NOVOCART®3D for Treatment of Articular Cartilage of the Knee
- Conditions
- Articular Cartilage of the Femoral Condyle Between 2-6cm2
- Interventions
- Procedure: MicrofractureBiological: NOVOCART 3D
- Registration Number
- NCT01957722
- Lead Sponsor
- Aesculap Biologics, LLC
- Brief Summary
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.
- Detailed Description
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 233
- Greater than 18 years old
- Isolated articular cartilage lesions on the femoral condyle 2-6 cm2
- Minimum score on the KOOS questionnaire
- Instability of the knee joint
- Arthritis
- Autoimmune disease
- Immune suppression
- Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline)
- Bone disease
- Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Microfracture Microfracture considered a typical treatment for articular cartilage repair NOVOCART 3D NOVOCART 3D Scaffold assisted autologous chondrocyte Implant
- Primary Outcome Measures
Name Time Method Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain 24 months post treatment As measured by a change in KOOS (pain subdomain) score at 24 months from baseline
Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain 24 months post treatment As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (35)
Grossmont Orthopaedic Medical Group
🇺🇸La Mesa, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Stanford Medicine
🇺🇸Redwood, California, United States
Cu Sports Medicine
🇺🇸Denver, Colorado, United States
Yampa Valley Medical Center
🇺🇸Steamboat Springs, Colorado, United States
Tenet Florida Physician Services
🇺🇸Boca Raton, Florida, United States
Paley Orthopedic and Spine Institute
🇺🇸West Palm Beach, Florida, United States
Saint Alphonsus Medical Group
🇺🇸Meridian, Idaho, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Northshore University Health System
🇺🇸Evanston, Illinois, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Ochsner Health System
🇺🇸New Orleans, Louisiana, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Tria Orthopaedic Center
🇺🇸Bloomington, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Missouri Healthcare
🇺🇸Columbia, Missouri, United States
Mount Sinai Faculty Practice Associates
🇺🇸New York, New York, United States
Plancher Orthopaedics & Sports Medicine
🇺🇸New York, New York, United States
Long Island Bone and Joint Llp
🇺🇸Port Jefferson, New York, United States
Ohio State University Sports Medicine
🇺🇸Columbus, Ohio, United States
Tulsa Bone and Joint Associates
🇺🇸Tulsa, Oklahoma, United States
St. Luke'S University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Allegheny - Singer Research Institute
🇺🇸Pittsburgh, Pennsylvania, United States
Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
Alpine Orthopaedics
🇺🇸North Logan, Utah, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
The Orthopaedic Center of Central Virginia Inc
🇺🇸Lynchburg, Virginia, United States
Advanced Orthopaedics
🇺🇸Richmond, Virginia, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
Simon Fraser Orthopaedic Fund
🇨🇦Surrey, British Columbia, Canada
Dalhousie University
🇨🇦Halifax, Nova Scotia, Canada
St. Josephs Healthcare Hamilton
🇨🇦Hamilton, Ontario, Canada
Lawson Health Research Institute
🇨🇦London, Ontario, Canada