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

NCT05206474 | Unknown

• 1 other identifier: OPIRA/0121/MD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Joint Inflammation; Iradyn; Polynucleotides; Filler

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Absolute change in Visual Analogue Scale (VAS) for pain (on moving and on pressing)

  Up to 14 weeks

• Absolute change in Knee injury and Osteoarthritis Outcome Score (KOOS)

  6 weeks and 14 weeks compared to baseline

• Physician Efficacy Global Evaluation

  14 weeks

• Evaluation of NSAIDs consumption at all visits

  up to 14 weeks

Other Outcomes (2)

• AE, SAE, ADE, SADE, DD incidence

  14 weeks

• Patient Global Tolerability

  14 weeks

Study Arms (1)

IRADYN

EXPERIMENTAL

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.

Device: IRADYN

Interventions

IRADYN 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.

IRADYN

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.A. Istituto Ricerche Applicate S.p.A.: lead
• Opera CRO, a TIGERMED Group Company: collaborator

Study Sites (2)

Centrul de kinetoterapie si Masaj Banat

Timișoara, Timiș County, 300254, Romania

Location

Fizio Center

Timișoara, Timiș County, 300425, Romania

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Arthritis

Condition Hierarchy (Ancestors)

Osteoarthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• George Puenea, MD

  Fizio Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dioniso Franco Barattini, MD

CONTACT

+40774012684; franco.barattini@tigermedgrp.com

Ioana Gâlcă

CONTACT

+40741107508; ioana.galca@TigermedGrp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Open-Label, non-comparative

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 25, 2022
• Study Start: March 7, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-01

Locations

RO (2)