Status:
TERMINATED
Cartilage Autograft Implantation System (CAIS) for the Repair of Knee Cartilage Through Cartilage Regeneration
Lead Sponsor:
DePuy Mitek
Conditions:
Defect of Articular Cartilage
Osteochondritis Dissecans
Eligibility:
All Genders
18-55 years
Phase:
NA
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 weig...
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 us...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00881023
Start Date
July 1 2010
End Date
December 1 2014
Last Update
August 3 2016
Active Locations (29)
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1
Tucson Orthopaedic Institute
Tucson, Arizona, United States, 85712
2
MWMC Bentonville Hospital
Bentonville, Arkansas, United States, 72712
3
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
4
Santa Monica Orthopaedic Group
Santa Monica, California, United States, 90404