Clinical trial NCT06422169: Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain
Official title: Interventistic Monocentric Pre-market Clinical Investigation on the Use of Medical Device "ArToFILL" in Subjects With Mild-moderate Osteoarticular Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: PromoPharma spa
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Monocenter, prospective, open label, interventional clinical investigation evaluating the performance and safety of 3 intra-articular injections of ArToFILL for the treatment of mild-moderate osteoarticular pain.

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.

Primary outcomes:
measure: Reduction ≥ of 15 points on VAS scale, at the Study Termination Visit compared to baseline
timeFrame: Up to 180 days
Secondary outcomes:
measure: Clinical improvement assessed by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Up to 180 days
measure: Improved range of motion (ROM) of the knee joint
timeFrame: Up to 180 days
Other outcomes:
measure: Evaluation of the safety and tolerability of treatment of medical device.
timeFrame: 180 days
measure: Evaluation of the safety and tolerability of treatment of medical device.
timeFrame: Up to 180 days
Locations:
city: Catania
country: Italy
facility: U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"
Study officials:
affiliation: Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"
name: Michele Vecchio
role: PRINCIPAL_INVESTIGATOR
References: