Status:
UNKNOWN
Knee Articular Cartilage Repair: Cartilage Autograft Implantation System Versus Conventional Microfracture
Lead Sponsor:
Singapore General Hospital
Conditions:
Other Articular Cartilage Disorders
Osteochondritis Dissecans
Eligibility:
All Genders
21-50 years
Phase:
PHASE3
Brief Summary
The Cartilage Autograft Implantation System (CAIS) is a single-stage procedure in which cartilage is harvested from non-critical regions of articular cartilage, but then immediately morcellated and lo...
Detailed Description
Articular cartilage has limited potential for regeneration, and full-thickness cartilage defects in the knee are frequently symptomatic and debilitating. If left untreated, such injuries may progress ...
Eligibility Criteria
Inclusion
- Full-thickness articular cartilage defect on the femoral condyle or trochlea greater than 2 cm2 but less than 10 cm2 in total surface area, following debridement to healthy, stable tissue.
- Knee mechanical axis malalignment of not more than 3 degrees either varus or valgus from neutral.
- Patient is fit for surgery.
Exclusion
- Multifocal disease
- Tibial plateau lesions
- Patella lesions
- Absent menisci or meniscal tears that are unstable and cannot be successfully debrided
- Non-intact cruciate and collateral ligaments
- Inflammatory or crystalline arthropathy
- Systemic medication or conditions likely to compromise chondrocyte cell proliferation and differentiation, e.g. Cushing's syndrome, chemotherapy
- Morbid obesity (more than 150% ideal body weight)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01498029
Start Date
January 1 2012
End Date
December 1 2014
Last Update
March 21 2012
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608