Treatment of Temporomandibular Joint Osteoarthritis by Viscosupplement. Satisfaction Predictive Factors

NCT03627429 | Completed

• 1 other identifier: 2016-A00177-44
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis of Temporomandibular Joint; Temporomandibular Arthritis

Keywords

temporomandibular arthritis; temporomandibular joint; rheumatoid arthritis; viscosupplementation; hyaluronic acid

Outcome Measures

Primary Outcomes (1)

• clinical factors associated with the treatment response in temporomandibular joint arthritis

  Assessment of since how long the patient has these pains (in months)

  6 months

Secondary Outcomes (2)

• clinical factors associated with the treatment response in temporomandibular joint arthritis

  6 months

• clinical factors associated with the treatment response in temporomandibular joint arthritis

  6 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Forty patients having a hallux rigidus asserted radiologically and justifying according to the opinion of the rhumalologist or the surgeon a viscosupplementation. The study is realized in the conditions of daily practice, it modifies not at all the therapeutic care of the patient

You may qualify if:

• 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

You may not qualify if:

• 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 not talking french

Sponsors & Collaborators

• Labrha: lead

Study Sites (1)

BARON

Lannion, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• DOMINIQUE BARON, MD

  CH LANNION

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2018
• First Posted: August 13, 2018
• Study Start: April 30, 2016
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)