Confirmatory Study of NeoCart in Knee Cartilage Repair

Stopped early · Phase 3

Conditions studied: Articular Cartilage Defects in the Knee Joint

In brief

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.

Key facts

Study ID

NCT01066702

Run by

Histogenics Corporation

People needed

245

Starts

2010-05-01

Expected to finish

2019-03-01

Last updated by the study team

2019-03-29

Who can join

Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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

Full record on ClinicalTrials.gov

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