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

• ClinicalTrials.gov Identifier: NCT00881023
• Recruitment Status: Terminated
• First Posted: April 14, 2009
• Last Update Posted: August 3, 2016
• Sponsor: DePuy Mitek
• Information provided by (Responsible Party): DePuy Mitek

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Defect of Articular Cartilage; Osteochondritis Dissecans	Procedure: Microfracture; Device: Cartilage Autograft Implantation System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: July 2010
• Actual Primary Completion Date: December 2014
• Actual Study Completion Date: December 2014

Arms and Interventions

Arm	Intervention/treatment
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
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
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• 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

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: Brooks Story, PhD; DePuy Synthes Mitek Sports Medicine

More Information

• Responsible Party: DePuy Mitek
• ClinicalTrials.gov Identifier: NCT00881023
• Obsolete Identifiers: NCT00595803, NCT01508442
• Other Study ID Numbers: 08-CAIS-05; IDE # 11803 ( Other Identifier: FDA )
• First Posted: April 14, 2009
• Last Update Posted: August 3, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.

Additional relevant MeSH terms:

Osteochondritis; Osteochondritis Dissecans; Bone Diseases; Musculoskeletal Diseases; Cartilage Diseases; Connective Tissue Diseases