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

Sponsor

Thammasat University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03484091

Collaborator

(none)

276

Enrollment

Location

Arms

Anticipated Duration (Months)

19.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Hyruan-One Drug: Hylan G-F 20 Drug: Normal saline	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

276 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A double-blind, placebo controlled RCTA double-blind, placebo controlled RCT

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Apr 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Jun 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: H group Single dose of Hyruan-One 3 mL intra-articular knee injection.	Drug: Hyruan-One single dose intra-articular injection
Active Comparator: S group Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.	Drug: Hylan G-F 20 single dose intra-articular injection Other Names: Synvisc
Placebo Comparator: N group Single dose of normal saline 6 mL intra-articular knee injection.	Drug: Normal saline single dose intra-articular injection

Arm

Intervention/Treatment

Experimental: H group

Single dose of Hyruan-One 3 mL intra-articular knee injection.

Drug: Hyruan-One

single dose intra-articular injection

Active Comparator: S group

Single dose of Hylan G-F 20 (Synvisc) 6 mL intra-articular knee injection.

Drug: Hylan G-F 20

single dose intra-articular injection

Other Names:

Synvisc

Placebo Comparator: N group

Single dose of normal saline 6 mL intra-articular knee injection.

Drug: Normal saline

single dose intra-articular injection

Outcome Measures

Primary Outcome Measures

Pain level [6 months after injection]
visual analog scale for pain (0-100) in between groups
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

Secondary Outcome Measures

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
Time up and go test [post-injection 1, 3, 6 months]
recorded time Up and Go test (minutes)
Complications [post-injection 1, 2 weeks]
assess complications after injection by phone

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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