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

Knee Osteoarthritis Clinical Trial

— IRADYN  

Official title:

Open, Non-comparative, Multicentre Clinical Investigation to Evaluate the Performance and Safety of the Medical Device IRADYN® (Polymerized Polynucleotides) Intra-articularly Administered in Subjects With Osteoarthritis of the Knee

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05206474
• Other study ID #: OPIRA/0121/MD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 7, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: January 2022
• Source: I.R.A. Istituto Ricerche Applicate S.p.A.
• Contact: Dioniso Franco Barattini, MD
• Phone: +40774012684
• Email: franco.barattini[@]tigermedgrp.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Romania	Centrul de kinetoterapie si Masaj Banat	Timisoara	Timis
Romania	Fizio Center	Timisoara	Timis

Sponsors (2)

Lead Sponsor	Collaborator
I.R.A. Istituto Ricerche Applicate S.p.A.	Opera CRO, a TIGERMED Group Company

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	AE, SAE, ADE, SADE, DD incidence	Adverse Event, Serious Adverse events, Adverse Device Event, Serious Adverse Device Event, Device Deficiency incidence	14 weeks
Other	Patient Global Tolerability	Percentage of patients with "very good" evaluations in the Patient Global Tolerability assessed at all visits.	14 weeks
Primary	Change in Range of Motion (ROM)	Change in Range of Motion (ROM) parameters, measured in degrees, using a goniometer (Active Knee Flexion - AKF, Passive Knee Flexion - PKF, Active Knee Extension - AKE, Passive Knee Extension - PKE)	14 weeks compared with baseline
Primary	Change in Visual Analogue Scale (VAS) for pain (at rest)	Visual Analogue Scale (VAS) for pain at rest is a 100 mm chart-line scale for the mentioned situation on which the subject must draw a mark on the scale to emphasize the intensity of the pain.; Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.	14 weeks compared to baseline
Secondary	Absolute change in Visual Analogue Scale (VAS) for pain (on moving and on pressing)	Absolute change in VAS for pain (on moving and on pressing) at all visits compared to Baseline Visit. Visual Analogue Scale (VAS) for pain under pressure and at movement is a 100 mm chart-line scale for each of the mentioned situations on which the subject must draw a mark on the scale to emphasize the intensity of the pain.; Minimum score is 0 and it means no pain. Maximum score is 100 and represents the maximum pain that patient can suffer.	Up to 14 weeks
Secondary	Absolute change in Knee injury and Osteoarthritis Outcome Score (KOOS)	KOOS consists of 5 subscales: Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.	6 weeks and 14 weeks compared to baseline
Secondary	Physician Efficacy Global Evaluation	Percentage of patients with "very good efficacy" evaluations in the Physician Efficacy Global Evaluation assessed at week 14.	14 weeks
Secondary	Evaluation of NSAIDs consumption at all visits	Incidence of Non-steroidal anti-inflammatory drugs (NSAIDs) consumption from first visit to final visit.	up to 14 weeks