To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee

NCT ID: NCT05206474

Last Updated: 2022-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-07
• Study Completion Date: 2022-10-01

Brief Summary

The benefits of single or repetitive administration (1 to 6) can have similar result in terms of muscular strength and patients' quality of life improvement, benefiting of the advantages of polymerized polynucleotides (IRADYN) formulation.

Detailed Description

Of all osteoarthritis' localization into human body, knee OA represents the most common OA localization.

On 2014 the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis (ESCEO) has suggested as first step of pharmacological treatment for knee osteoarthritis (OA) a background therapy with chronic symptomatic slow-acting drugs for osteoarthritis (SYSADOAs). In this class of natural compounds, hyaluronic acid (HA) has evidenced its efficacy after intra-articular (IA) administration in patient with mild to moderate knee OA .

The filler used in this clinical investigation is using polymerised polynucleotides (PDRN) that has hydrophilic properties of polyanions; therefore, it can bind water molecules and provide a moisturising and lubricant effect. Its viscoelastic properties allow it to compensate for the loss of synovial fluid viscosity in the event of degenerative or trauma joint alterations. These actions reduce the mechanical stress on joints, thereby decreasing friction. This improves joint function and movement with significant relief of pain commonly associated with this problem. Moreover, the enzymatic degradation of the polynucleotide chain releases nucleotides into the synovial cavity. These nucleotides can bind water molecules and share the same viscoelastic properties as the entire chain, helping extend the duration of the effect.

The benefits of single or repetitive administration (1 to 6) can have similar result in terms of muscular strength and patients' quality of life improvement, benefiting of the advantages of polymerized polynucleotides (IRADYN) formulation.

Conditions

Knee Osteoarthritis

Study Design

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

Study Groups

IRADYN

One group, all patients will receive IRADYN® (intra-articular administration).

One course of IRADYN® at baseline, consisting of a mono-dose intra-articular administration (2ml).

From week 1 to week 6, injection will be performed, if necessary, during the visit, following the dosage reported in the instruction for use / summary of product characteristic.

Group Type: EXPERIMENTAL

IRADYN

Intervention Type: DEVICE

One course of IRADYN® at baseline, consisting of a mono-dose intra-articular administration (2 ml).

From week 1 to week 6, injection will be performed, if necessary, during the visit, following the dosage reported in the instruction for use / summary of product characteristic.

Interventions

IRADYN

One course of IRADYN® at baseline, consisting of a mono-dose intra-articular administration (2 ml).

From week 1 to week 6, injection will be performed, if necessary, during the visit, following the dosage reported in the instruction for use / summary of product characteristic.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Aged between 40 and 80 years (inclusive, ≥ 40 and ≤ 80 years);
• Symptomatic knee osteoarthritis as defined by the American College of Rheumatology (ACR) criteria (for subjects with OA at both knees, the most painful one will be included in the study only, respecting Kellgren-Lowrance grade II or III);
• Ambulant without assistance;
• Kellgren-Lawrence grade II or III on X-ray performed at maximum 6 months before screening;
• Visual Analogue Scale (VAS) score knee pain ≥40 at screening and 30 days before;
• Oral/parenteral corticosteroid or NSAIDs (≤10 mg prednisone) administration at least 30 days before screening.
• Signed Informed consent

Exclusion Criteria

• Unstable knee;
• Varus or valgus ≥ 15 degrees;
• Active malignancy;
• Knee trauma or lose body parts 1 year before screening;
• Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
• Use of potent analgesics 15 days (different from ≤ 10 mg prednisone) before screening;
• Intra-articular HA, polymerized polynucleotides or corticosteroid injection within 6 months before screening;
• Arthroscopic or knee open surgery within 12 months before screening;
• Body Mass Index (BMI) ≥ 40 kg/m2;
• Active infection around the injection site;
• Use of anticoagulants or history of thrombocytopenia;
• Concomitant use of disease-modifying antirheumatic drugs (DMARDs), anaesthetics;
• Known sensitivity to polymerized polynucleotides;
• Pregnancy, breast feeding.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Opera CRO, a TIGERMED Group Company

OTHER

Sponsor Role: collaborator

I.R.A. Istituto Ricerche Applicate S.p.A.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Puenea, MD

Role: PRINCIPAL_INVESTIGATOR

Fizio Center

Locations

Centrul de kinetoterapie si Masaj Banat

Timișoara, Timiș County, Romania

Fizio Center

Timișoara, Timiș County, Romania

Countries

Romania

Central Contacts

Dioniso Franco Barattini, MD

Role: CONTACT

franco.barattini@tigermedgrp.com

+40774012684

Ioana Gâlcă

Role: CONTACT

ioana.galca@TigermedGrp.com

+40741107508

Facility Contacts

Roxana Cerbulescu, MD

Role: primary

roxyac2003@yahoo.com

+0724338781

George Puenea, MD

Role: primary

george.puenea@yahoo.com

+40722438747

Other Identifiers

OPIRA/0121/MD

Identifier Type: -

Identifier Source: org_study_id