Radiological Stage and Efficacy of an Intra-articular Injection of Hyaluronic Acid for the Treatment of Hallux Rigidus

NCT03622723 | Completed

• 1 other identifier: 2015-A01904-45
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hallux Rigidus, Unspecified Foot

Keywords

hallux rigidus; viscosupplementation; hyaluronic acid; metartarsophalangeal joint; foot arthritis; osteoarthritis of the big toe

Outcome Measures

Primary Outcomes (1)

• Correlation between the radiological stage and the treatment response

  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

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

Sponsors & Collaborators

• Labrha: lead

Study Sites (1)

LABRHA

Lyon, 69001, France

Location

MeSH Terms

Conditions

Hallux Rigidus

Condition Hierarchy (Ancestors)

Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Joint 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: April 19, 2016
• Primary Completion: May 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)