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

Not Applicable

Terminated

Conditions: Defect of Articular Cartilage
Osteochondritis Dissecans

Interventions: Procedure: Microfracture
Device: Cartilage Autograft Implantation System

Registration Number: NCT00881023

Lead Sponsor: DePuy Mitek

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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 75

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Microfracture	Randomized to Microfracture
2	Cartilage Autograft Implantation System	Randomized to Device
3	Cartilage Autograft Implantation System	Non-randomized with lesion greater than 6cmˆ2

Primary Outcome Measures

Name	Time	Method
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	24 Months

Secondary Outcome Measures

Name	Time	Method
To determine the safety of CAIS through 48 months	48 Months

Trial Locations

Locations (29): Ohio State University
🇺🇸
Columbus, Ohio, United States
Santa Monica Orthopaedic Group
🇺🇸
Santa Monica, California, United States
CORE Orthopaedic Medical Center
🇺🇸
Encinitas, California, United States
Shrock Orthopedic Research
🇺🇸
Ft. Lauderdale, Florida, United States
Southern California Orthopaedic Group
🇺🇸
Van Nuys, California, United States
Florida Orthopaedics Institute and Research Foundation
🇺🇸
Tampa, Florida, United States
University of Kentucky Medical Center
🇺🇸
Lexington, Kentucky, United States
Rush University Medical Center
🇺🇸
Chicago, Illinois, United States
Harvard Vanguard / New England Baptist Hospital
🇺🇸
Chestnut Hill, Massachusetts, United States
UMass Medical Center - Orthopedic Research
🇺🇸
Worcester, Massachusetts, United States
University of Missouri
🇺🇸
Columbia, Missouri, United States
TRIA Orthopaedic Center
🇺🇸
Bloomington, Minnesota, United States
New York University School of Medicine
🇺🇸
New York, New York, United States
Orlin & Cohen Orthopedic Group
🇺🇸
Rockville Center, New York, United States
Orthopaedic Research Foundation of the Carolinas
🇺🇸
Greenville, South Carolina, United States
Basin Orthopedic Surgical Specialists
🇺🇸
Odessa, Texas, United States
Richmond Bone & Joint Clinic, P.A.
🇺🇸
Sugar Land, Texas, United States
Fowler Kennedy Sports Medicine Clinic
🇨🇦
New West Minister, Ontario, Canada
Andrews Institute
🇺🇸
Gulf Breeze, Florida, United States
OrthoMemphis, PC
🇺🇸
Memphis, Tennessee, United States
MWMC Bentonville Hospital
🇺🇸
Bentonville, Arkansas, United States
University of Rochester Medical Center
🇺🇸
Rochester, New York, United States
University Orthopaedic Group LLC
🇺🇸
New Brunswick, New Jersey, United States
Rothman Institute
🇺🇸
Egg Harbor Township, New Jersey, United States
OrthoIndy
🇺🇸
Indianapolis, Indiana, United States
Tucson Orthopaedic Institute
🇺🇸
Tucson, Arizona, United States
JDP Medical Research, LLC
🇺🇸
Denver, Colorado, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Royal Columbian Hospital
🇨🇦
New West Minster, British Columbia, Canada