Use of Cell Therapy to Enhance Arthroscopic Knee Cartilage Surgery
Articular Cartilage Defect Grade III or IV of the Knee
Procedure: Autologous Cell
Procedure: Standard microfracture arthroscopic surgery
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Autologous Cell Therapy Enhancement of Microfracture Surgery|
- Magnetic Resonance Imaging (MRI) for osteochondral defect filling [ Time Frame: 12 months ] [ Designated as safety issue: No ]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.
- Pain Scores on Numerical Rating Scale [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Knee Injury and Osteoarthritis Outcomes Survey (KOOS) [ Time Frame: 12 months postop ] [ Designated as safety issue: No ]Survey
- Knee Range of Motion [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
- Number of Patients with Adverse Events as a Measure of Safety [ Time Frame: up to 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||August 2017|
|Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Experimental: Autologous Cell
Regenerative cells obtained from autologous fat are administered in the knee at microfracture site.
|Procedure: Autologous Cell|
Sham Comparator: Control
Standard arthroscopy with sham lipoplasty procedure (no fat cells harvested).
|Procedure: Standard microfracture arthroscopic surgery|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01799876
|United States, Texas|
|Fondren Orthopedic Group, L.L.P.|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Robert L Burke, MD||Fondren Orthopedic Group L.L.P.|