Radiological Stage and Efficacy of an Intra-articular Injection of Hyaluronic Acid for the Treatment of Hallux Rigidus
Radiological Stage and Efficacy of an Intra-articular Injection of Hyaluronic Acid for the Treatment of 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%.
Inclusion Criteria:

 -  • Patients of both genders, of all ages

 -  Hallux rigidus confirmed by radiography including frontal and 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

 -  Patients that must undergo a surgical operation planned during 3 months following the
 injection susceptible to interfere with the follow-up or the evaluation