Clinical trial NCT00881023: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Defect of Articular Cartilage
Osteochondritis Dissecans
Lead sponsor: DePuy Mitek
Sponsor class: INDUSTRY
First posted: 2009-04-14
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 24 Months
Secondary outcomes:
measure: To determine the safety of CAIS through 48 months
timeFrame: 48 Months
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Tucson Orthopaedic Institute
state: Arizona
city: Bentonville
country: United States
facility: MWMC Bentonville Hospital
state: Arkansas
city: Encinitas
country: United States
facility: CORE Orthopaedic Medical Center
state: California
city: Santa Monica
country: United States
facility: Santa Monica Orthopaedic Group
state: California
city: Van Nuys
country: United States
facility: Southern California Orthopaedic Group
state: California
city: Denver
country: United States
facility: JDP Medical Research, LLC
state: Colorado
city: Ft. Lauderdale
country: United States
facility: Shrock Orthopedic Research
state: Florida
city: Gulf Breeze
country: United States
facility: Andrews Institute
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedics Institute and Research Foundation
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: OrthoIndy
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Chestnut Hill
country: United States
facility: Harvard Vanguard / New England Baptist Hospital
state: Massachusetts
city: Worcester
country: United States
facility: UMass Medical Center - Orthopedic Research
state: Massachusetts
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: Egg Harbor Township
country: United States
facility: Rothman Institute
state: New Jersey
city: New Brunswick
country: United States
facility: University Orthopaedic Group LLC
state: New Jersey
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Rockville Center
country: United States
facility: Orlin & Cohen Orthopedic Group
state: New York
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Greenville
country: United States
facility: Orthopaedic Research Foundation of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: OrthoMemphis, PC
state: Tennessee
city: Odessa
country: United States
facility: Basin Orthopedic Surgical Specialists
state: Texas
city: Sugar Land
country: United States
facility: Richmond Bone & Joint Clinic, P.A.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: New West Minster
country: Canada
facility: Royal Columbian Hospital
state: British Columbia
city: New West Minister
country: Canada
facility: Fowler Kennedy Sports Medicine Clinic
state: Ontario
Study officials:
affiliation: DePuy Synthes Mitek Sports Medicine
name: Brooks Story, PhD
role: STUDY_DIRECTOR
References: