Clinical trial NCT01066702: Confirmatory Study of NeoCart in Knee Cartilage Repair
Official title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Articular Cartilage Defects in the Knee Joint
Lead sponsor: Histogenics Corporation
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* greater than 18 years old
* symptomatic articular cartilage lesion of the femur and/or trochlea

Exclusion Criteria:

* prior surgical intervention other than debridement
* arthritis
* clinically significant or symptomatic vascular or neurologic disorder of the lower extremities

Primary outcomes:
measure: 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)
timeFrame: one year
Secondary outcomes:
measure: Repair cartilage structure as measured by magnetic resonance imaging (MRI)
timeFrame: one year
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: La Mesa
country: United States
facility: Grossmont Orthopedic Medical Group
state: California
city: Orange
country: United States
facility: Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
state: California
city: San Francisco
country: United States
facility: UCSF Mission Bay Orthopaedic Institute
state: California
city: Van Nuys
country: United States
facility: Southern California Orthopedic Research and Education
state: California
city: Boulder
country: United States
facility: Colorado University Boulder
state: Colorado
city: Denver
country: United States
facility: Steadman Hawkins Clinic - Denver
state: Colorado
city: Fort Lauderdale
country: United States
facility: Shrock Clinical Research
state: Florida
city: Orlando
country: United States
facility: Jewett Orthopaedic Clinic
state: Florida
city: Savannah
country: United States
facility: Optim Healthcare
state: Georgia
city: Boise
country: United States
facility: St. Lukes Medical Center
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Greenwood
country: United States
facility: OrthoIndy
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic Sports Medicine
state: Louisiana
city: Portland
country: United States
facility: Orthopaedic Associates
state: Maine
city: West Roxbury
country: United States
facility: Harvard Vanguard Medical Associates
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Bozeman
country: United States
facility: Alpine Orthopedics & Sports Medicine
state: Montana
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Durham
country: United States
facility: Duke Sports Medicine
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University - Department of Sports Medicine
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: The San Antonio Orthopaedic Group (TSAOG)
state: Texas
city: Murray
country: United States
facility: The Orthopedic Specialty Hospital
state: Utah
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: New Westminster
country: Canada
facility: Simon Fraser Orthopaedic Fund
state: British Columbia
city: London
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
Study officials:
affiliation: Histogenics Corporation
name: Andrea Belschner
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.