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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00881023
Recruitment Status : Terminated (Study was terminated because of very low enrollment rate.)
First Posted : April 14, 2009
Last Update Posted : August 3, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy Mitek

Tracking Information
First Submitted Date  ICMJE April 10, 2009
First Posted Date  ICMJE April 14, 2009
Last Update Posted Date August 3, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2009)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2009)
To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Defect of Articular Cartilage
  • Osteochondritis Dissecans
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 14, 2014)
75
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2009)
300
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00881023
Other Study ID Numbers  ICMJE 08-CAIS-05
IDE # 11803 ( Other Identifier: FDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
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.
Responsible Party DePuy Mitek
Study Sponsor  ICMJE DePuy Mitek
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Brooks Story, PhD DePuy Synthes Mitek Sports Medicine
PRS Account DePuy Mitek
Verification Date August 2016

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