time Frame: 3, 6, 12, 24 months ]
  • International Knee Documentation Committee (IKDC) assessment forms [ Time Frame: 3, 6, 12, 24 months ]
  • IKDC objective evaluation [ Time Frame: 3, 6, 12, 24 months ]
  • Magnetic Resonance Imaging (MRI) Results [ Time Frame: 3, 6, 12, 24 months ]


Information By: RTI Surgical

Dates:
Date Received: September 24, 2009
Date Started: January 2009
Date Completion:
Last Updated: May 22, 2014
Last Verified: May 2014