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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03484091
• Other study ID #: OrthoTU09
• Status: Recruiting
• Phase: Phase 4
• First received: February 24, 2018
• Last updated: March 24, 2018
• Start date: April 1, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: March 2018
• Source: Thammasat University
• Contact: Nattapol Tammachote
• Phone: +662-9269775
• Email: tammachotemd[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 276
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Hyruan-One
single dose intra-articular injection
• Hylan G-F 20
single dose intra-articular injection
• Normal saline
single dose intra-articular injection

Locations

Country	Name	City	State
Thailand	Thammasat University	Khlong Luang	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain level	visual analog scale for pain (0-100) in between groups	6 months after injection
Primary	Change from pre-injection pain level at 6 months	compare visual analog scale for pain (0-100) between pre-injection and post-injection	6 months
Secondary	pain level in any time pints	visual analog scale for pain (0-100)	post-injection 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24 weeks
Secondary	Modified WOMAC	measure modified WOMAC score (0-96)	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Secondary	Lequesne index	measure Lequesne index for knee osteoarthritis (4-24)	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Secondary	SF-36	measure short from health survey 36 items	post-injection 2 weeks, 1, 2, 3,4, 5, 6 months
Secondary	Time up and go test	recorded time Up and Go test (minutes)	post-injection 1, 3, 6 months
Secondary	Complications	assess complications after injection by phone	post-injection 1, 2 weeks