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

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	Complete list of historical versions of study NCT00881023 on ClinicalTrials.gov Archive Site
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 Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	18 Years to 55 Years (Adult)
Accepts Healthy Volunteers	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	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