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

DePuy Mitek75 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Defect of Articular Cartilage Osteochondritis Dissecans

Interventions

MicrofracturePROCEDURE

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

Cartilage Autograft Implantation SystemDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (29)

Outcomes

Primary Outcomes

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

Secondary Outcomes

To determine the safety of CAIS through 48 months

Time frame: 48 Months

Data from ClinicalTrials.gov

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Santa Monica Orthopaedic Group

Santa Monica, California, United States

Southern California Orthopaedic Group

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JDP Medical Research, LLC

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Shrock Orthopedic Research

Fort 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

...and 19 more locations