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Osteoarthritis Thumb

Influence of the Radiological Stage on the Efficiency of Viscosupplementation in Basal Thumb Arthritis

Sponsored by Labrha

About this trial

Last updated 7 years ago

Study ID

2015-AO1874-45

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
All
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 8 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status