Research Title: Long Term Functional Outcome of a Single Hyaluronic Acid Injection in Improving Symptoms and Function in Patients With Knee Osteoarthritis - A Single-Arm Open-Label Study (DIART ONE).
Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Single-arm, open-label studies play a crucial role in the clinical research ecosystem. These studies are often conducted to:
- Assess the performance of a novel HA formulation (e.g., different molecular weights, cross-linking technologies).
- Gather "real-world" evidence in broader, less restrictive patient populations.
- Provide preliminary data to support the design of larger, more expensive RCTs.
- Investigate outcomes in specific patient subpopulations (e.g., severe OA, different age groups).
1. To compare mean differences VAS Score 0,1,3,6,12 months. 2. To study comparison WOMACS mean differences. 3. To document the safety and tolerability of a single HA injection in a real-world clinical setting.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiekontakt
- Navn: SASSIDHAREN PONNALAGU, MEDICAL DEGREE
- Telefonnummer: +60102922046
- E-mail: sassidharen6@gmail.com
Undersøgelse Kontakt Backup
- Navn: Amran Prof. Dr A Shokri, master in orthopedics
- Telefonnummer: +60 12-900 9272
- E-mail: amrankb@usm.my
Studiesteder
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Kelantan
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Kota Bharu, Kelantan, Malaysia, 16150
- Hospital Univerisiti Sains Malaysia (HUSM)
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
i. Adults aged 40-75 years with a clinical and radiographic diagnosis of knee OA (Kellgren-Lawrence grade II-III).
ii. Persistent knee pain (≥4 on a 10-point Visual Analogue Scale [VAS]) for at least 3 months.
iii. Failure to achieve adequate pain relief with conservative treatments (e.g., NSAIDs, physical therapy).
iv. Willingness to provide informed consent and comply with study procedures.
Exclusion Criteria:
i. Severe OA (Kellgren-Lawrence grade IV). ii. History of knee surgery or HA injection within the past 6 months. iii. Inflammatory arthritis (e.g., rheumatoid arthritis, gout). iv. Contraindications to HA injections (e.g., infection, allergy to HA products).
v. Significant comorbidities that may interfere with study participation (e.g., uncontrolled diabetes, morbid obesity, severe cardiovascular disease).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: DIART ONE
Treatment Arm will receive a single HA injection to reduce pain and improving knee function in patients with knee OA over 12 months.
Outcomes will be assessed, including pain (VAS), function (WOMAC), and safety ( adverse events)
|
single injection of hyaluronic acid ( Diart) into the affected knee
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Functional assessment of patient with osteoarthritic knee included in this study
Tidsramme: 1 YEAR
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WOMAC osteoarthritis index is going to be used to assess the functionality of the patient with osteoarthritic knee, included in the study.
Assessment is done 0, 1, 3, 6,12 months
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1 YEAR
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Assessment of pain score in knee osteoarthritic patient
Tidsramme: 1YEAR
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The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 0, 1, 3, 6,12 months.
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1YEAR
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: AMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC, Universiti Sains Malaysia
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- DIART ONE GRANT
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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