NCT01618708

A Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Primary Osteoarthritis of the Hip

A Pivotal, Multicenter, Double Blind Study of the Safety and Effectiveness of Synvisc-One® (Hylan G-F 20) in Patients With Mild to Moderate Primary Osteoarthritis of the Hip

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.

Conditions

• Osteoarthritis, Hip

Interventions

Type	Name	Description
DEVICE	Synvisc-One (hylan G-F 20)	6-mL IA injection
DEVICE	Placebo	6 mL injection of phosphate buffered saline

Timeline

• Start date: 2012-09-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-06-13
• Last updated: 2016-07-11
• Results posted: 2016-07-11

Locations

48 sites across 2 countries: United States, Canada