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

This study has been terminated.
(Study was terminated because of very low enrollment rate.)
Sponsor:
Information provided by (Responsible Party):
DePuy Mitek
ClinicalTrials.gov Identifier:
NCT00881023
First received: April 10, 2009
Last updated: August 1, 2016
Last verified: August 2016
History of Changes

April 10, 2009
August 1, 2016
July 2010
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
To determine the safety and efficacy of CAIS compared to microfracture at 12 months post-treatment, with the primary efficacy assessment based on an analysis of non-inferiority of CAIS to microfracture for reduction in knee pain [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00881023 on ClinicalTrials.gov Archive Site
To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
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.
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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Defect of Articular Cartilage
  • Osteochondritis Dissecans
  • 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
  • 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
  • Active Comparator: 1
    Randomized to Microfracture
    Intervention: Procedure: Microfracture
  • Experimental: 2
    Randomized to Device
    Intervention: Device: Cartilage Autograft Implantation System
  • Experimental: 3
    Non-randomized with lesion greater than 6cmˆ2
    Intervention: Device: Cartilage Autograft Implantation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
75
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00881023
08-CAIS-05, IDE # 11803
No
No
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.
DePuy Mitek
DePuy Mitek
Not Provided
Study Director: Brooks Story, PhD DePuy Synthes Mitek Sports Medicine
DePuy Mitek
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP