Influence of the Radiological Stage on the Efficiency of Viscosupplementation in Basal Thumb Arth… (NCT03622736) | Clinical Trial Compass
CompletedNot Applicable
Influence of the Radiological Stage on the Efficiency of Viscosupplementation in Basal Thumb Arthritis
France122 participantsStarted 2016-03
Plain-language summary
The rhizarthrose is the most frequent affection of the hand at the age fifty and beyond. For the moderate forms of the disease, the majority of the studies recommend the recourse to the viscosupplement because of its efficiency in the long term.
On the other hand, no study was focused on the impact of the anatomical severity on the clinical result of the treatment by intra-articular injection of hyaluronic acid.
The present research has for objective to study the influence of the radiological severity on the result of the viscosupplement, in the conditions of daily practice, in patients affected by rhizarthrose.
It is an open observational multicentrical prospective study realized by 10 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 55 patients will have been included by taking into account a risk of trial exits or of lost of sight of 10 %.The main criterion is the influence of the radiological stage on the answer to the treatment.
Duration of inclusion 6 months. Duration of follow-up 3 months. Total duration of the study 9 months.
Who can participate
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:
* Patients of both genders, of all ages
* Rhizarthrosis confirmed by radiography including frontal and KAPANDJI side radiographies performed during the last 6 months
* Patients requiring a viscosupplement based on the opinion of the investigator
* Patients were able to read and understand the information sheet, to give their enlighted consent and to respect follow up consultations
Exclusion Criteria:
* Patient with hypersensitivity to hyaluronic acid or mannitol
* Patient with a contraindication to the injection procedure : infected skin lesions on or close to an injection site, infectious disease ongoing
* Patient who received a viscosuplement during the last 3 months
* Patient who received an intra-articular injection of corticoids in the target articulation during the month before the inclusion
* Patient not talking french
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
Correlation between Dell's stage and the treatment response