Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
245 participants
INTERVENTIONAL
2010-05-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NeoCart
Autologous cartilagenous tissue implant
NeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.
Microfracture
surgical intervention
Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
Interventions
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NeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.
Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.
Eligibility Criteria
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Inclusion Criteria
* symptomatic articular cartilage lesion of the femur and/or trochlea
Exclusion Criteria
* arthritis
* clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
18 Years
59 Years
ALL
No
Sponsors
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Histogenics Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Andrea Belschner
Role: STUDY_DIRECTOR
Histogenics Corporation
Locations
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Tucson Orthopaedic Institute
Tucson, Arizona, United States
Grossmont Orthopedic Medical Group
La Mesa, California, United States
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
Orange, California, United States
UCSF Mission Bay Orthopaedic Institute
San Francisco, California, United States
Southern California Orthopedic Research and Education
Van Nuys, California, United States
Colorado University Boulder
Boulder, Colorado, United States
Steadman Hawkins Clinic - Denver
Denver, Colorado, United States
Shrock Clinical Research
Fort Lauderdale, Florida, United States
Jewett Orthopaedic Clinic
Orlando, Florida, United States
Optim Healthcare
Savannah, Georgia, United States
St. Lukes Medical Center
Boise, Idaho, United States
Rush University Medical Center
Chicago, Illinois, United States
OrthoIndy
Greenwood, Indiana, United States
Ochsner Clinic Sports Medicine
New Orleans, Louisiana, United States
Orthopaedic Associates
Portland, Maine, United States
Harvard Vanguard Medical Associates
West Roxbury, Massachusetts, United States
William Beaumont Hospital
Royal Oak, Michigan, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Alpine Orthopedics & Sports Medicine
Bozeman, Montana, United States
University of New Mexico
Albuquerque, New Mexico, United States
Hospital for Special Surgery
New York, New York, United States
Duke Sports Medicine
Durham, North Carolina, United States
Ohio State University - Department of Sports Medicine
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
The San Antonio Orthopaedic Group (TSAOG)
San Antonio, Texas, United States
The Orthopedic Specialty Hospital
Murray, Utah, United States
University of Washington
Seattle, Washington, United States
Simon Fraser Orthopaedic Fund
New Westminster, British Columbia, Canada
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada
Countries
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References
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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.
Crawford 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.
Related Links
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Histogenics WebSite
Other Identifiers
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8-01
Identifier Type: -
Identifier Source: org_study_id
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