Using ArToFILL for treating mild to moderate knee pain

Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain

This study is testing a new device called ArToFILL to see if it can help people with mild to moderate knee pain from osteoarthritis feel better after three injections.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years to 84 Years
• Sex: All
• Sponsor: PromoPharma spa (industry)
• Locations: 1 site (Catania)
• Trial ID: NCT06422169 on ClinicalTrials.gov

What this trial studies

This clinical investigation evaluates the performance and safety of ArToFILL, a medical device, through three intra-articular injections in patients suffering from mild to moderate osteoarticular pain. The study is monocenter, prospective, and open-label, focusing on individuals with knee osteoarthritis assessed radiographically. Participants will be monitored for their response to treatment and any potential side effects over the course of the study.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 84 with mild to moderate knee osteoarthritis and a pain score of 40 mm or higher on the VAS scale.

Not a fit: Patients with severe knee osteoarthritis (grade 4) or those with ongoing joint inflammation or infection will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients with knee osteoarthritis.

How similar studies have performed: While this approach is relatively novel, similar studies evaluating intra-articular treatments for osteoarthritis have shown promising results.

Eligibility criteria

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.

Where this trial is running

Catania

• U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco" — Catania, Italy (RECRUITING)

Study contacts

• Principal investigator: Michele Vecchio — Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
• Study coordinator: Michele Vecchio

Conditions: Osteoarthritis, Knee