Study Stopped
company dissolution
Confirmatory Study of NeoCart in Knee Cartilage Repair
A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
1 other identifier
interventional
245
2 countries
31
Brief Summary
This confirmatory study is a prospective randomized trial comparing the efficacy and safety of an autologous chondrocyte tissue implant (NeoCart) to the surgical intervention microfracture in the treatment of cartilage defects in the knee.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2010
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedMarch 29, 2019
December 1, 2018
8.8 years
February 8, 2010
March 27, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The change of physical functioning and pain as assessed by patient reported outcome measures (Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score)
one year
Secondary Outcomes (1)
Repair cartilage structure as measured by magnetic resonance imaging (MRI)
one year
Study Arms (2)
NeoCart
EXPERIMENTALAutologous cartilagenous tissue implant
Microfracture
ACTIVE COMPARATORsurgical intervention
Interventions
implantation of an cartilagenous tissue implant derived from the patients own cells.
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
Eligibility Criteria
You may qualify if:
- greater than 18 years old
- symptomatic articular cartilage lesion of the femur and/or trochlea
You may not qualify if:
- prior surgical intervention other than debridement
- arthritis
- clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
Grossmont Orthopedic Medical Group
La Mesa, California, 91942, United States
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
Orange, California, 92868, United States
UCSF Mission Bay Orthopaedic Institute
San Francisco, California, 94158, United States
Southern California Orthopedic Research and Education
Van Nuys, California, 91405, United States
Colorado University Boulder
Boulder, Colorado, 80304, United States
Steadman Hawkins Clinic - Denver
Denver, Colorado, 80111, United States
Shrock Clinical Research
Fort Lauderdale, Florida, 33316, United States
Jewett Orthopaedic Clinic
Orlando, Florida, 32822, United States
Optim Healthcare
Savannah, Georgia, 31405, United States
St. Lukes Medical Center
Boise, Idaho, 83702, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OrthoIndy
Greenwood, Indiana, 46143, United States
Ochsner Clinic Sports Medicine
New Orleans, Louisiana, 70121, United States
Orthopaedic Associates
Portland, Maine, 04102, United States
Harvard Vanguard Medical Associates
West Roxbury, Massachusetts, 02467, United States
William Beaumont Hospital
Royal Oak, Michigan, 48073, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Alpine Orthopedics & Sports Medicine
Bozeman, Montana, 59718, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Hospital for Special Surgery
New York, New York, 10021, United States
Duke Sports Medicine
Durham, North Carolina, 27710, United States
Ohio State University - Department of Sports Medicine
Columbus, Ohio, 43221, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
The San Antonio Orthopaedic Group (TSAOG)
San Antonio, Texas, 78216, United States
The Orthopedic Specialty Hospital
Murray, Utah, 84107, United States
University of Washington
Seattle, Washington, 98195, United States
Simon Fraser Orthopaedic Fund
New Westminster, British Columbia, Canada
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada
Related Publications (2)
Crawford DC, DeBerardino TM, Williams RJ 3rd. NeoCart, an autologous cartilage tissue implant, compared with microfracture for treatment of distal femoral cartilage lesions: an FDA phase-II prospective, randomized clinical trial after two years. J Bone Joint Surg Am. 2012 Jun 6;94(11):979-89. doi: 10.2106/JBJS.K.00533.
PMID: 22637204BACKGROUNDCrawford DC, Heveran CM, Cannon WD Jr, Foo LF, Potter HG. An autologous cartilage tissue implant NeoCart for treatment of grade III chondral injury to the distal femur: prospective clinical safety trial at 2 years. Am J Sports Med. 2009 Jul;37(7):1334-43. doi: 10.1177/0363546509333011. Epub 2009 May 15.
PMID: 19448048BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Andrea Belschner
Histogenics Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 10, 2010
Study Start
May 1, 2010
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
March 29, 2019
Record last verified: 2018-12