Trials / Terminated
TerminatedNCT01543737
Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
Single-blind Randomised Pragmatic Trial Comparing the Effectiveness of Two Hyaluronic Acid Viscosupplements, DUROLANE® (Single Injection) Versus HYALGAN® (Three Injections) for Symptomatic Tibiofemoral Osteoarthritis of the Knee.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 290 (actual)
- Sponsor
- Bioventus LLC · Industry
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess whether a single injection hyaluronic acid (HA) product is not inferior to a 3 injection HA product at 24 weeks (6 months), in terms of effectiveness in reducing pain when walking in patients suffering from symptomatic tibiofemoral osteoarthritis of the knee.
Detailed description
non-inferiority study of two HA products commercially availalble
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 3ml hyaluronic acid (DUROLANE) | DUROLANE Hyaluronic acid 20mg/ml |
| DEVICE | 2ml hyaluronic acid, (HYALGAN) | HYALGAN Hyaluronic acid 10mg/ml |
Timeline
- Start date
- 2012-02-01
- Primary completion
- 2014-02-01
- Completion
- 2014-02-01
- First posted
- 2012-03-05
- Last updated
- 2016-02-12
Locations
17 sites across 2 countries: France, Monaco
Source: ClinicalTrials.gov record NCT01543737. Inclusion in this directory is not an endorsement.