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A Comparative Study of Intra-articular Polynucleotide and Hyaluronic acid in Bilateral Knee Osteoarthritis: A Prospective Randomized Controlled Trial

A Comparative Study of Intra-articular Polynucleotide and Hyaluronic acid in Bilateral Knee Osteoarthritis: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250211006
Enrollment
30
Registered
2025-02-11
Start date
2025-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Currently, various injectable treatments are available for knee osteoarthritis. However, at Songklanagarind Hospital, only HA injections are available. Therefore, understanding the effectiveness of other injectable treatments compared to HA is essential. If this study demonstrates that PN-based injections provide comparable or superior therapeutic outcomes to HA, including PN in the hospital&#039

Interventions

OSTENIL is an isotonic solution of highly purified hyaluronan (sodium hyaluronate) specifically developed for the treatment of osteoarthritis. It contains 20 mg/2 ml of sodium hyaluronate and is admin
Active Comparator Drug,Experimental Drug
Ostenil,Conjuran

Sponsors

Prince of Songkla University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age 40 years or older, 2.Diagnosed with knee osteoarthritis (OA) with a severity level of I-III based on the Kellgren-Lawrence (KL) classification, assessed using standard standing knee X-rays before study enrollment, 3. Experiencing knee pain from OA that has not responded to at least 3 months of initial treatment, such as medication or physical therapy, 4. Knee pain severity score of at least 40 out of 100 on the Visual Analogue Scale (VAS), 5. Able to understand and complete questionnaires.

Exclusion criteria

Exclusion criteria: 1. Complete loss of knee joint space on X-ray or knee osteoarthritis classified as KL grade IV, 2. History of severe knee injury or previous knee surgery, 3. History of infection, rheumatoid arthritis, or other inflammatory joint diseases, 4. Received intra-articular knee injections within the past 3 months, 5. Underwent physical therapy, acupuncture, massage, or shockwave therapy for knee pain within the past 2 weeks, 6. History of allergy to intra-articular injection medications, 7. Blood coagulation disorders or use of anticoagulants and/or antiplatelet medications within the past week, 8. Skin lesions or dermatological conditions around the knee, such as psoriasis or eczema

Design outcomes

Primary

MeasureTime frame
pain scores 6 weeks visual analog scale

Secondary

MeasureTime frame
functional outcome 6 weeks The Knee injury and Osteoarthritis Outcome Score (KOOS),functional outcome 6 weeks The Knee Society Score (KSS),functional outcome 6 weeks The EuroQol Visual Analogue Scale (EQ-VAS),patient satisfaction 6 weeks Numeric Rating Scale,complications 6 weeks Incidence rate

Countries

Thailand

Contacts

Public ContactChirathit Anusitviwat

Faculty of Medicine, Prince of Songkla University

pchirathit@gmail.com0817344269

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026