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

• ClinicalTrials.gov Identifier: NCT00881023
• Recruitment Status: Terminated
• First Posted: April 14, 2009
• Last Update Posted: August 3, 2016
• Sponsor: DePuy Mitek
• Information provided by (Responsible Party): DePuy Mitek

Tracking Information

• First Submitted Date: April 10, 2009
• First Posted Date: April 14, 2009
• Last Update Posted Date: August 3, 2016
• Study Start Date: July 2010
• Actual Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (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 ]
• Current Secondary Outcome Measures (submitted: April 13, 2009): To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Defect of Articular Cartilage
• Osteochondritis Dissecans

Intervention

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: May 14, 2014): 75
• Original Estimated Enrollment (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

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: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT00881023
• Other Study ID Numbers: 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: DePuy Mitek
• Collaborators: Not Provided

Investigators

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

• PRS Account: DePuy Mitek
• Verification Date: August 2016