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

NCT02840422 | Completed

• 1 other identifier: 140515
• Study Type: observational
• Target: 138
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic acid; Knee osteoarthritis; Quality of life

Outcome Measures

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)

  6 months

Secondary Outcomes (3)

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

  6 months

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

  6 months

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

  6 months

Interventions

ARTHRUM H 2% DEVICE

ARTHRUM H 2%

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men or Women aged aver 40 ans suffering fromm knee osteoarthritis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LCA Pharmaceutical: lead

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• CHRISTIAN PASCARETTI, MD

  Le Ronceray Rhumatologie

  STUDY DIRECTOR

• Paolo INSALACO, MD

  Le Ronceray Rhumatologie

  STUDY DIRECTOR

• ANTOINE LESORT, MD

  Hopital Prive des Peupliers

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 21, 2016
• Study Start: February 3, 2016
• Primary Completion: December 8, 2016
• Study Completion: July 28, 2017
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share