CompletedNot Applicable

Treatment of Temporomandibular Joint Osteoarthritis by Viscosupplement. Satisfaction Predictive Factors

France36 participantsStarted 2016-04-30

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

clinical factors associated with the treatment response in temporomandibular joint arthritis

Timeframe: 6 months

Trial details

NCT IDNCT03627429

SponsorLabrha

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-04

View on ClinicalTrials.gov More Arthritis of Temporomandibular Joint trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.