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

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: ARTHRUM H 2%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or women aged over 40; Suffering from symptomatic knee osteoarthritis radiologically confirmed less than 12 months ago and stage I, II or III according to KELLGREN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale Patient able to understand the trial procedure and give his/her consent to take part, in writing; Patient geographically stable during the trial; Patient affiliated to the French social security regime or benefiting from such a French regime. Exclusion Criteria: Inflammatory arthritis; Progressive infectious condition of the knee being studied; Previous treatment with viscosupplementation for at least one year; Injection of corticoids into the knee studied for less than two months; Known hypersensivity to hyaluronic acid or substances with similar activity; Pregnant or breast-feeding women; Patient under guardianship or tutorship or under juridicial protection; Patient currently taking part in another clinical research study.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ARTHRUM H 2%|ARTHRUM H 2%|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyse impact of physical component summary (PCS) improvement, on patient quality of life suffering from knee osteoarthritis after treatment by three intraarticular injections of ARTHRUM H 2% from D0 (inclusion) to D180 (end of trial) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study quality of life variation, Short-Form 12 Health Survey (SF-12) on physical component summary (PCS) | From D0 to D90 From D90 to D180 | 6 months | 
| To study quality of life variation, Short-Form 12 Health Survey (SF-12) on mental component summary (MCS) | From D0 to D90 From D0 to D180 From D90 to D180 | 6 months | 
| To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A) | From D0 to D90 From D0 to D180 From D90 to D180 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyaluronic acid, Knee osteoarthritis, Quality of life