Knee OsteoarthritisIRADYNNCT05206474
To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee
A study testing IRADYN in people with Knee Osteoarthritis, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 2 sites in Romania.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- IRADYN
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesRomania
- Study dates
- 7 Mar 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
Romania2 sites
Centrul de kinetoterapie si Masaj Banat
Timișoara, Timiș County, 300254
Roxana Cerbulescu, MD, +0724338781, roxyac2003@yahoo.com
Roxana Cerbulescu, MD
Fizio Center
Timișoara, Timiș County, 300425
George Puenea, MD, +40722438747, george.puenea@yahoo.com
George Puenea, MD
About this study
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 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.
Read the 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
- Being tested
- IRADYN
- Keywords
- Knee Osteoarthritis, Joint Inflammation, Iradyn, Polynucleotides, Filler
- Medical subject headings
- Osteoarthritis, Knee, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRADYNDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IRADYN |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 14 weeks compared to baseline
Secondary outcomes (4)
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.
Measured: Up to 14 weeks
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.
Measured: 6 weeks and 14 weeks compared to baseline
Physician Efficacy Global Evaluation
Percentage of patients with "very good efficacy" evaluations in the Physician Efficacy Global Evaluation assessed at week 14.
Measured: 14 weeks
Evaluation of NSAIDs consumption at all visits
Incidence of Non-steroidal anti-inflammatory drugs (NSAIDs) consumption from first visit to final visit.
Measured: up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start7 Mar 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label, non-comparative
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.
- Sponsor type
- Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Responsible party
- Sponsor
- Investigators
- George Puenea, MD, Principal investigator, Fizio Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206474
- Sponsor's protocol ID
- OPIRA/0121/MD
- Acronym
- IRADYN
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05206474
- Acronym / sponsor ID
- IRADYN / OPIRA/0121/MD
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Joint Inflammation, Iradyn, Polynucleotides, Filler
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- I.R.A. Istituto Ricerche Applicate S.p.A.Research network
- Collaborators
- Opera CRO, a TIGERMED Group Company
- Study start
- 7 Mar 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label, non-comparative
| Arm | Type | Receives |
|---|---|---|
| IRADYN | Experimental | Device: IRADYNOne 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (14 listed)
- Unstable knee;
- Varus or valgus ≥ 15 degrees;
- Active malignancy;
- Knee trauma or lose body parts 1 year before screening;
- Rheumatoid Arthritis, avascular necrosis, fibromyalgia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRADYNOne 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. | Device | IRADYN |
Primary outcome
Change in Range of Motion (ROM)
Time frame: 14 weeks compared with baseline
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)
Change in Visual Analogue Scale (VAS) for pain (at rest)
Time frame: 14 weeks compared to baseline
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.
4 secondary outcomes
Absolute change in Visual Analogue Scale (VAS) for pain (on moving and on pressing)
Time frame: Up to 14 weeks
Absolute change in Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 6 weeks and 14 weeks compared to baseline
Physician Efficacy Global Evaluation
Time frame: 14 weeks
Evaluation of NSAIDs consumption at all visits
Time frame: up to 14 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Puenea, MD principal investigator
Fizio Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRADYN in people with Knee Osteoarthritis, run by I.R.A. Istituto Ricerche Applicate S.p.A. at 2 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dioniso Franco Barattini, MD (+40774012684, franco.barattini@tigermedgrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Range of Motion (ROM) (time frame: 14 weeks compared with baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.