Back to results

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

Primary Purpose

Knee Osteoarthritis

Status

Unknown status

Phase

Phase 4

Locations

Thailand

Study Type

Interventional

Intervention

Hyruan-One

Hylan G-F 20

Normal saline

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Hyruan-One, Hylan G-F 20, Hyaluronic acid, Knee osteoarthritis, Pain level

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

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

Sites / Locations

Thammasat UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

H group

S group

N group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pain level

visual analog scale for pain (0-100) in between groups

Change from pre-injection pain level at 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

visual analog scale for pain (0-100)

Modified WOMAC

measure modified WOMAC score (0-96)

Lequesne index

measure Lequesne index for knee osteoarthritis (4-24)

SF-36

measure short from health survey 36 items

Time up and go test

recorded time Up and Go test (minutes)

Complications

assess complications after injection by phone

Full Information

NCT ID

NCT03484091

First Posted

February 24, 2018

Last Updated

March 24, 2018

Sponsor

Thammasat University

1. Study Identification

Unique Protocol Identification Number

NCT03484091

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2018 (Anticipated)

Primary Completion Date

March 1, 2019 (Anticipated)

Study Completion Date

June 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Thammasat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Osteoarthritis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

A double-blind, placebo controlled RCT

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

276 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

H group

Arm Type

Experimental

Arm Description

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

Arm Title

S group

Arm Type

Active Comparator

Arm Description

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

Arm Title

N group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Hyruan-One

Intervention Description

single dose intra-articular injection

Intervention Type

Drug

Intervention Name(s)

Hylan G-F 20

Other Intervention Name(s)

Synvisc

Intervention Description

single dose intra-articular injection

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

single dose intra-articular injection

Primary Outcome Measure Information:

Title

Pain level

Description

visual analog scale for pain (0-100) in between groups

Time Frame

6 months after injection

Title

Change from pre-injection pain level at 6 months

Description

compare visual analog scale for pain (0-100) between pre-injection and post-injection

Time Frame

6 months

Secondary Outcome Measure Information:

Title

pain level in any time pints

Description

visual analog scale for pain (0-100)

Time Frame

post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks

Title

Modified WOMAC

Description

measure modified WOMAC score (0-96)

Time Frame

post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

Title

Lequesne index

Description

measure Lequesne index for knee osteoarthritis (4-24)

Time Frame

post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

Title

SF-36

Description

measure short from health survey 36 items

Time Frame

post-injection 2 weeks, 1, 2, 3,4, 5, 6 months

Title

Time up and go test

Description

recorded time Up and Go test (minutes)

Time Frame

post-injection 1, 3, 6 months

Title

Complications

Description

assess complications after injection by phone

Time Frame

post-injection 1, 2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nattapol Tammachote

Phone

+662-9269775

tammachotemd@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nattapol Tammachote, MD

Organizational Affiliation

Thammasat University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thammasat University

City

Khlong Luang

State/Province

Pathum Thani

ZIP/Postal Code

12120

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nattapol Tammachote, MD

Phone

6629269775

tammachotemd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs