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
|Condition or disease||Intervention/treatment||Phase|
|Knee Injury||Procedure: Placement of allograft CR Plug in primary injury site||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
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
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00793104
|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|
|Indianapolis, Indiana, United States, 46237|
|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|