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Sponsored by: |
RTI Biologics |
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Information provided by: | RTI Biologics |
ClinicalTrials.gov Identifier: | NCT00793104 |
Determine the ability of the allograft plug for the repair of a articular cartilage defect in the knee.
Condition | Intervention | Phase |
---|---|---|
Knee Injury |
Procedure: cartilage repair with allograft plug |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Double Blind (Subject, Outcomes Assessor), Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Composite of Cancellous and Demineralized Bone Plug (CR-Plug) for Repair of Focal Cartilage Lesions in the Femoral Condyle |
Estimated Enrollment: | 20 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
The main objective of this study is to test the ability of an allograft plug composed of cancellous bone with a demineralized cortical cap to provide repair of a focal chondral or osteochondral defect less than 2.5cm in the articular cartilage (MFC and LFC)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Kerlan Jobe Orthopaedic Clinic | Recruiting |
Los Angeles, California, United States, 90045 | |
Contact: Karen Mohr 310-665-7129 | |
Principal Investigator: Ralph A Gambardella, MD | |
United States, Indiana | |
OrthoIndy, Inc | Recruiting |
Indianapolis, Indiana, United States, 46237 | |
Contact: Vicki Snodgrass 317-884-5230 vsnodgrass@orthoindy.com | |
Principal Investigator: Jack Farr, MD, PhD |
Principal Investigator: | Jack Farr, MD, PhD | OrthoIndy, Inc |
Principal Investigator: | Ralph A Gambardella, MD | Kerlan Jobe Orthopaedic Clinic |
Responsible Party: | Regeneration Technologies ( Robin Waite, Director of Clinical Projects ) |
Study ID Numbers: | CRP2008, WIRB # 20081109, St Francis IRB Project # 571 |
Study First Received: | November 17, 2008 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00793104 |
Health Authority: | United States: Institutional Review Board |
cartilage defect knee injury cartilage injury |
cartilage repair Chondral femoral articular femoral cartilage defects Osteochondral defects in the articular femoral cartilage |
Wounds and Injuries Disorders of Environmental Origin Knee Injuries Leg Injuries |