Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration (CAIS)
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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
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Sponsor:
DePuy Mitek
Information provided by (Responsible Party):
DePuy Mitek
Tracking Information | |||||
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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 |
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 |
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 |
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 |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Actual Enrollment ICMJE |
75 | ||||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE |
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Responsible Party | DePuy Mitek | ||||
Study Sponsor ICMJE | DePuy Mitek | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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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 |