DeNovo NT Natural Tissue Graft Stratified Knee Study
- Conditions
- Defect of Articular CartilageKnee Injuries
- Interventions
- Other: Particulated Juvenile Articular Cartilage
- Registration Number
- NCT01670617
- Lead Sponsor
- Zimmer Orthobiologics, Inc.
- Brief Summary
The purpose of this study is to evaluate the long-term relief of pain and return to function for patients receiving DeNovo NT for cartilage lesions in the knee. DeNovo NT is a marketed product and has been used in more than 7,500 patients over the last 7 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DeNovo NT Graft Particulated Juvenile Articular Cartilage DeNovo NT Graft stratified by lesion location - femur or patella
- Primary Outcome Measures
Name Time Method Improvement in KOOS scores Between baseline and 24 months post surgery Improvement in Knee Injury and Osteoarthritis Outcomes Survey (KOOS) scores
- Secondary Outcome Measures
Name Time Method Incidence and time to reoperation/revision 5 years Mean IKDC Knee Examination grades Annually to 5 years post surgery MRI Evaluation Preop, 12 Months and 24 Months post surgery Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
Incidence of adverse events Annually to 5 years post surgery X-ray Evaluation Preop, 12 months and 24 months post surgery X-ray evaluation of joint narrowing, and osteophyte and cyst formation
Trial Locations
- Locations (18)
Tulane University Medical Center
🇺🇸New Orleans, Louisiana, United States
Kerlan Jobe Orthopaedics
🇺🇸Los Angeles, California, United States
Naval Medical Center San Deigo
🇺🇸San Deigo, California, United States
Andrews Institute for Orthopaedics & Sports Medicine
🇺🇸Gulf Breeze, Florida, United States
Colorado Orthopedic Consultants
🇺🇸Aurora, Colorado, United States
Emory Spine & Sports Medicine Center
🇺🇸Atlanta, Georgia, United States
TRIA Orthopaedic Center
🇺🇸Bloomington, Minnesota, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Minnesota Orthopedic Sports Medicine Institute at Twin Cities Orthopedics
🇺🇸Edina, Minnesota, United States
A.T. Still University of Health Sciences
🇺🇸Kirksville, Missouri, United States
University Orthopaedic Associates
🇺🇸Somerset, New Jersey, United States
New Mexico Orthopaedic Consultants
🇺🇸Albuquerque, New Mexico, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
San Antonio Military Medical Center
🇺🇸San Antonio, Texas, United States
Madigan Army Medical Center
🇺🇸Tacoma, Washington, United States
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Women's College Hospital
🇨🇦Toronoto, Canada