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

Study Overview
=================
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.

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Hyruan-One
* Drug: Hylan G-F 20
* Drug: Normal saline


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A double-blind, placebo controlled RCT
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain level | visual analog scale for pain (0-100) in between groups | 6 months after injection | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Modified WOMAC | measure modified WOMAC score (0-96) | post-injection 2 weeks, 1, 2, 3,4, 5, 6 months | 
| Lequesne index | measure Lequesne index for knee osteoarthritis (4-24) | post-injection 2 weeks, 1, 2, 3,4, 5, 6 months | 
| SF-36 | measure short from health survey 36 items | post-injection 2 weeks, 1, 2, 3,4, 5, 6 months | 
| Time up and go test | recorded time Up and Go test (minutes) | post-injection 1, 3, 6 months | 
| Complications | assess complications after injection by phone | post-injection 1, 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyruan-One, Hylan G-F 20, Hyaluronic acid, Knee osteoarthritis, Pain level