Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
Randomized Controlled Trial of Microfracture Versus Adipose Derived Stem Cells for the Treatment of Isolated Articular Cartilage Defects
University of Colorado, Denver
17 participants
Nov 1, 2015
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to compare two biologic methods for the treatment of articular cartilage defects in the knee. The first method, microfracture, is the standard of care and is routinely used to recruit cells from the subchondral bone marrow to the site of cartilage loss. The second method is the application of adipose-derived stem cells (ADSCs) to the defect site. In theory, ADSCs on a collagen scaffold should enable the delivery of more specific progenitor cells to the site of injury, resulting in better regeneration and integration of articular cartilage at the site of a defect as compared to the microfracture method.
Eligibility
Inclusion Criteria3
- Must be between ages 18 and 50 years.
- Must have a discrete, contained chondral defect less than 400mm\^2 located on the medial or lateral femoral condyle
- Must have overall neutral lower limb mechanical alignment (\<5 degrees varus or valgus).
Exclusion Criteria4
- Ages younger than 18 years and older than 50 years.
- If they have undergone previous chondral procedures
- If they have pre-existing osteoarthritis (Kellegren-Lawrence Grade ≥2)
- If they have a BMI \>30.
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Interventions
Patients will undergo arthroscopic resection of approximately 5cc of the infrapatellar fat pad, which will be collected for processing for a population of ADSCs. Patients will undergo arthroscopy and preparation of the chondral defect and removal of the calcified cartilage layer. Tisseel Fibrin glue will be placed at the base of the defect side, followed by the application of the acellular collagen dermal matrix, ADSCs, and an additional layer of fibrin glue.
Microfracture surgery is the standard of care for articular cartilage lesions. Patients will undergo arthroscopy with standard technique of microfracture preparation, including the creation of vertical, stable defect edges and removal of the calcified cartilage layer. A microfracture awl will then be used to perform the microfracture technique (6mm below the subchondral plate).
Locations(3)
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NCT02090140