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).
Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Single-arm, open-label studies play a crucial role in the clinical research ecosystem. These studies are often conducted to:
- Assess the performance of a novel HA formulation (e.g., different molecular weights, cross-linking technologies).
- Gather "real-world" evidence in broader, less restrictive patient populations.
- Provide preliminary data to support the design of larger, more expensive RCTs.
- 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: SASSIDHAREN PONNALAGU, MEDICAL DEGREE
- Phone Number: +60102922046
- Email: sassidharen6@gmail.com
Study Contact Backup
- Name: Amran Prof. Dr A Shokri, master in orthopedics
- Phone Number: +60 12-900 9272
- Email: amrankb@usm.my
Study Locations
-
-
Kelantan
-
Kota Bharu, Kelantan, Malaysia, 16150
- Hospital Univerisiti Sains Malaysia (HUSM)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: DIART ONE
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)
|
single injection of hyaluronic acid ( Diart) into the affected knee
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional assessment of patient with osteoarthritic knee included in this study
Time Frame: 1 YEAR
|
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
Time Frame: 1YEAR
|
The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 0, 1, 3, 6,12 months.
|
1YEAR
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: AMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC, Universiti Sains Malaysia
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DIART ONE GRANT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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