Interventistic Clinical Investigation on the Use of Medical Device in Subjects With Mild-moderate Osteoarticular Pain

NCT ID: NCT06422169

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2025-05-08

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Artofill

One vial for intra-articular infiltration every 7 days, for three consecutive weeks. After the injection it is necessary to keep the infiltrated joint at rest for at least 24 hours. In addition, as with all invasive joint treatments, the patient is advised to avoid any physical activity 2-3 days after the injection. Do not repeat the treatment before 7 days from the previous one.

Group Type: EXPERIMENTAL

ArToFILL

Intervention Type: DEVICE

ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.

Interventions

ArToFILL

ArToFILL is an injectable medical device (class III) intended for use as a temporary filler in joints. It is a sterile, non-pyrogenic, colorless and transparent hyaluronic acid gel of non-animal origin. ArToFILL is a hydrogel consisting of a mixture of two different molecular weights of hyaluronic acid, for a total HA concentration of 2.7 %.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PromoPharma spa

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Vecchio

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco", P.O. "G. Rodolico"

Locations

U.O. Recupero e riabilitazione funzionale P.O. "G.Rodolico", Azienda Ospedaliero Universitaria Policlinico "G. Rodolico - San Marco"

Catania, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Michele Vecchio

Role: CONTACT

michele.vecchio@unict.it

+39 0953782702

Facility Contacts

Michele Vecchio

Role: primary

michele.vecchio@unict.it

+39 0953782702

Other Identifiers

ARTO/09/2023

Identifier Type: -

Identifier Source: org_study_id