Assessment of Safety and Efficacy of ARTHRUM 2.5% for Treatment of Painful Osteoarthritis of the Knee
NCT ID: NCT06228274
Last Updated: 2024-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
218 participants
OBSERVATIONAL
2013-03-31
2017-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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ARTHRUM 2.5% single injection
ARTHRUM 2.5%
ARTHRUM 2.5%
Interventions
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ARTHRUM 2.5%
ARTHRUM 2.5%
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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BIOSTATEM
UNKNOWN
LCA Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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DOMINIQUE BARON, MD
Role: STUDY_DIRECTOR
Centre de reeducation et de readaptation fonctionnelles en milieu marin de Trestel
Other Identifiers
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131001
Identifier Type: -
Identifier Source: org_study_id
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