Osteoarthritis Musculoskeletal Diseases Polyarthrosis
Conditions
Interventions
Four visits were scheduled:
Visit one: enrolment and start of therapy
Visit two: during study treatment
Visit three: during study treatment
Visit four: patient's final evaluation, 2 weeks from third
Sponsors
Fidia Farmaceutici S.p.A. (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suffering from degenerative or mechanical arthropathies who were candidates for being treated with Hyalubrix® 2. Patients aged 18 years or older, either sex 3. Patients who signed informed consent form
Exclusion criteria
Exclusion criteria: 1. Infections located in the body area to be treated 2. Established sensitivity to hyaluronic acid or to other components of the product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event notification. Timepoints: Visit 0: at baseline Visit 2: one week after baseline Visit 3: one week after visit 2 Final visit: two weeks after visit 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of the medical device performance on pain during motion and at rest, determined by VAS and HAQ 2. Quality of life evaluation (by means of EuroQoL) Timepoints: Visit 0: at baseline Visit 2: one week after baseline Visit 3: one week after visit 2 Final visit: two weeks after visit 3 | — |
Countries
Italy
Outcome results
None listed