Radar degli Studi Clinici

Change in Knee Function as Assessed by the Western Ontario and McMaster Universities Index (WOMAC)

Assessment of change from baseline in target knee function using the WOMAC Osteoarthritis Index. The WOMAC is a proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee including pain, stiffness, and physical functioning of the joints. The response to the questions is in the form of a checked box associated with the response; None, Mild, Moderate, Severe and Extreme.

12 months

Change in Knee Pain as Assessed by VAS

Assessment of change from baseline in target knee pain using the Visual Analog Scale (VAS). The VAS is a method for the assessment of the intensity of pain. The VAS is a horizontal line, 100 mm in length and anchored by word descriptors at each end (no pain, very severe pain). The patient marks on the line at the point that represents their current state. The VAS score is determined by measuring in millimeters from the left hand end to the point of the mark. The score ranges from "0" or no pain to "100" very severe pain.

12 months

MRI Assessment of Target Knee

Assessment of knee organ tissues and structure by comparing change in MRI scoring using WORMS and partial MRI Osteoarthritis Knee Score (MOAKS)

12 months

PCS of the SF-12 Questionnaire

Evaluation of the change from baseline in physical component score (PCS) of the SF-12v2 questionnaire.

12 months

WOMAC Total Score

Evaluation of the efficacy of TG-C with regard to knee function via WOMAC total score

24 Months

Health Assessment Questionnaire Disability Index

Evaluation of the change from baseline in the disability index of the Health Assessment Questionnaire (HAQ-DI)

12 months