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Not yet recruitingPhase 3

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).

Key facts

Phase
Phase 3

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 70 years old?

Source: NCT07736781, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Universiti Sains Malaysia
Trial code
NCT07736781
Record updated
30 July 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: Adults aged 40-75 years with a clinical and radiographic diagnosis of knee OA (Kellgren-Lawrence grade II-III); Persistent knee pain (≥4 on a 10-point Visual Analogue Scale [VAS]) for at least 3 months; Failure to achieve adequate pain relief with conservative treatments (e.g., NSAIDs, physical therapy); Willingness to provide informed consent and comply with study procedures.

Exclusion: 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); Significant comorbidities that may interfere with study participation (e.g., uncontrolled diabetes, morbid obesity, severe cardiovascular disease).

ClinicalTrials.gov NCT07736781