Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration - Full Text View

Purpose

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.

Condition	Intervention
Defect of Articular Cartilage Osteochondritis Dissecans	Procedure: Microfracture Device: Cartilage Autograft Implantation System

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Pivotal Study to Evaluate the Safety and Efficacy of the Cartilage Autograft Implantation System (CAIS) for the Surgical Treatment of Articular Cartilage Lesions of the Knee

Resource links provided by NLM:

Genetics Home Reference related topics: familial osteochondritis dissecans

U.S. FDA Resources

Further study details as provided by DePuy Mitek:

Primary Outcome Measures:

To determine the safety and efficacy of CAIS compared to microfracture at 24 months post-treatment, with the primary efficacy assessment based on an analysis of superiority of CAIS to microfracture for reduction in knee pain and improvement in function [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	364
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	March 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Randomized to Microfracture	Procedure: Microfracture The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue Other Names: Knee Cartilage Cartilage Repair
Experimental: 2 Randomized to Device	Device: Cartilage Autograft Implantation System A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region Other Names: Knee Cartilage Cartilage Repair
Experimental: 3 Non-randomized with lesion greater than 6cmˆ2	Device: Cartilage Autograft Implantation System A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region Other Names: Knee Cartilage Cartilage Repair

Detailed Description:

The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881023

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Locations

United States, Arizona
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
United States, Arkansas
MWMC Bentonville Hospital
Bentonville, Arkansas, United States, 72712
United States, California
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
Santa Monica Orthopaedic Group
Santa Monica, California, United States, 90404
Southern California Orthopaedic Group
Van Nuys, California, United States, 91405
United States, Colorado
JDP Medical Research, LLC
Denver, Colorado, United States, 80014
United States, Florida
Shrock Orthopedic Research
Ft. Lauderdale, Florida, United States, 33316
Andrews Institute
Gulf Breeze, Florida, United States, 32561
Florida Orthopaedics Institute and Research Foundation
Tampa, Florida, United States, 33637
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
OrthoIndy
Indianapolis, Indiana, United States, 46237
United States, Kentucky
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536-0284
United States, Massachusetts
Harvard Vanguard / New England Baptist Hospital
Chestnut Hill, Massachusetts, United States, 02467
UMass Medical Center - Orthopedic Research
Worcester, Massachusetts, United States, 01655
United States, Minnesota
TRIA Orthopaedic Center
Bloomington, Minnesota, United States, 55431
United States, Missouri
University of Missouri
Columbia, Missouri, United States, 65211
United States, New Jersey
Rothman Institute
Egg Harbor Township, New Jersey, United States, 08234
University Orthopaedic Group LLC
New Brunswick, New Jersey, United States, 08901
United States, New York
New York University School of Medicine
New York, New York, United States, 10003
University of Rochester Medical Center
Rochester, New York, United States, 14618
Orlin & Cohen Orthopedic Group
Rockville Center, New York, United States, 11570
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, South Carolina
Orthopaedic Research Foundation of the Carolinas
Greenville, South Carolina, United States, 29615
United States, Tennessee
OrthoMemphis, PC
Memphis, Tennessee, United States, 38120
United States, Texas
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States, 79761
Richmond Bone & Joint Clinic, P.A.
Sugar Land, Texas, United States, 77478
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, British Columbia
Royal Columbian Hospital
New West Minster, British Columbia, Canada, V3L 5P5
Canada, Ontario
Fowler Kennedy Sports Medicine Clinic
New West Minister, Ontario, Canada, N6A 3K7

Sponsors and Collaborators

DePuy Mitek

Investigators

Study Director:

Suresh Aravind, MD

DePuy Mitek

More Information

No publications provided

Responsible Party:	DePuy Mitek
ClinicalTrials.gov Identifier:	NCT00881023 History of Changes
Obsolete Identifiers:	NCT00595803, NCT01508442
Other Study ID Numbers:	08-CAIS-05, IDE # 11803
Study First Received:	April 10, 2009
Last Updated:	October 15, 2012
Health Authority:	United States: Food and Drug Administration Canada: Health Canada

Additional relevant MeSH terms:

Osteochondritis
Osteochondritis Dissecans
Bone Diseases

Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 16, 2013