Outcomes
pain
The primary analyses of the data were performed according to subjects’ original treatment assignment (that is, intention-to-treat analyses) regardless of their compliance and the inclusion of all data from all subjects randomized in the final analysis. The two co-primary efficacy endpoints in this intent-to-treat, parallel-group trial were VAS and KOOS pain score at 12-month visit from baseline.KOOS is a self-reported outcome measure assessing the patient’s opinion about the health, symptoms and functionality of their knee. It is a 42-item questionnaire, including five subscales: symptoms, pain, activities of daily living, sports/recreation and quality of life. The maximum score a patient can achieve is 100, and the minimum score is zero, indicating severe knee problems. KOOS has been verified in assessing patients of various age populations, ranging from young to elderly adultsThe VAS is a single-item measure that most commonly consists of a 100-mm horizontal line anchored with two opposite labels; patients mark a score on the scale using a vertical line