Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Mitek
ClinicalTrials.gov Identifier:
NCT00881023
First received: April 10, 2009
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Defect of Articular Cartilage
Osteochondritis Dissecans
 Procedure: Microfracture
Device: Cartilage Autograft Implantation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by DePuy Mitek:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 364
Study Start Date: July 2010
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Randomized to Microfracture
 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
Other Names:
  • Knee
  • Cartilage
  • Cartilage Repair
Experimental: 2
Randomized to Device
 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
Other Names:
  • Knee
  • Cartilage
  • Cartilage Repair
Experimental: 3
Non-randomized with lesion greater than 6cmˆ2
 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
Other Names:
  • Knee
  • Cartilage
  • Cartilage Repair

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881023

  Show 29 Study Locations
Sponsors and Collaborators
DePuy Mitek
Investigators
Study Director: Suresh Aravind, MD DePuy Mitek
  More Information

No publications provided

Responsible Party: DePuy Mitek
ClinicalTrials.gov Identifier: NCT00881023     History of Changes
Obsolete Identifiers: NCT00595803, NCT01508442
Other Study ID Numbers: 08-CAIS-05, IDE # 11803
Study First Received: April 10, 2009
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Osteochondritis
Osteochondritis Dissecans
Bone Diseases
 Musculoskeletal Diseases
Cartilage Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on June 17, 2013