Status:
UNKNOWN
To Evaluate the Performance and Safety of the Medical Device IRADYN in Subjects With Osteoarthritis of the Knee
Lead Sponsor:
I.R.A. Istituto Ricerche Applicate S.p.A.
Collaborating Sponsors:
Opera CRO, a TIGERMED Group Company
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-80 years
Phase:
NA
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 polymerize...
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 Osteoarthri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05206474
Start Date
March 7 2022
End Date
October 1 2022
Last Update
March 15 2022
Active Locations (2)
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1
Centrul de kinetoterapie si Masaj Banat
Timișoara, Timiș County, Romania, 300254
2
Fizio Center
Timișoara, Timiș County, Romania, 300425