Clinical Trial
To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee (IRADYN)
ClinicalTrials.gov ID: NCT05206474
Sponsor: I.R.A. Istituto Ricerche Applicate S.p.A.
Information provided by: I.R.A.Istituto Ricerche Applicate S.p.A. (Responsible Party)
Last Update Posted: 2022-03-15
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.
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
The complete documentation is considered strictly confidential.
To consult the public database Clinicaltrials.gov go to https://clinicaltrials.gov/ by entering the code NCT05206474 (Publicly Accessible Database Registration Number).
You will find the information relating to the OPIRA/0121/MD study for Iradyn.