Overview

Evaluation of the performance and safety of ArToFILL in subjects with mild to moderate osteoarticular pain

Eligibility

Inclusion Criteria:

• Patient (males and females) aged between 18 and 84 years (limits included);
• Patient able to understand the nature and purpose of the study, including possible risks and side effects;
• Patient able to provide written Informed Consent, in accordance with good clinical practice and current legislation;
• Pain ≥ 40 mm on the VAS score in the target knee for at least 2 months;
• Patient with knee osteoarthritis assessed radiographically, grade 1 to 3 according to the Kellgren-Lawrence scale (K-L);
• Body Mass Index (BMI) ≤ 35;
• Patient who will benefit from this treatment;
• Patient available for the entire study period;
• Patient able to cooperate and meet the requirements of the clinical investigation plan.

Exclusion Criteria:

• Patient with knee osteoarthritis, assessed radiographically, grade 4 by the K-L scale;
• Patient presenting ongoing inflammation/infection at the level of the joint being investigated;
• Patient with abundant intra-articular effusion;
• Patient with symptoms of viral or bacterial infections or similar;
• Patient with insertion point of the joint infected or in the presence of a skin disease;
• Simultaneous treatment with disinfectants containing quaternary ammonium salts or chlorhexidine;
• Patient with known or potential allergy or hypersensitivity and/or history of allergic reactions to one of the components of the medical device;
• Concomitant treatments with thrombolytic or anticoagulant therapies, for less than 2 weeks prior to the screening visit;
• Intra-articular treatments carried out in the last 3 months (9 months if with products containing hyaluronic acid) of the target joint;
• Topical treatments of the target joint in progress or performed within 1 week of the screening visit;
• Taking NSAIDs and/or paracetamol as rescue treatment for more than two consecutive days;
• Surgical interventions of prosthetic replacement in the target joint;
• Physiotherapy and instrumental physical therapy treatments for the target joint performed in the last 2 weeks prior to the screening visit, and during the study period;
• Participation in another clinical trial within 60 days prior to the screening visit;
• Evidence of severe or uncontrolled systemic disease or any other significant disorder (e.g. haemophilia, bleeding disorders etc.); which do not allow participation in the study or could compromise the results.
• Patients who are pregnant or breastfeeding;
• Subject unable to follow clinical investigation procedures and follow-up visits;
• Any other medical condition which could influence participation in the clinical investigation or compromise its results.