Knee OsteoarthritisPhase 4NCT03484091
Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis
A Phase 4 study testing Hyruan-One, Hylan G-F 20 and Normal saline in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial summary
We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hyruan-One, Hylan G-F 20 and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2018to 31 Dec 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months
- Gave informed consent
- Can do questionnaires
Who cannot join
- Severe deformity (varus or valgus from a mechanical axis more than 10 degrees
- Allergy to hyaluronic acid
- Pain in the hip or ankle
- Post-traumatic or post surgery of lower extremity
- Post-infection of the knee
- Previous hyaluronic acid injection within 6 months
- Pregnancy or lactation
- Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Khlong Luang, Changwat Pathum Thani, 12120
About this study
Official title: Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial
We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hyruan-One, Hylan G-F 20, Normal saline
- Keywords
- Hyruan-One, Hylan G-F 20, Hyaluronic acid, Knee osteoarthritis, Pain level
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyruan-OneDrug
single dose intra-articular injection
Hylan G-F 20Drug
Also called Synvisc
single dose intra-articular injection
Normal salineDrug
single dose intra-articular injection
| Study group | Role | What they receive |
|---|---|---|
| H group | Experimental | Single dose of Hyruan-One 3 mL intra-articular knee injection. Receives: Drug: Hyruan-One |
| S group | Active comparator | Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection. Receives: Drug: Hylan G-F 20 |
| N group | Placebo comparator | Single dose of normal saline 6 mL intra-articular knee injection. Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain level
visual analog scale for pain (0-100) in between groups
Measured: 6 months after injection
Change from pre-injection pain level at 6 months
compare visual analog scale for pain (0-100) between pre-injection and post-injection
Measured: 6 months
Secondary outcomes (6)
pain level in any time pints
visual analog scale for pain (0-100)
Measured: post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
Modified WOMAC
measure modified WOMAC score (0-96)
Measured: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Lequesne index
measure Lequesne index for knee osteoarthritis (4-24)
Measured: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
SF-36
measure short from health survey 36 items
Measured: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Time up and go test
recorded time Up and Go test (minutes)
Measured: post-injection 1, 3, 6 months
Complications
assess complications after injection by phone
Measured: post-injection 1, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start1 Apr 2018
- Primary completion27 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double-blind, placebo controlled RCT
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
- Investigators
- Nattapol Tammachote, MD, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484091
- Sponsor's protocol ID
- OrthoTU09
- Status last verified
- Mar 2018
- First submitted
- 24 Feb 2018
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial
- ClinicalTrials.gov ID
- NCT03484091
- Acronym / sponsor ID
- OrthoTU09
- Conditions
- Knee Osteoarthritis
- Keywords
- Hyruan-One, Hylan G-F 20, Hyaluronic acid, Knee osteoarthritis, Pain level
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Mar 2018 (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.
We compare the efficacy of intra-articular injection of Hyruan-One with Hylan G-F 20 and placebo (NSS) controlled in a double-blind RCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A double-blind, placebo controlled RCT
| Arm | Type | Receives |
|---|---|---|
| H group | Experimental | Drug: Hyruan-OneSingle dose of Hyruan-One 3 mL intra-articular knee injection. |
| S group | Active comparator | Drug: Hylan G-F 20Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection. |
| N group | Placebo comparator | Drug: Normal salineSingle dose of normal saline 6 mL intra-articular knee injection. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months
- Gave informed consent
- Can do questionnaires
Key exclusion criteria (8 listed)
- Severe deformity (varus or valgus from a mechanical axis more than 10 degrees
- Allergy to hyaluronic acid
- Pain in the hip or ankle
- Post-traumatic or post surgery of lower extremity
- Post-infection of the knee
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 |
|---|---|---|
| Hyruan-Onesingle dose intra-articular injection | Drug | H group |
| Hylan G-F 20Also: Synviscsingle dose intra-articular injection | Drug | S group |
| Normal salinesingle dose intra-articular injection | Drug | N group |
Primary outcome
Pain level
Time frame: 6 months after injection
visual analog scale for pain (0-100) in between groups
Change from pre-injection pain level at 6 months
Time frame: 6 months
compare visual analog scale for pain (0-100) between pre-injection and post-injection
6 secondary outcomes
pain level in any time pints
Time frame: post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
Modified WOMAC
Time frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Lequesne index
Time frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
SF-36
Time frame: post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Time up and go test
Time frame: post-injection 1, 3, 6 months
Complications
Time frame: post-injection 1, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Nattapol Tammachote, MD principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hyruan-One, Hylan G-F 20 and Normal saline in people with Knee Osteoarthritis, run by Thammasat University at 1 site in Thailand.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 Thailand. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain level (time frame: 6 months after injection). 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?
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 22 Sep 2025.