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

Not Applicable

Terminated

• Conditions: Defect of Articular Cartilage; Osteochondritis Dissecans

• Registration Number: NCT00881023
• Lead Sponsor: DePuy Mitek

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 Timeline

• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-13
• Study First Posted: 2009-04-14
• Study Start: 2010-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Disposition First Submitted: 2016-02-25
• Disposition First Submitted QC: 2016-03-24
• Disposition First Posted: 2016-04-25
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
To determine the safety of CAIS through 48 months	48 Months

Trial Locations

Locations (29)

Tucson Orthopaedic Institute; 🇺🇸 Tucson, Arizona, United States

MWMC Bentonville Hospital; 🇺🇸 Bentonville, Arkansas, United States

CORE Orthopaedic Medical Center; 🇺🇸 Encinitas, California, United States

Santa Monica Orthopaedic Group; 🇺🇸 Santa Monica, California, United States

Southern California Orthopaedic Group; 🇺🇸 Van Nuys, California, United States

JDP Medical Research, LLC; 🇺🇸 Denver, Colorado, United States

Shrock Orthopedic Research; 🇺🇸 Ft. Lauderdale, Florida, United States

Andrews Institute; 🇺🇸 Gulf Breeze, Florida, United States

Florida Orthopaedics Institute and Research Foundation; 🇺🇸 Tampa, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

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