Clinical trial NCT02840422: Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Hyaluronic acid
Knee osteoarthritis
Quality of life
Lead sponsor: LCA Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 138
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men or Women aged aver 40 ans suffering fromm knee osteoarthritis

Brief 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)

Eligibility criteria: 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.

Primary outcomes:
measure: To measure the 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)
timeFrame: 6 months
Secondary outcomes:
measure: To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)
timeFrame: 6 months
measure: To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)
timeFrame: 6 months
measure: To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Le Ronceray Rhumatologie
name: CHRISTIAN PASCARETTI, MD
role: STUDY_DIRECTOR
affiliation: Le Ronceray Rhumatologie
name: Paolo INSALACO, MD
role: STUDY_DIRECTOR
affiliation: Hopital Prive des Peupliers
name: ANTOINE LESORT, MD
role: STUDY_CHAIR
References: