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

Primary Purpose

Defect of Articular Cartilage, Osteochondritis Dissecans

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Microfracture
Cartilage Autograft Implantation System
Sponsored by
DePuy Mitek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Defect of Articular Cartilage

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tucson Orthopaedic Institute
  • MWMC Bentonville Hospital
  • CORE Orthopaedic Medical Center
  • Santa Monica Orthopaedic Group
  • Southern California Orthopaedic Group
  • JDP Medical Research, LLC
  • Shrock Orthopedic Research
  • Andrews Institute
  • Florida Orthopaedics Institute and Research Foundation
  • Rush University Medical Center
  • OrthoIndy
  • University of Kentucky Medical Center
  • Harvard Vanguard / New England Baptist Hospital
  • UMass Medical Center - Orthopedic Research
  • TRIA Orthopaedic Center
  • University of Missouri
  • Rothman Institute
  • University Orthopaedic Group LLC
  • New York University School of Medicine
  • University of Rochester Medical Center
  • Orlin & Cohen Orthopedic Group
  • Ohio State University
  • Orthopaedic Research Foundation of the Carolinas
  • OrthoMemphis, PC
  • Basin Orthopedic Surgical Specialists
  • Richmond Bone & Joint Clinic, P.A.
  • University of Virginia
  • Royal Columbian Hospital
  • Fowler Kennedy Sports Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Randomized to Microfracture

Randomized to Device

Non-randomized with lesion greater than 6cmˆ2

Outcomes

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

Secondary Outcome Measures

To determine the safety of CAIS through 48 months

Full Information

First Posted
April 10, 2009
Last Updated
August 1, 2016
Sponsor
DePuy Mitek
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1. Study Identification

Unique Protocol Identification Number
NCT00881023
Brief Title
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
Acronym
CAIS
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 Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated because of very low enrollment rate.
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DePuy Mitek

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Defect of Articular Cartilage, Osteochondritis Dissecans

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Randomized to Microfracture
Arm Title
2
Arm Type
Experimental
Arm Description
Randomized to Device
Arm Title
3
Arm Type
Experimental
Arm Description
Non-randomized with lesion greater than 6cmˆ2
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Cartilage Autograft Implantation System
Intervention Description
A surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the safety of CAIS through 48 months
Time Frame
48 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brooks Story, PhD
Organizational Affiliation
DePuy Synthes Mitek Sports Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Tucson Orthopaedic Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
MWMC Bentonville Hospital
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
CORE Orthopaedic Medical Center
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Santa Monica Orthopaedic Group
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Southern California Orthopaedic Group
City
Van Nuys
State/Province
California
ZIP/Postal Code
91405
Country
United States
Facility Name
JDP Medical Research, LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80014
Country
United States
Facility Name
Shrock Orthopedic Research
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Andrews Institute
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Florida Orthopaedics Institute and Research Foundation
City
Tampa
State/Province
Florida
ZIP/Postal Code
33637
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
OrthoIndy
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Harvard Vanguard / New England Baptist Hospital
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Facility Name
UMass Medical Center - Orthopedic Research
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
TRIA Orthopaedic Center
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65211
Country
United States
Facility Name
Rothman Institute
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
University Orthopaedic Group LLC
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Orlin & Cohen Orthopedic Group
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Orthopaedic Research Foundation of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
OrthoMemphis, PC
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Basin Orthopedic Surgical Specialists
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
Richmond Bone & Joint Clinic, P.A.
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Royal Columbian Hospital
City
New West Minster
State/Province
British Columbia
ZIP/Postal Code
V3L 5P5
Country
Canada
Facility Name
Fowler Kennedy Sports Medicine Clinic
City
New West Minister
State/Province
Ontario
ZIP/Postal Code
N6A 3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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