The tolerability and efficacy of Hyalubrix® in osteoarthritis
Completed
- Conditions
- OsteoarthritisMusculoskeletal DiseasesPolyarthrosis
- Registration Number
- ISRCTN42690497
- Lead Sponsor
- Fidia Farmaceutici S.p.A. (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1300
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
1. Infections located in the body area to be treated
2. Established sensitivity to hyaluronic acid or to other components of the product
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event notification.<br><br>Timepoints:<br>Visit 0: at baseline<br>Visit 2: one week after baseline<br>Visit 3: one week after visit 2<br>Final visit: two weeks after visit 3
- Secondary Outcome Measures
Name Time Method 1. Evaluation of the medical device performance on pain during motion and at rest, determined by VAS and HAQ<br>2. Quality of life evaluation (by means of EuroQoL)<br><br>Timepoints:<br>Visit 0: at baseline<br>Visit 2: one week after baseline<br>Visit 3: one week after visit 2<br>Final visit: two weeks after visit 3