Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee (ART-ONE75)
January 18, 2024 updated by: LCA Pharmaceutical
Measurement of the Real Life Efficacy of ARTHRUM 2.5% Health Product Single Injection in Patients Suffering From Knee Osteoarthritis
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
Study Overview
Detailed Description
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
Study Type
Observational
Enrollment (Actual)
218
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
- Men or women aged over 40
- Suffering from knee osteoarthritis
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ARTHRUM 2.5% single injection
|
ARTHRUM 2.5%
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Efficacy of ARTHRUM 2.5% single joint injection on pain assessed by Likert scale on five levels
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
6 months
|
|
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
|
6 months
|
|
Study of ARTHRUM 2.5% intra-articular impact on the Patient's activity assessed by Likert scale on five levels
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: DOMINIQUE BARON, MD, Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
September 1, 2015
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
July 19, 2016
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 29, 2024
Study Record Updates
Last Update Posted (Actual)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 18, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.