Osteo Arthritis of the KneePhase 3NCT07736781
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).
A Phase 3 study testing Hyaluronic Acid (HA) in people with Osteo Arthritis of the Knee, run by Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Osteo Arthritis of the Knee
- What is being tested?
- Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Aug 2026to 30 Aug 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Hospital Univerisiti Sains Malaysia (HUSM)
Kota Bharu, Kelantan, 16150
About this study
Official title: 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.
Read the 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).
- 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.
- Conditions
- Osteo Arthritis of the Knee
- Being tested
- Hyaluronic Acid (HA)
- Keywords
- OSTEOARTHRITIS OF THE KNEE , DIART ONE
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Drug
single injection of hyaluronic acid ( Diart) into the affected knee
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Aug 2028 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis of the KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model 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. 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.
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universiti Sains Malaysia
- Responsible party
- Principal investigator, Amran Ahmed Shokri, Universiti Sains Malaysia
- Investigators
- AMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07736781
- Sponsor's protocol ID
- DIART ONE GRANT
- Status last verified
- Jul 2026
- First submitted
- 26 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To protect participant personal data
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.
PubMed 41664047
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Functional Outcome of a Single Hyaluronic Acid Injection in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07736781
- Acronym / sponsor ID
- DIART ONE GRANT
- Conditions
- Osteo Arthritis of the Knee
- Keywords
- OSTEOARTHRITIS OF THE KNEE , DIART ONE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Hospital Universiti Sains Malaysia
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Aug 2028 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model 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. 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.
| Arm | Type | Receives |
|---|---|---|
| DIART ONE | Experimental | Drug: Hyaluronic Acid (HA)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) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyaluronic Acid (HA)single injection of hyaluronic acid ( Diart) into the affected knee | Drug | DIART ONE |
Primary outcome
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 41664047Suppan 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. To protect participant personal data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC principal investigator
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hyaluronic Acid (HA) in people with Osteo Arthritis of the Knee, run by Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SASSIDHAREN PONNALAGU, MEDICAL DEGREE (+60102922046, sassidharen6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional assessment of patient with osteoarthritic knee included in this study (time frame: 1 YEAR). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07736781, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.