At a glance
ClinicalIndex Comparison RecordN/ACompleted· 357 enrolled
Drug / intervention
Synvisc-One (hylan G-F 20) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Synvisc-One (hylan G-F 20) and Placebo for Osteoarthritis, Hip. Completed, enrolled 357 participants across 48 sites in 2 countries.
Detailed Summary
The primary objective of this study was to demonstrate any changes in assessments of pain for participants receiving Synvisc-One compared to control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteoarthritis, Hip
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 2012
Enrollment StartSep 2012
Primary CompletionJun 2015
TodayJul 2026
First PostedJun 13, 2012
Enrollment StartSep 1, 2012
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.1 years ago
Interventions
Synvisc-One (hylan G-F 20)device
6-mL IA injection
Placebodevice
6 mL injection of phosphate buffered saline