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

Phase 4

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Hylan G-F 20; Drug: Normal saline; Drug: Hyruan-One

• Registration Number: NCT03484091
• Lead Sponsor: Thammasat University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-24
• Status Verified: 2018-03
• Study First Submitted QC: 2018-03-24
• Last Update Submitted: 2018-03-24
• Study First Posted: 2018-03-30
• Last Update Posted: 2018-03-30
• Study Start: 2018-04-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Symptomatic primary knee osteoarthritis with failed conservative treatment at least 3 months
• Kellgren-Lawrence grade I-III
• Gave informed consent
• Can do questionnaires

Exclusion Criteria

• Severe deformity (varus or values from mechanical axis more than 5 degrees
• Allergy to hyaluronic acid
• Pain on hip or ankle
• Post-traumatic or post surgery of lower extremity
• Post infection of knee
• Previous hyaluronic acid injection within 6 months
• Pregnancy or lactation
• Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S group	Hylan G-F 20	Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.
N group	Normal saline	Single dose of normal saline 6 mL intra-articular knee injection.
H group	Hyruan-One	Single dose of Hyruan-One 3 mL intra-articular knee injection.

Primary Outcome Measures

Name	Time	Method
Change from pre-injection pain level at 6 months	6 months	compare visual analog scale for pain (0-100) between pre-injection and post-injection
Pain level	6 months after injection	visual analog scale for pain (0-100) in between groups

Secondary Outcome Measures

Name	Time	Method
Time up and go test	post-injection 1, 3, 6 months	recorded time Up and Go test (minutes)
pain level in any time pints	post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks	visual analog scale for pain (0-100)
Modified WOMAC	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months	measure modified WOMAC score (0-96)
Lequesne index	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months	measure Lequesne index for knee osteoarthritis (4-24)
SF-36	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months	measure short from health survey 36 items
Complications	post-injection 1, 2 weeks	assess complications after injection by phone

Trial Locations

Locations (1)

Thammasat University; 🇹🇭 Khlong Luang, Pathum Thani, Thailand