Clinical Trials Directory

Trials / Completed

CompletedNCT02840422

Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections

Assessment of Patients Quality of Life Suffering From Knee Osteoarthritis Treated With Three Intra-articular Injections of ARTHRUM H 2% Over a Period of Six Months

Status
Completed
Phase
Study type
Observational
Enrollment
138 (actual)
Sponsor
LCA Pharmaceutical · Industry
Sex
All
Age
40 Years
Healthy volunteers
Not accepted

Summary

The reduction of functional limits and disablilities induced by knee osteoarthritis as well as improvement of patients quality of life is a public health need registered amongst the priorities established by the French law of August 9th 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products. This clinical trial in real life on ARTHRUM H 2% device aims to analyse patients quality of life treated by intraarticular injections, eventually for several years, by difference of usual clinical trials. This open, prospective, multicentric study aims to analyse, in patient care, the impact of three intraarticular injections of ARTHRUM H 2% on quality of life over a period of 6 months (D180) in the symptomatic treatment of knee osteoarthritis.

Detailed description

Parameters used to determine treatment outcomes include: "Short-Form 12 Health Survey" (SF-12), Pain score of the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC A)

Conditions

Interventions

TypeNameDescription
DEVICEARTHRUM H 2%ARTHRUM H 2%

Timeline

Start date
2016-02-03
Primary completion
2016-12-08
Completion
2017-07-28
First posted
2016-07-21
Last updated
2024-01-19

Source: ClinicalTrials.gov record NCT02840422. Inclusion in this directory is not an endorsement.