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).
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hyaluronic Acid (HA).
- Who it may be relevant to
- Registry conditions: Osteo Arthritis of the Knee. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Overview
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.
Detailed description
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.
Interventions
- Drug Hyaluronic Acid (HA)
single injection of hyaluronic acid ( Diart) into the affected knee
Primary outcome measures
- Functional assessment of patient with osteoarthritic knee included in this study [Time frame: 1 YEAR]
- Assessment of pain score in knee osteoarthritic patient [Time frame: 1YEAR]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- Hospital Univerisiti Sains Malaysia (HUSM) — Kota Bharu
Publications
- 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
Identifiers
NCT: NCT07736781 · DIART ONE GRANT