Influence of the Radiological Stage on the Efficiency of Viscosupplementation in Basal Thumb Arthritis

NCT03622736 | Completed

• 1 other identifier: 2015-AO1874-45
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

The rhizarthrose is the most frequent affection of the hand at the age fifty 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 rhizarthrose. It is an open observational multicentrical prospective study realized by 10 investigators rheumatologists and liberal orthopedic surgeons. The recruitment is competitive and the study will be ended when 55 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.

Conditions

Osteoarthritis Thumb

Keywords

Rhizarthrosis; basal thumb arthritis; Osteoarthritis Thumb; viscosupplementation; hyaluronic acid; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Correlation between Dell's stage and the treatment response

  The variation between injection D0 and D90 of the thumb pain on 11 point-Likert scale (0-10)

  3 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

Fifty patients presenting a rhizarthrose 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
• Rhizarthrosis confirmed by radiography including frontal and KAPANDJI 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

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 3 months
• Patient not talking french

Sponsors & Collaborators

• Labrha: lead

Study Sites (1)

LABRHA

Lyon, 69001, 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

• thierry CONROZIER, MD

  Labrha

  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 9, 2018
• Study Start: March 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)