Treatment of Temporomandibular Joint Osteoarthritis by an Intra-articular Injection of Hyaluronic Acid. Study of Patient Satisfaction Predictive Factors, 6 Months After a Single Injection of Hyaluronic Acid.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Labrha
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- clinical factors associated with the treatment response in temporomandibular joint arthritis
Study Overview
Brief Summary
The arthritis of temporomandibular joint is the most frequent degenerative disease of the jaw joint. Several clinical studies recommend the recourse to the viscosupplement because of its efficiency in the long term.
The present research has for objective to find clinical factors predictive of success or failure of viscosupplementation in ATM such as clinical severity before injection, the presence of a limited mouth opening or lenght of symptoms.
It is an open observational monocentrical prospective study. The recruitment is competitive and the study will be ended when 44 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 6 months. Total duration of the study 12 months.
Detailed Description
Forty patients presenting an ATM 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, J90 and J180 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, target side, previous treatments, evaluation of pain at chewing and palpation (scale of Likert : 11 points), the inter-incisive distance during the maximal opening.
The informations collected during J90 and the final consultation (J180) are: the evaluation of pain at chewing and palpation (scale of Likert 11 points), the perception by the patient of the efficiency of the treatment (scale of Likert 4 points), patient satisfaction score, variation of its consumption of analgesic or of AINS (scale of Likert 5 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients of both genders, of all ages
- •Hallux rigidus confirmed by radiography including frontal and side radiographies performed during the last 12 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 6 months
- •Patient who received an intra-articular injection of corticoids in the target articulation during the last 3 month before the inclusion
- •Patient not talking french
Outcomes
Primary Outcomes
clinical factors associated with the treatment response in temporomandibular joint arthritis
Time Frame: 6 months
Assessment of since how long the patient has these pains (in months)
Secondary Outcomes
- clinical factors associated with the treatment response in temporomandibular joint arthritis(6 months)