Trials / Completed
CompletedNCT04293861
Evaluation of the Evolution of Biological and Imaging Markers of Bone and Cartilage Degradation in Patients With Knee Osteoarthritis Receiving Intra-articular Injections of a Hyaluronan Derivative HYMOVIS®
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Fidia Farmaceutici s.p.a. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This pilot study MOKHA is aimed to evaluate the beneficial effect of HYMOVIS® on cartilage of patients suffering of knee osteoarthritis as revealed by using scientifically sound, objective measurements of biological and MRI-based imaging markers.
Detailed description
This study is a post-marketing, open-label, prospective and multicentric pilot study in 50 patients suffering from knee OA. Investigators will be rheumatologists or articular disease specialists from public or academic hospitals located in Belgium and France. In each investigating center, the same injector will perform all the VS.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | HYMOVIS | HYMOVIS is a clear hydrogel obtained by hydration of the HA-based derivative named HYADD4p5. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. |
Timeline
- Start date
- 2015-04-01
- Primary completion
- 2017-06-06
- Completion
- 2017-06-06
- First posted
- 2020-03-03
- Last updated
- 2020-03-06
Locations
8 sites across 2 countries: Belgium, France
Source: ClinicalTrials.gov record NCT04293861. Inclusion in this directory is not an endorsement.