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).

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-70
SponsorUniversiti Sains Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Hyaluronic Acid (HA)

    Drug

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

Treatment groups

62 Participants
are divided into 1 treatment group
Group A: DIART ONEExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 YEAR
2

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.

Time frame
1YEAR

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Sains Malaysia

Lead sponsor

Hospital Universiti Sains Malaysia

Collaborator

This trial is not recruiting at the moment. You can still explore other options: