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

Osteochondritis Dissecans Clinical Trial

— CAIS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00881023
• Other study ID #: 08-CAIS-05
• Secondary ID: IDE # 11803
• Status: Terminated
• Phase: N/A
• First received: April 10, 2009
• Last updated: August 1, 2016
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: DePuy Mitek
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00595803
• NCT01508442

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cartilage Diseases
• Defect of Articular Cartilage
• Osteochondritis
• 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

Locations

Country	Name	City	State
Canada	Fowler Kennedy Sports Medicine Clinic	New West Minister	Ontario
Canada	Royal Columbian Hospital	New West Minster	British Columbia
United States	MWMC Bentonville Hospital	Bentonville	Arkansas
United States	TRIA Orthopaedic Center	Bloomington	Minnesota
United States	University of Virginia	Charlottesville	Virginia
United States	Harvard Vanguard / New England Baptist Hospital	Chestnut Hill	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Missouri	Columbia	Missouri
United States	Ohio State University	Columbus	Ohio
United States	JDP Medical Research, LLC	Denver	Colorado
United States	Rothman Institute	Egg Harbor Township	New Jersey
United States	CORE Orthopaedic Medical Center	Encinitas	California
United States	Shrock Orthopedic Research	Ft. Lauderdale	Florida
United States	Orthopaedic Research Foundation of the Carolinas	Greenville	South Carolina
United States	Andrews Institute	Gulf Breeze	Florida
United States	OrthoIndy	Indianapolis	Indiana
United States	University of Kentucky Medical Center	Lexington	Kentucky
United States	OrthoMemphis, PC	Memphis	Tennessee
United States	University Orthopaedic Group LLC	New Brunswick	New Jersey
United States	New York University School of Medicine	New York	New York
United States	Basin Orthopedic Surgical Specialists	Odessa	Texas
United States	University of Rochester Medical Center	Rochester	New York
United States	Orlin & Cohen Orthopedic Group	Rockville Center	New York
United States	Santa Monica Orthopaedic Group	Santa Monica	California
United States	Richmond Bone & Joint Clinic, P.A.	Sugar Land	Texas
United States	Florida Orthopaedics Institute and Research Foundation	Tampa	Florida
United States	Tucson Orthopaedic Institute	Tucson	Arizona
United States	Southern California Orthopaedic Group	Van Nuys	California
United States	UMass Medical Center - Orthopedic Research	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
DePuy Mitek

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		24 Months	Yes
Secondary	To determine the safety of CAIS through 48 months		48 Months	Yes