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).

Официальное название

Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis

Обзор

This study aims to evaluate the effectiveness of a single HA injection in improving pain, function, and quality of life in patients with knee OA over a 12-month period. By focusing on a single-arm open-label design, this study will provide practical insights into the real-world application of this treatment approach.

Подробное описание

Single-arm, open-label studies play a crucial role in the clinical research ecosystem. These studies are often conducted to:

1. Assess the performance of a novel HA formulation (e.g., different molecular weights, cross-linking technologies). 2. Gather "real-world" evidence in broader, less restrictive patient populations. 3. Provide preliminary data to support the design of larger, more expensive RCTs. 4. 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.

Вмешательства

• Препарат Hyaluronic Acid (HA)
  single injection of hyaluronic acid ( Diart) into the affected knee

Первичные конечные точки

• Functional assessment of patient with osteoarthritic knee included in this study [Срок оценки: 1 YEAR]
• Assessment of pain score in knee osteoarthritic patient [Срок оценки: 1YEAR]

Критерии участия

Критерии включения

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.

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Univerisiti Sains Malaysia (HUSM) — Kota Bharu

Публикации

• Suppan VKL, Tew MM, Muthusamy H, Voon JM, Ramli NAMN, Phuah ASJ, Murugaiah D. Long-term functional and clinical outcomes of intraarticular double-cross-linked high molecular weight hyaluronic acid (Crespine Gel Plus) injection in knee osteoarthritis: a one year prospective study. BMC Musculoskelet Disord. 2026 Feb 9;27(1):209. doi: 10.1186/s12891-026-09588-1. PMID 41664047

Идентификаторы

NCT: NCT07736781 · DIART ONE GRANT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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