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

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

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: 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)

• Study Type: Observational
• Enrollment (Actual): 138

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men or Women aged aver 40 ans suffering fromm knee osteoarthritis

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	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

Collaborators and Investigators

• Sponsor: LCA Pharmaceutical
• Collaborators: BIOSTATEM
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2016
• Primary Completion (Actual): December 8, 2016
• Study Completion (Actual): July 28, 2017

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 19, 2016
• First Posted (Estimated): July 21, 2016

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Knee osteoarthritis; Hyaluronic acid
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 140515

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO