Durolane SJ for Treatment of Rhizarthrosis (NCT02676284) | Clinical Trial Compass
CompletedNot Applicable
Durolane SJ for Treatment of Rhizarthrosis
Spain36 participantsStarted 2013-05
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Pain Measured by the VAS Scale