Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.
Primary outcome(s):
Adverse Events (According to Common Terminology of Criteria for Adverse Events (CTCAE) version 3). Measurement time: baseline, 3, 30, 60, 180 and 360 days.
Therapeutic efficacy (improvement in quality of life index. Interrogation on joint pain intensity and quality of life; WOMAC, RAPID3 and RASMUSSEN Clinical score). Measurement time: baseline, at 3, 30, 60, 180 and 360 days.
Key secondary outcomes:
Full joint improvement: Thickness of articular cartilage by (Magnetic Resonance Imaging analysis of treated joint to assess variations in thickness of articular cartilage). Measurement time: baseline and 12 months.