Study Stopped
Study was terminated because of very low enrollment rate.
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
CAIS
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
2 other identifiers
interventional
75
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2009
CompletedFirst Posted
Study publicly available on registry
April 14, 2009
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 3, 2016
August 1, 2016
4.4 years
April 10, 2009
August 1, 2016
Conditions
Outcome Measures
Primary Outcomes (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
24 Months
Secondary Outcomes (1)
To determine the safety of CAIS through 48 months
48 Months
Study Arms (3)
1
ACTIVE COMPARATORRandomized to Microfracture
2
EXPERIMENTALRandomized to Device
3
EXPERIMENTALNon-randomized with lesion greater than 6cmˆ2
Interventions
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
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 Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DePuy Miteklead
Study Sites (29)
Tucson Orthopaedic Institute
Tucson, Arizona, 85712, United States
MWMC Bentonville Hospital
Bentonville, Arkansas, 72712, United States
CORE Orthopaedic Medical Center
Encinitas, California, 92024, United States
Santa Monica Orthopaedic Group
Santa Monica, California, 90404, United States
Southern California Orthopaedic Group
Van Nuys, California, 91405, United States
JDP Medical Research, LLC
Denver, Colorado, 80014, United States
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316, United States
Andrews Institute
Gulf Breeze, Florida, 32561, United States
Florida Orthopaedics Institute and Research Foundation
Tampa, Florida, 33637, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
OrthoIndy
Indianapolis, Indiana, 46237, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0284, United States
Harvard Vanguard / New England Baptist Hospital
Chestnut Hill, Massachusetts, 02467, United States
UMass Medical Center - Orthopedic Research
Worcester, Massachusetts, 01655, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, 55431, United States
University of Missouri
Columbia, Missouri, 65211, United States
Rothman Institute
Egg Harbor, New Jersey, 08234, United States
University Orthopaedic Group LLC
New Brunswick, New Jersey, 08901, United States
New York University School of Medicine
New York, New York, 10003, United States
University of Rochester Medical Center
Rochester, New York, 14618, United States
Orlin & Cohen Orthopedic Group
Rockville Centre, New York, 11570, United States
Ohio State University
Columbus, Ohio, 43210, United States
Orthopaedic Research Foundation of the Carolinas
Greenville, South Carolina, 29615, United States
OrthoMemphis, PC
Memphis, Tennessee, 38120, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761, United States
Richmond Bone & Joint Clinic, P.A.
Sugar Land, Texas, 77478, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Royal Columbian Hospital
New West Minster, British Columbia, V3L 5P5, Canada
Fowler Kennedy Sports Medicine Clinic
New West Minister, Ontario, N6A 3K7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Brooks Story, PhD
DePuy Synthes Mitek Sports Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 10, 2009
First Posted
April 14, 2009
Study Start
July 1, 2010
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
August 3, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share
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.