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).

NCT07736781 | Not Yet Recruiting Phase 3

• 1 other identifier: DIART ONE GRANT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteo Arthritis of the Knee

Keywords

OSTEOARTHRITIS OF THE KNEE , DIART ONE

Outcome Measures

Primary Outcomes (2)

• Functional assessment of patient with osteoarthritic knee included in this study

  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

  1 YEAR

• Assessment of pain score in knee osteoarthritic patient

  The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 0, 1, 3, 6,12 months.

  1YEAR

Study Arms (1)

DIART ONE

EXPERIMENTAL

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)

Drug: Hyaluronic Acid (HA)

Interventions

Hyaluronic Acid (HA) DRUG

single injection of hyaluronic acid ( Diart) into the affected knee

DIART ONE

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Hospital Universiti Sains Malaysia: collaborator

Study Sites (1)

Hospital Univerisiti Sains Malaysia (HUSM)

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (1)

• 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 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• AMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

SASSIDHAREN PONNALAGU, MEDICAL DEGREE

CONTACT

+60102922046; sassidharen6@gmail.com

Amran Prof. Dr A Shokri, master in orthopedics

CONTACT

+60 12-900 9272; amrankb@usm.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR (DR)

Model Details: 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. Participants will receive a single intra-articular HA injection (Diart) and will be followed up at 0, 1, 3,6 and 12 months post-injection to assess outcomes.

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 30, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): August 30, 2028
• Study Completion (Estimated): August 30, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

MY (1)