This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 3 of 4 for:    cartilage implant | Canada, Ontario

Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: June 30, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Articular Cartilage Defects in the Knee Joint Biological: NeoCart Procedure: Microfracture Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Randomized Comparison of NeoCart to Microfracture for the Repair of Articular Cartilage Injuries in the Knee

Further study details as provided by Histogenics Corporation:

Primary Outcome Measures:
  • 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) [ Time Frame: one year ]

Secondary Outcome Measures:
  • Repair cartilage structure as measured by magnetic resonance imaging (MRI) [ Time Frame: one year ]

Enrollment: 245
Study Start Date: May 2010
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NeoCart
Autologous cartilagenous tissue implant
Biological: NeoCart
implantation of an cartilagenous tissue implant derived from the patients own cells.
Active Comparator: Microfracture
surgical intervention
Procedure: Microfracture
holes are created in bone at the base of the defect bed to encourage growth of tissue within the defect bed.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066702

  Hide Study Locations
Locations
United States, Arizona
Mezona Orthopaedics
Gilbert, Arizona, United States, 85295
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, California
Grossmont Orthopedic Medical Group
La Mesa, California, United States, 91942
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI)
Orange, California, United States, 92868
UCSF Mission Bay Orthopaedic Institute
San Francisco, California, United States, 94158
Advanced Orthopedic Surgery Center
Temecula, California, United States
Southern California Orthopedic Research and Education
Van Nuys, California, United States, 91405
United States, Colorado
Colorado University Boulder
Boulder, Colorado, United States, 80304
Steadman Hawkins Clinic - Denver
Denver, Colorado, United States, 80111
United States, Florida
Shrock Clinical Research
Fort Lauderdale, Florida, United States, 33316
Jewett Orthopaedic Clinic
Orlando, Florida, United States, 32822
United States, Georgia
Optim Healthcare
Savannah, Georgia, United States, 31405
United States, Idaho
St. Lukes Medical Center
Boise, Idaho, United States, 83702
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
OrthoIndy
Greenwood, Indiana, United States, 46143
United States, Louisiana
Ochsner Clinic Sports Medicine
New Orleans, Louisiana, United States, 70121
United States, Maine
Orthopaedic Associates
Portland, Maine, United States, 04102
United States, Massachusetts
Harvard Vanguard Medical Associates
West Roxbury, Massachusetts, United States, 02467
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Montana
Alpine Orthopedics & Sports Medicine
Bozeman, Montana, United States, 59718
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, North Carolina
Duke Sports Medicine
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University - Department of Sports Medicine
Columbus, Ohio, United States, 43221
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States
United States, Texas
The San Antonio Orthopaedic Group (TSAOG)
San Antonio, Texas, United States, 78216
United States, Utah
The Orthopedic Specialty Hospital
Murray, Utah, United States, 84107
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Canada, British Columbia
Simon Fraser Orthopaedic Fund
New Westminster, British Columbia, Canada
Canada, Manitoba
Pan Am Clinic
Winnipeg, Manitoba, Canada
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic
London, Ontario, Canada
Sponsors and Collaborators
Histogenics Corporation
Investigators
Study Director: Tiffany Sepp Histogenics Corporation