Evaluation of a Composite Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Knee Osteochondral Defects
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).
|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|
- 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.
- 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.
|Study Start Date:||January 2009|
|Study Completion Date:||February 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984594
|United States, Kentucky|
|Ellis and Badenhausen Orthopaedics, PSC|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Akbar Nawab, MD||Ellis and Badenhausen Orthopaedics, PSC|