Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
NCT ID: NCT00881023
Last Updated: 2016-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
75 participants
INTERVENTIONAL
2010-07-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Randomized to Microfracture
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
2
Randomized to 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
3
Non-randomized with lesion greater than 6cmˆ2
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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DePuy Mitek
INDUSTRY
Responsible Party
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Principal Investigators
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Brooks Story, PhD
Role: STUDY_DIRECTOR
DePuy Synthes Mitek Sports Medicine
Locations
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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
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
OrthoIndy
Indianapolis, Indiana, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
Harvard Vanguard / New England Baptist Hospital
Chestnut Hill, Massachusetts, United States
UMass Medical Center - Orthopedic Research
Worcester, Massachusetts, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
Rothman Institute
Egg Harbor, New Jersey, United States
University Orthopaedic Group LLC
New Brunswick, New Jersey, United States
New York University School of Medicine
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Orlin & Cohen Orthopedic Group
Rockville Centre, New York, United States
Ohio State University
Columbus, Ohio, United States
Orthopaedic Research Foundation of the Carolinas
Greenville, South Carolina, United States
OrthoMemphis, PC
Memphis, Tennessee, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States
Richmond Bone & Joint Clinic, P.A.
Sugar Land, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Royal Columbian Hospital
New West Minster, British Columbia, Canada
Fowler Kennedy Sports Medicine Clinic
New West Minister, Ontario, Canada
Countries
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Other Identifiers
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IDE # 11803
Identifier Type: OTHER
Identifier Source: secondary_id
08-CAIS-05
Identifier Type: -
Identifier Source: org_study_id
NCT00595803
Identifier Type: -
Identifier Source: nct_alias
NCT01508442
Identifier Type: -
Identifier Source: nct_alias
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