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

This study has been terminated.

(Study was terminated because of very low enrollment rate.)

Sponsor:

ClinicalTrials.gov Identifier:

NCT00881023

First Posted: April 14, 2009

Last Update Posted: August 3, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

DePuy Mitek

Tracking Information

First Submitted Date ^ICMJE

April 10, 2009

First Posted Date ^ICMJE

April 14, 2009

Last Update Posted Date

August 3, 2016

Start Date ^ICMJE

July 2010

Primary Completion Date

December 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

To determine the safety and efficacy of CAIS compared to microfracture at 12 months post-treatment, with the primary efficacy assessment based on an analysis of non-inferiority of CAIS to microfracture for reduction in knee pain [ Time Frame: 12 Months ]

Change History

Complete list of historical versions of study NCT00881023 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Defect of Articular Cartilage
Osteochondritis Dissecans

Intervention ^ICMJE

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

Study Arms

Active Comparator: 1
Randomized to Microfracture

Intervention: Procedure: Microfracture
Experimental: 2
Randomized to Device

Intervention: Device: Cartilage Autograft Implantation System
Experimental: 3
Non-randomized with lesion greater than 6cmˆ2

Intervention: Device: Cartilage Autograft Implantation System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2014

Primary Completion Date

December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 55 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Canada, United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00881023

Other Study ID Numbers ^ICMJE

08-CAIS-05
IDE # 11803 ( Other Identifier: FDA )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:	No
Plan Description:	These data will not be used in support of an FDA submission, and the product will not be commercialized. As such, there is no plan to share the IPD.

Responsible Party

DePuy Mitek

Study Sponsor ^ICMJE

DePuy Mitek

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Brooks Story, PhD

DePuy Synthes Mitek Sports Medicine

PRS Account

DePuy Mitek

Verification Date

August 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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