At a glance
ClinicalIndex Comparison RecordN/ACompleted· 349 enrolled
Drug / intervention
ARTZ +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 Multicenter, Randomized, Double-blind, Parallel, Active-controlled Clinical Trial With Non-inferiority Comparison to Evaluate Efficacy and Safety of Intra-articular Injection of DUROLANE® vs. ARTZ® in Treatment of Knee Osteoarthritis
In Brief
A clinical study evaluating ARTZ and DUROLANE for Knee Osteoarthritis. Completed, enrolled 349 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine the comparative safety and efficacy of intra-articular injection of hyaluronic acid, obtained from two different sources, in the treatment of osteoarthritic pain of the knee.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesChina
CollaboratorsSmith & Nephew, Inc.
Timeline
N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionAug 2011
Study CompletionFeb 2012
TodayJul 2026
First PostedFeb 14, 2011
Enrollment StartJan 1, 2011
Primary CompletionAug 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.4 years ago
Interventions
ARTZdevice
Hyaluronic acid (five 2.5 mL injections)
DUROLANEdevice
Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)