Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
- Conditions
- Articular Cartilage Defect Grade III or IV of the Knee
- Interventions
- Procedure: Standard microfracture arthroscopic surgeryProcedure: Autologous Cell
- Registration Number
- NCT01799876
- Lead Sponsor
- Fondren Orthopedic Group L.L.P.
- Brief Summary
The purpose of this study is to assess the potential benefit of enhancing knee surgery for cartilage injury using some of the patient's own cells, taken from fat tissue, that may be able to help cartilage to regenerate.
- Detailed Description
Participation in this study will allow the surgical team to remove a small amount of fat (20 to 30 ml, or between 1 and 2 tablespoons) from just below the skin in the belly region that will be processed to remove regenerative cells, which will then inserted into the knee to the damaged cartilage. These cells may encourage healing at the surgical site, although whether or how much they encourage healing is unknown. Determining whether such improved healing occurs is the purpose of this study.
Some patients will have the fat removed and cells inserted in their knee, and other patients will not have the fat removed or cells inserted. To which group patients are assigned is determined by a random process, similar to flipping a coin. The surgery is the same in all other ways for all patients.
Participation will require attending regularly scheduled postoperative visits, having 3 MRI tests, and answering a short survey. No additional visits other beyond those normally scheduled for postsurgical care are required.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Subjects undergoing microfracture surgery for the repair of articular cartilage
- Osteochondral defect Grade III or IV
- Age 18 to 68 years
- Sufficient subcutaneous adipose tissue to yield 20-30 cc of lipoaspirate
- Written informed consent
- Ability to speak, read and write English or Spanish
- Inability to speak, read and write English or Spanish
- Evidence of malignant disorder/neoplasm in past 24 months
- History of basal cell carcinoma
- History of smoking and not committed to give up
- Chronic skin conditions
- Connective, metabolic or skin disease
- Evidence of active infection
- Pregnancy or lactating for female subjects
- Diabetes Type I or II
- Current steroid use
- Immunosuppressive medication
- Renal failure (creatine > 1.8 mg/dL)
- Hepatic failure (AST, ALT >2 times normal values; bilirubin >2.0 mg/dL)
- Inflammatory joint diseases of the knee that indicate additional, conflating therapies
- Joint infection within the past 6 months
- Meniscal resection of greater than 50% prior to, or at time of procedure
- Uncorrected joint instability
- Joint malalignment > 5 degrees
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard microfracture arthroscopic surgery Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested). Autologous Cell Autologous Cell Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
- Primary Outcome Measures
Name Time Method Magnetic Resonance Imaging (MRI) for osteochondral defect filling 12 months Filling will be scored by quartile with 1 point for less than 25% filling of the defect and 4 points for greater than 75% filling. Evaluated by radiologist who is blinded to group assignment.
- Secondary Outcome Measures
Name Time Method Knee Range of Motion up to 1 year Pain Scores on Numerical Rating Scale up to 1 year Knee Injury and Osteoarthritis Outcomes Survey (KOOS) 12 months postop Survey
Number of Patients with Adverse Events as a Measure of Safety up to 1 year
Trial Locations
- Locations (1)
Fondren Orthopedic Group, L.L.P.
🇺🇸Houston, Texas, United States