N/A
N=36
Durolane SJ for Treatment of Rhizarthrosis
Rhizarthrosis
Bottom Line
View on ClinicalTrials.gov: NCT02676284 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Change From Baseline in Pain Measured by the VAS Scale — -2.00 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Durolane SJ (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zambon SAU
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Measured by the VAS Scale |
-2.00 | — |
| SECONDARY Change From Baseline in Biomechanical Function, Measured by the Quick DASH Questionnaire |
-10.8 | — |
Summary
The main objective of the trial is to assess the clinical changes in terms of physical examination, VAS Scale and the Quick-DASH questionnaire, and the biomechanical parameters in terms of mobility of the TMC joint, the grip strength of the hand and lateral pinch strength in patients with rhizarthrosis after administration of viscosupplementation.
The secondary objectives of the trial will be to assess the safety of the treatment with viscosupplementation, and the correlation between the clinical and biomechanical changes at the end of the trial.
Eligibility Criteria
Inclusion Criteria
- Subjects of both sexes aged 18 to 75 years.
- Diagnosis of Grade II-III rhizarthrosis in either hand, according to the criteria of Eaton and Littler.
- TMC joint pain lasting longer than 6 months and baseline pain value greater than or equal to 4 on the VAS scale (0 to 10) and less than 4 in the contralateral hand joint if there is pain.
Exclusion Criteria
- Anticoagulant medication
- Rheumatic disease involving the wrist, hand and fingers, such as rheumatoid arthritis or gout
- Active rheumatoid arthritis
- Previous surgery of the hand
- Systemic infectious processes
- Neoplastic disease
- Subjects with contraindications to hyaluronic acid
- Subjects with known hypersensitivity to hyaluronic acid or any of the components of the preparation under study
- Previous hyaluronic acid injections in the hand
- Subjects likely to miss the clinical follow-up visits
- Taking of analgesics 24 hours before scheduled clinical assessments
- Pregnant subjects
- Any condition that in the opinion of the physician recommends exclusion of the subject
Data sourced from ClinicalTrials.gov (NCT02676284). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.