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Completed

NCT Number: NCT02840422

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARTHRUM H 2%

Device

ARTHRUM H 2%

Primary outcomes

  1. 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)

    Time frame: 6 months

Secondary outcomes

  1. To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)

    Time frame: 6 months

    • From D0 to D90
    • From D90 to D180

  2. To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)

    Time frame: 6 months

    • From D0 to D90
    • From D0 to D180
    • From D90 to D180

  3. To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)

    Time frame: 6 months

    • From D0 to D90
    • From D0 to D180
    • From D90 to D180

Sponsors and collaborators

Lead sponsor

LCA Pharmaceutical

Industry

Registry information

Official study 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

Acronym: ART-QUALIVIE

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jul 21, 2016
Registry last updated
Jan 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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