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

August 1, 2016 updated by: DePuy Mitek

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the safety of CAIS through 48 months
Time Frame: 48 Months
48 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DePuy Mitek

Investigators

  • Study Director: Brooks Story, PhD, DePuy Synthes Mitek Sports Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 10, 2009

First Submitted That Met QC Criteria

April 13, 2009

First Posted (Estimate)

April 14, 2009

Study Record Updates

Last Update Posted (Estimate)

August 3, 2016

Last Update Submitted That Met QC Criteria

August 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-CAIS-05
  • IDE # 11803 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD 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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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