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Completed

NCT Number: NCT06228274

Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee

ARTHRUM 2.5% MONO-INJECTION as symptomatic treatment by joint injection extends the conservative therapeutic arsenal in Knee osteoarthritis.

The reduction of functional limits and disabilities induced by knee osteoarthritis as well as improvement of quality of life of patients is a public health need registered amongst the priorities established by the French law of 9 August 2004 relative to Public Health policy. However, the response to this need is not limited to treatment with health products.

This prospective, open, multi-centre trial of the real-life efficacy of ARTHRUM 2.5% aims to demonstrate the efficacy of a single joint injection of this treatment on pain, during 6 months, in the symptomatic treatment of patients suffering from 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: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC Index), Evaluation of Quality of Life and Handicap and Assessment of therapeutic efficacy

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 unilateral knee osteoarthritis confirmed radiologically less than six months ago and stage I, II or III according to KELGREEN (knee in extension) and with minimal pain on walking (WOMAC A1) of two points on the LIKERT scale and functional discomfort for at least three months
  • 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 three months
  • Known hypersensitivity to hyaluronic acid or substances with similar activity
  • Anticoagulant treatment in progress
  • Insulin-dependent / type I diabetes
  • Pregnant or breast-feeding women
  • Patient under guardianship or tutorship or under judicial protection
  • Patient currently taking part in another clinical research study.

Treatment and study plan

ARTHRUM 2.5%

Device

ARTHRUM 2.5%

Primary outcomes

  1. Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels

    Time frame: 6 months

Secondary outcomes

  1. Safety of ARTHRUM 2.5% under actual conditions of prescription and use: frequency, nature and severity of reported side effects assessed by Likert scale on four levels

    Time frame: 6 months

  2. Reduction of consumption of Analgesics and NSAIDs after ARTHRUM 2.5% intra-articular injection assessed by Likert scale on four levels.

    Time frame: 6 months

  3. Study of ARTHRUM 2.5% intra-articular impact on the Patient's activity assessed by Likert scale on five levels

    Time frame: 6 months

  4. Study of ARTHRUM 2.5% intra-articular impact on the Patient's quality of life by responding one questionnaire assessed by Likert scale on six levels

    Time frame: 6 months

  5. Study of ARTHRUM 2.5% intra-articular impact on the Patient's handicap level by responding one questionnaire assessed by Likert scale on five levels

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

LCA Pharmaceutical

Industry

Collaborators

  • BIOSTATEM

Registry information

Official study title

Measurement of the Real Life Efficacy of ARTHRUM 2.5% Health Product Single Injection in Patients Suffering From Knee Osteoarthritis

Acronym: ART-ONE75

Important dates

Study start
2013
Primary completion
2015
Study completion
2017
First posted
Jan 29, 2024
Registry last updated
Jan 29, 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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