Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Patients Quality of Life Treated With Three ARTHRUM H 2% Joint Injections (ART-QUALIVIE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02840422
Recruitment Status : Unknown
Verified July 2016 by LCA Pharmaceutical.
Recruitment status was:  Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Collaborator:
BIOSTATEM
Information provided by (Responsible Party):
LCA Pharmaceutical

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.


Condition or disease Intervention/treatment
Knee Osteoarthritis Device: ARTHRUM H 2%

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)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 126 participants
Time Perspective: Prospective
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 Start Date : January 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis


Intervention Details:
  • Device: ARTHRUM H 2%
    ARTHRUM H 2%


Primary Outcome Measures :
  1. 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) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men or Women aged aver 40 ans suffering fromm knee osteoarthritis
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840422


Sponsors and Collaborators
LCA Pharmaceutical
BIOSTATEM
Investigators
Layout table for investigator information
Study Director: CHRISTIAN PASCARETTI, MD Le Ronceray Rhumatologie
Study Director: Paolo INSALACO, MD Le Ronceray Rhumatologie
Study Chair: ANTOINE LESORT, MD Hopital Prive des Peupliers
Layout table for additonal information
Responsible Party: LCA Pharmaceutical
ClinicalTrials.gov Identifier: NCT02840422    
Other Study ID Numbers: 140515
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by LCA Pharmaceutical:
Hyaluronic acid
Knee osteoarthritis
Quality of life
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases