Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration (CAIS)
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| ClinicalTrials.gov Identifier: NCT00881023 |
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Recruitment Status :
Terminated
(Study was terminated because of very low enrollment rate.)
First Posted : April 14, 2009
Last Update Posted : August 3, 2016
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Sponsor:
DePuy Mitek
Information provided by (Responsible Party):
DePuy Mitek
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Defect of Articular Cartilage Osteochondritis Dissecans | Procedure: Microfracture Device: Cartilage Autograft Implantation System | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 75 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 Start Date : | July 2010 |
| Actual Primary Completion Date : | December 2014 |
| Actual Study Completion Date : | December 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Familial osteochondritis dissecans
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Randomized to Microfracture
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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
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Experimental: 2
Randomized to Device
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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
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Experimental: 3
Non-randomized with lesion greater than 6cmˆ2
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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
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Primary Outcome Measures :
- 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 Outcome Measures :
- To determine the safety of CAIS through 48 months [ Time Frame: 48 Months ]
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00881023
Hide Study Locations
Locations
| United States, Arizona | |
| Tucson Orthopaedic Institute | |
| Tucson, Arizona, United States, 85712 | |
| United States, Arkansas | |
| MWMC Bentonville Hospital | |
| Bentonville, Arkansas, United States, 72712 | |
| United States, California | |
| CORE Orthopaedic Medical Center | |
| Encinitas, California, United States, 92024 | |
| Santa Monica Orthopaedic Group | |
| Santa Monica, California, United States, 90404 | |
| Southern California Orthopaedic Group | |
| Van Nuys, California, United States, 91405 | |
| United States, Colorado | |
| JDP Medical Research, LLC | |
| Denver, Colorado, United States, 80014 | |
| United States, Florida | |
| Shrock Orthopedic Research | |
| Ft. Lauderdale, Florida, United States, 33316 | |
| Andrews Institute | |
| Gulf Breeze, Florida, United States, 32561 | |
| Florida Orthopaedics Institute and Research Foundation | |
| Tampa, Florida, United States, 33637 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| OrthoIndy | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536-0284 | |
| United States, Massachusetts | |
| Harvard Vanguard / New England Baptist Hospital | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| UMass Medical Center - Orthopedic Research | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Minnesota | |
| TRIA Orthopaedic Center | |
| Bloomington, Minnesota, United States, 55431 | |
| United States, Missouri | |
| University of Missouri | |
| Columbia, Missouri, United States, 65211 | |
| United States, New Jersey | |
| Rothman Institute | |
| Egg Harbor Township, New Jersey, United States, 08234 | |
| University Orthopaedic Group LLC | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| New York University School of Medicine | |
| New York, New York, United States, 10003 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14618 | |
| Orlin & Cohen Orthopedic Group | |
| Rockville Center, New York, United States, 11570 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, South Carolina | |
| Orthopaedic Research Foundation of the Carolinas | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Tennessee | |
| OrthoMemphis, PC | |
| Memphis, Tennessee, United States, 38120 | |
| United States, Texas | |
| Basin Orthopedic Surgical Specialists | |
| Odessa, Texas, United States, 79761 | |
| Richmond Bone & Joint Clinic, P.A. | |
| Sugar Land, Texas, United States, 77478 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Canada, British Columbia | |
| Royal Columbian Hospital | |
| New West Minster, British Columbia, Canada, V3L 5P5 | |
| Canada, Ontario | |
| Fowler Kennedy Sports Medicine Clinic | |
| New West Minister, Ontario, Canada, N6A 3K7 | |
Sponsors and Collaborators
DePuy Mitek
Investigators
| Study Director: | Brooks Story, PhD | DePuy Synthes Mitek Sports Medicine |
| Responsible Party: | DePuy Mitek |
| ClinicalTrials.gov Identifier: | NCT00881023 History of Changes |
| Obsolete Identifiers: | NCT00595803, NCT01508442 |
| Other Study ID Numbers: |
08-CAIS-05 IDE # 11803 ( Other Identifier: FDA ) |
| First Posted: | April 14, 2009 Key Record Dates |
| Last Update Posted: | August 3, 2016 |
| Last Verified: | August 2016 |
| Individual Participant Data (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. |
Additional relevant MeSH terms:
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Osteochondritis Osteochondritis Dissecans Cartilage Diseases |
Bone Diseases Musculoskeletal Diseases Connective Tissue Diseases |