Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- Conditions
- Degenerative Lesion of Articular Cartilage of Knee
- Interventions
- Procedure: ADSC ApplicationProcedure: Microfracture
- Registration Number
- NCT02090140
- Lead Sponsor
- University of Colorado, Denver
- Brief 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.
- Detailed Description
Patients enrolled in the ADSC cohort will undergo the following procedures: arthroscopic resection of approximately 5cc of the infrapatellar fat pad using a motorized shaver (standard use in arthroscopy). Fat will be collected in a sterile Aquavage Collection System (AV1200, MD Resources, Livermore, CA) and kept sealed until processing. Fat will then immediately be processed in the Harvest Adiprep System to separate a population of ADSCs. This system concentrates an average of 5 x 105 cells/ml. All specimens will be processed using routine sterile procedures within the operating room; cells destined for implantation will not leave the operating room. Concurrently, patients will undergo arthroscopy and similar preparation of the chondral defect and removal of the calcified cartilage layer. However, no puncture of the subchondral bone will be performed. A layer of fibrin glue (Tisseel) will be placed at the base of the defect to seal off any bleeding from the subchondral plate followed by the application of the acellular dermal matrix (Allopatch HD, MTF Corporation, Edison, NJ, USA)and ADSCs. An additional layer of Tisseel will then be applied over the cells and matrix. No additional fixation will be applied. The matrix and cells will be recessed below the articular surface by an average of 1mm.
They will then complete outcome questionnaires and additional MRI scans at 6, 12, and 24 months post-operatively.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 17
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ADSC Application ADSC Application Patients undergo an arthroscopic surgical procedure, ADSC application, followed by physical therapy. Microfracture Arm Microfracture Patients undergo an arthroscopic surgical procedure, microfracture, followed by physical therapy.
- Primary Outcome Measures
Name Time Method Health Scores on the KOOS Questionnaire Completed at baseline, 6 months, 12 months, and 24 months post-operatively. The Knee Osteoarthritis Outcome Score (KOOS), a standard outcome questionnaire for the assessment of health-related quality of life, will be completed.
- Secondary Outcome Measures
Name Time Method Functionality Scores on the Lysholm Scale Completed at baseline, 6 months, 12 months, and 24 months post-operatively. The Lysholm Scale, a standard outcome questionnaire for assessment of knee functionality, will be completed.
Cartilage Composition Assessment by MRI Scan Assessed at baseline, 6 months, 12 months, and 24 months post-operatively. Magnetic resonance imaging scans consisting of routine clinical sequences and T2 and T1p quantitative maps will be conducted. T1p and T2 mapping will be used to assess regenerative cartilage composition compared to surrounding normal cartilage, surface integrity, average cartilage thickness, and the percentage to which the defect is filled.
Pain Scores on the Visual Analog Scale (VAS) Completed at baseline, 6 months, 12 months, and 24 months post-operatively. The Visual Analog Scale, a standard outcome questionnaire for assessment of pain levels, will be completed.
Activity Level on the Tegner Activity Scale Completed at baseline, 6 months, 12 months, and 24 months post-operatively. The Tegner Activity scale, a standard outcome questionnaire for assessment of activity levels, will be completed.
Health Scores on Veterans-Rand (VR-12) Survey Completed at baseline, 6 months, 12 months, and 24 months post-operatively. The Veterans-Rand survey, a standard outcome questionnaire for assessment of health and quality of life, will be completed.
Trial Locations
- Locations (3)
Stanford Medical Outpatient Center
🇺🇸Redwood City, California, United States
UC Health Steadman Hawkins Clinic - Denver Inverness
🇺🇸Denver, Colorado, United States
Kerlan Jobe Orthopedic Institute
🇺🇸Santa Monica, California, United States