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Trial record 3 of 5 for:    cartilage implant | Canada, Ontario

Confirmatory Study of NeoCart in Knee Cartilage Repair

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Histogenics Corporation
Sponsor:
Information provided by (Responsible Party):
Histogenics Corporation
ClinicalTrials.gov Identifier:
NCT01066702
First received: February 8, 2010
Last updated: February 7, 2017
Last verified: February 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 ]

Estimated 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

Contacts
Contact: Tiffany Sepp 1-855-552-KNEE NeoCartContact@Histogenics.com
Contact: NeoCart Website: NeoCartImplant.com

  Hide Study Locations
Locations
United States, Arizona
Mezona Orthopaedics Recruiting
Gilbert, Arizona, United States
Principal Investigator: Kipling Sharpe, MD         
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Jelena Candito    520-784-6446    jcandito@tucsonortho.com   
Principal Investigator: Nebojsa Skrepnik, MD         
United States, California
Grossmont Orthopedic Medical Group Recruiting
La Mesa, California, United States, 91942
Contact: Mona Hacker, MD    619-820-8779    monahacker@cox.net   
Principal Investigator: Scott Hacker, MD         
Orthopaedic Specialty Institute/Newport Orthopedic Institute (OSI/NOI) Recruiting
Orange, California, United States, 92868
Contact: Camille Borges       cborges@osiortho.com   
Principal Investigator: Benjamin Rubin, MD         
UCSF Mission Bay Orthopaedic Institute Recruiting
San Francisco, California, United States, 94158
Contact: KR Borak    415-353-7987    Kristina.Borak@ucsf.edu   
Principal Investigator: C. Benjamin Ma, MD         
Advanced Orthopedic Surgery Center Recruiting
Temecula, California, United States
Principal Investigator: Scott Herron, MD         
Southern California Orthopedic Research and Education Recruiting
Van Nuys, California, United States, 91405
Contact: Rosa Bautista         
Principal Investigator: Mark Getelman, MD         
United States, Colorado
Colorado University Boulder Recruiting
Boulder, Colorado, United States, 80304
Contact: Matthew Kraetler       matthew.kraeutler@ucdenver.edu   
Principal Investigator: Eric McCarty, MD         
JDP Medical Research Withdrawn
Denver, Colorado, United States, 80230
United States, Connecticut
University of Connecticut Health Center Withdrawn
Farmington, Connecticut, United States, 06030
United States, Florida
Florida Research Associates Withdrawn
DeLand, Florida, United States, 32720
Shrock Clinical Research Recruiting
Fort Lauderdale, Florida, United States, 33316
Contact: Natalie Shrock, ARNP, CRC    954-626-3743    Natalie@shrockresearch.com   
Principal Investigator: Kevin B Shrock, MD         
Sunrise Medical Research Withdrawn
Lauderdale Lakes, Florida, United States, 33319
Jewett Orthopaedic Clinic Recruiting
Orlando, Florida, United States, 32822
Contact: Derrica Robinson    407-731-5625    drobinson@cornerstonestudy.com   
Principal Investigator: Sean McFadden, D.O.         
Advent Clinical Research Centers Withdrawn
Pinellas Park, Florida, United States, 33781
United States, Georgia
Optim Healthcare Recruiting
Savannah, Georgia, United States, 31405
Contact: Kelly Wiggins, RN, CCRC    912-651-8829    kwiggins@optimhealth.com   
Principal Investigator: David Palmer, MD         
United States, Idaho
St. Lukes Medical Center Recruiting
Boise, Idaho, United States, 83702
Contact: Kelli Bruni    208-489-4369    brunik@slhs.org   
Principal Investigator: Kevin Shea, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Principal Investigator: Brian J. Cole, MD         
United States, Indiana
OrthoIndy Recruiting
Greenwood, Indiana, United States, 46143
Contact: Vicki R Snodgrass-Miller    317-884-5230    vsmiller@orthoindy.com   
Principal Investigator: Jack Farr II, MD         
United States, Louisiana
Ochsner Clinic Sports Medicine Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Laura Martinez    504-842-0263    laura.martinez@ochsner.org   
Principal Investigator: Deryk Jones, MD         
United States, Maine
Orthopaedic Associates Recruiting
Portland, Maine, United States, 04102
Contact: Bernadette Shaw, PA    207-828-2176    bshaw@orthoassociates.com   
Principal Investigator: Thomas Murray Jr, MD         
United States, Maryland
Union Memorial Hospital Withdrawn
Baltimore, Maryland, United States, 21218
United States, Massachusetts
Brigham and Women's Hospital Withdrawn
Chestnut Hill, Massachusetts, United States, 02467
Harvard Vanguard Medical Associates Recruiting
West Roxbury, Massachusetts, United States, 02467
Contact: Stacey Brown    617-421-5067    Stacey_Brown@atriushealth.org   
Contact: Emily Degan         
Principal Investigator: Kai Mithoefer, MD         
United States, Michigan
William Beaumont Hospital Recruiting
Royal Oaks, Michigan, United States, 48073
Contact: Blerina Pople    248-551-3533    Blerina.pople@beaumont.edu   
Principal Investigator: Joseph Guettler, MD         
United States, Minnesota
TRIA Orthopaedic Center Recruiting
Bloomington, Minnesota, United States, 55431
Contact    952-806-5603    institute@tria.com   
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jennifer Krogman    507-538-3562    krogman.jennifer@mayo.edu   
Principal Investigator: Aaron J Krych, MD         
United States, Missouri
Washington University at St. Louis Withdrawn
Chesterfield, Missouri, United States, 63017
United States, Montana
Alpine Orthopedics & Sports Medicine Recruiting
Bozeman, Montana, United States, 59718
Contact: Rachel Stertz    406-459-6741    rstertzresearch@gmail.com   
Principal Investigator: Timothy O'Brien, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Pascal Stirnimann    505-272-6057    pstirnimann@salud.unm.edu   
Principal Investigator: Gehron Treme, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Gregory Mahoney    212-774-2449    mahonyg@hss.edu   
Principal Investigator: Riley Williams, III, MD         
Keller Army Community Hospital Withdrawn
West Point, New York, United States, 10996
United States, North Carolina
OrthoCarolina Withdrawn
Charlotte, North Carolina, United States, 28207
Duke Sports Medicine Recruiting
Durham, North Carolina, United States, 27710
Contact: Suzanne Finley, EMTP    919-684-5431    suzanne.finley@duke.edu   
Contact: Libby Pennington    919-684-6071    penni009@mc.duke.edu   
Principal Investigator: Dean Taylor, MD         
United States, Ohio
Cleveland Clinic Withdrawn
Cleveland, Ohio, United States, 44195
Ohio State University - Department of Sports Medicine Recruiting
Columbus, Ohio, United States, 43221
Contact: Courtney Webb       Courtney.Webb@osumc.edu   
Principal Investigator: David Flanigan, MD         
University of Toledo Medical Center Withdrawn
Toledo, Ohio, United States, 43614
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Katlyn Campbell    503-418-8678    campkatl@ohsu.edu   
Principal Investigator: Dennis Crawford, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Evan Bannister       Evan.Bannister@uphs.upenn.edu   
Principal Investigator: Brian Sennett, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States
Contact: Anne Voisinet         
Principal Investigator: Brett Owens, MD         
United States, Texas
The San Antonio Orthopaedic Group (TSAOG) Recruiting
San Antonio, Texas, United States, 78216
Contact: Maria Lopez    210-804-5901    mlopez@tsaog.com   
Principal Investigator: Brad Tolin, MD         
United States, Utah
The Orthopedic Specialty Hospital Recruiting
Murray, Utah, United States, 84107
Contact: Vanessa Henriksen    801-314-4020    vanessa.henriksen@imail.org   
Principal Investigator: Tyler Barker, MD         
United States, Virginia
Jordan Young Institute Withdrawn
Virginia Beach, Virginia, United States, 23462
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Deborah Fly         
Contact: Albert Gee, MD         
Canada, British Columbia
Simon Fraser Orthopaedic Fund Recruiting
New Westminster, British Columbia, Canada
Canada, Manitoba
Pan Am Clinic Recruiting
Winnipeg, Manitoba, Canada
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic Recruiting
London, Ontario, Canada
Sponsors and Collaborators
Histogenics Corporation
Investigators
Study Director: Tiffany Sepp Histogenics Corporation