This trial is active, not recruiting.

Condition knee osteoarthritis
Treatment arthrum h 2%
Sponsor LCA Pharmaceutical
Collaborator BIOSTATEM
Start date January 2016
End date March 2017
Trial size 126 participants
Trial identifier NCT02840422, 140515


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

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 Outcomes

To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on physical component summary (PCS)
time frame: 6 months
To study quality of life variation, "Short-Form 12 Health Survey" (SF-12) on mental component summary (MCS)
time frame: 6 months
To study pain variation of score A from Western Ontario McMaster Universities Osteoarthritis (WOMAC A)
time frame: 6 months

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

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
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)
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by LCA Pharmaceutical.