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

NCT06228274 | Completed

• 1 other identifier: 131001
• Study Type: observational
• Target: 218
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Knee Osteoarthritis

Keywords

Hyaluronic Acid; Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• 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

  6 months

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

  6 months

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

  6 months

• 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

  6 months

• 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

  6 months

Study Arms (1)

ARTHRUM 2.5% single injection

Device: ARTHRUM 2.5%

Interventions

ARTHRUM 2.5% DEVICE

ARTHRUM 2.5%

ARTHRUM 2.5% single injection

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 over 40 * Suffering from knee osteoarthritis

You may qualify if:

• 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.

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 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.

Sponsors & Collaborators

• LCA Pharmaceutical: lead
• BIOSTATEM: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• DOMINIQUE BARON, MD

  Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel

  STUDY DIRECTOR

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: January 29, 2024
• Study Start: March 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: March 1, 2017
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share