Osteoarthritis Thumb Clinical Trial
— INSTINCTOfficial title:
Influence of the Radiological Stage on the Efficiency of Intra-articular Injection of Hyaluronic Acid in Basal Thumb Arthritis
NCT number | NCT03622736 |
Other study ID # | 2015-AO1874-45 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | August 2017 |
Verified date | August 2018 |
Source | Labrha |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 122 |
Est. completion date | August 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | LABRHA | Lyon |
Lead Sponsor | Collaborator |
---|---|
Labrha |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation between Dell's stage and the treatment response | The variation between injection D0 and D90 of the thumb pain on 11 point-Likert scale (0-10) | 3 months |
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