Clinical trial NCT05206474: To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee Osteoarthritis
Joint Inflammation
Iradyn
Polynucleotides
Filler
Lead sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Sponsor class: NETWORK
Collaborators: name: Opera CRO, a TIGERMED Group Company
First posted: 2022-01-25
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label, non-comparative
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in Range of Motion (ROM)
timeFrame: 14 weeks compared with baseline
measure: Change in Visual Analogue Scale (VAS) for pain (at rest)
timeFrame: 14 weeks compared to baseline
Secondary outcomes:
measure: Absolute change in Visual Analogue Scale (VAS) for pain (on moving and on pressing)
timeFrame: Up to 14 weeks
measure: Absolute change in Knee injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: 6 weeks and 14 weeks compared to baseline
measure: Physician Efficacy Global Evaluation
timeFrame: 14 weeks
measure: Evaluation of NSAIDs consumption at all visits
timeFrame: up to 14 weeks
Other outcomes:
measure: AE, SAE, ADE, SADE, DD incidence
timeFrame: 14 weeks
measure: Patient Global Tolerability
timeFrame: 14 weeks
Locations:
city: Timisoara
country: Romania
facility: Centrul de kinetoterapie si Masaj Banat
state: Timis
city: Timişoara
country: Romania
facility: Fizio Center
state: Timis
Study officials:
affiliation: Fizio Center
name: George Puenea, MD
role: PRINCIPAL_INVESTIGATOR
References: