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Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis

Comparison of Single Intra-articular Injection of Hyruan-One With Hylan G-F 20 in Knee Osteoarthritis: A Randomized Double-blind, Saline-controlled Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03484091
Enrollment
276
Registered
2018-03-30
Start date
2018-04-01
Completion date
2023-12-31
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Osteoarthritis

Keywords

Hyruan-One, Hylan G-F 20, Hyaluronic acid, Knee osteoarthritis, Pain level

Brief 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.

Interventions

DRUGHyruan-One

single dose intra-articular injection

DRUGHylan G-F 20

single dose intra-articular injection

DRUGNormal saline

single dose intra-articular injection

Sponsors

Thammasat University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

A double-blind, placebo controlled RCT

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months * Gave informed consent * Can do questionnaires

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain level6 months after injectionvisual analog scale for pain (0-100) in between groups
Change from pre-injection pain level at 6 months6 monthscompare visual analog scale for pain (0-100) between pre-injection and post-injection

Secondary

MeasureTime frameDescription
Lequesne indexpost-injection 2 weeks, 1, 2, 3,4, 5, 6 monthsmeasure Lequesne index for knee osteoarthritis (4-24)
SF-36post-injection 2 weeks, 1, 2, 3,4, 5, 6 monthsmeasure short from health survey 36 items
pain level in any time pintspost-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeksvisual analog scale for pain (0-100)
Complicationspost-injection 1, 2 weeksassess complications after injection by phone
Time up and go testpost-injection 1, 3, 6 monthsrecorded time Up and Go test (minutes)
Modified WOMACpost-injection 2 weeks, 1, 2, 3,4, 5, 6 monthsmeasure modified WOMAC score (0-96)

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026