Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration

Stopped early · Not applicable

Conditions studied: Defect of Articular Cartilage, Osteochondritis Dissecans

In brief

The Cartilage Autograft Implantation System (CAIS) is designed as a single surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region. CAIS is indicated for the repair of articular cartilage lesions and osteochondritis dissecans (OCD) of the knee through cartilage regeneration.

Key facts

Study ID

NCT00881023

Run by

DePuy Mitek

People needed

75

Starts

2010-07-01

Expected to finish

2014-12-01

Last updated by the study team

2016-08-03

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A male or female 18 to 55 years of age,
• Has 1 or 2 focal chondral lesions, that require repair, per index knee presenting with moderate to severe knee pain. Each lesion is ≤6 mm in depth and has an area of ≥1 cm2 and ≤10 cm2. Arthroscopic confirmation indicates that the lesions are either a non-OCD lesion between grades I and III (D) or an OCD lesion between grades I and IV(A)
• Prior failed chondral treatment is allowed if the procedure occurred > 6 months for debridement and lavage or > 1 year for marrow stimulation techniques.

You may not qualify if…

• Have more than 2 chondral lesions on the index knee,
• Bipolar lesions on the index knee,
• Greater than 5 degrees of malalignment,
• Require bilateral surgery
• Have a diagnosis of clinical and/or radiographic disease of the index joint.

Where it is running

• Tucson Orthopaedic Institute — Tucson, Arizona, United States
• MWMC Bentonville Hospital — Bentonville, Arkansas, United States
• CORE Orthopaedic Medical Center — Encinitas, California, United States
• Santa Monica Orthopaedic Group — Santa Monica, California, United States
• Southern California Orthopaedic Group — Van Nuys, California, United States
• JDP Medical Research, LLC — Denver, Colorado, United States
• Shrock Orthopedic Research — Fort Lauderdale, Florida, United States
• Andrews Institute — Gulf Breeze, Florida, United States
• Florida Orthopaedics Institute and Research Foundation — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• OrthoIndy — Indianapolis, Indiana, United States
• University of Kentucky Medical Center — Lexington, Kentucky, United States
• Harvard Vanguard / New England Baptist Hospital — Chestnut Hill, Massachusetts, United States
• UMass Medical Center - Orthopedic Research — Worcester, Massachusetts, United States
• TRIA Orthopaedic Center — Bloomington, Minnesota, United States
• University of Missouri — Columbia, Missouri, United States
• Rothman Institute — Egg Harbor, New Jersey, United States
• University Orthopaedic Group LLC — New Brunswick, New Jersey, United States
• New York University School of Medicine — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Orlin & Cohen Orthopedic Group — Rockville Centre, New York, United States
• Ohio State University — Columbus, Ohio, United States
• Orthopaedic Research Foundation of the Carolinas — Greenville, South Carolina, United States
• OrthoMemphis, PC — Memphis, Tennessee, United States
• Basin Orthopedic Surgical Specialists — Odessa, Texas, United States

Full record on ClinicalTrials.gov

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