Hallux Rigidus, Unspecified Foot Clinical Trial
Official title:
Does the Radiological Stage Allow to Predict the Efficacy of an Intra-articular Injection of Hyaluronic Acid Among Patients Affected by a Hallux Rigidus ?
The hallux rigidus is the most frequent type of arthrosis at the age of 50 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 Hallux rigidus.
It is an open observational multicentrical prospective study realized by 20 investigators
rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study
will be ended when 66 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.
Sixty patients presenting a hallux rigidus asserted by radiography and justifying a
viscosupplement, without other selection criterion than the opinion of the investigator
concerning the legitimacy of a viscosupplement and the agreement of the patient participating
in the study.
The data collected during the consultations at J0 and J90 will be inputed by the investigator
in the paper version of the CRF.
The informations collected during the initial consultation (J0) are: demographic (sex, age,
weight, size), pathological (history of the disease, bilaterality, surgery of the big toe,
evaluation of pain at J0 (scale of Likert : 11 points), treatments with analgesic aim, use of
an orthosis), radiologics (Dell's stage), techniques (type of radiological or ultrasound
guide).
The informations collected during the final consultation (J90) are: the evaluation of pain at
J90 (scale of Likert 11 points), the perception by the patient of the efficiency of the
treatment at J90 (scale of Likert 4 points), variation of its consumption of analgesic or of
AINS (scale of Likert 3 points).
A descriptive analysis will be performed to characterize the demographic data, the history of
the disease and its treatments, as well as the clinical and radiological data of the patients
in the date of the inclusion.
The answer to the treatment will be estimated by 2 modalities (YES/NO) from the answer of the
patients at the question " How do you judge the efficiency of the treatment ?": yes if the
patients answered "Effective" or "very effective", no if they answered "little effective" or
"not effective".
The influence of the radiological stage on the answer to the treatment will be studied (main
criterion). The influence of radiological stage on the level of pain at J0 and on the
reduction of pain between J0 and J90 will also be studied.
The coefficients of the multivariate models (ANCOVA and mixed model) will be considered as
significant if their p-value is inferior to the threshold of 5%.
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