Conditions: Osteoarthritis
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 237
Healthy volunteers: no

Brief summary:
Primary Objective:

* To evaluate the change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (walking pain) at 26 weeks compared to the Baseline score
* To evaluate the safety using the incidence, severity, seriousness, relatedness, and frequency of all treatment emergent Adverse Events (AEs)

Secondary Objectives:

* To evaluate the change in WOMAC A1 subscore (walking pain) between baseline and weeks 8, and 12
* To evaluate the change in WOMAC A, B and C score between baseline and weeks 8, 12 and 26
* To evaluate the change in Patient Global Assessment (PTGA) score between baseline and weeks 8, 12 and 26
* To evaluate the change in Clinical Observer Global Assessment (COGA) score between baseline and weeks 8, 12 and 26
* To evaluate the change in concomitant Osteoarthritis (OA) therapy over 26 weeks and between baseline and weeks 1, 2, 8, 12 and 26

Detailed description:
Duration of study period for each participants was 26-28 weeks.

Arms:
arm 1: Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.

Interventions: intervention 1: Hylan G-F 20
Intervention descriptions: intervention 1: Intra-articular injection (pre-filled glass syringe)

Protocol document: