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

Thammasat University276 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

276

Conditions

Knee Osteoarthritis

Interventions

Hyruan-OneDRUG

single dose intra-articular injection

Hylan G-F 20DRUG

single dose intra-articular injection

Normal salineDRUG

single dose intra-articular injection

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Symptomatic primary knee osteoarthritis with failed conservative treatment for at least 3 months * Gave informed consent * Can do questionnaires Exclusion Criteria: * Severe deformity (varus or valgus from a mechanical axis more than 10 degrees * Allergy to hyaluronic acid * Pain in the hip or ankle * Post-traumatic or post surgery of lower extremity * Post-infection of the knee * Previous hyaluronic acid injection within 6 months * Pregnancy or lactation * Underlying Rheumatoid arthritis, stroke, malignancy, venous occlusion

Locations (1)

Thammasat University

Khlong Luang, Changwat Pathum Thani, Thailand

Outcomes

Primary Outcomes

Pain level

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

Time frame: 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

Time frame: 6 months

Secondary Outcomes

pain level in any time pints

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

Modified WOMAC

measure modified WOMAC score (0-96)

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

Lequesne index

measure Lequesne index for knee osteoarthritis (4-24)

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

SF-36

measure short from health survey 36 items

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

Time up and go test

recorded time Up and Go test (minutes)

Time frame: post-injection 1, 3, 6 months

Complications

assess complications after injection by phone

Time frame: post-injection 1, 2 weeks

Data from ClinicalTrials.gov

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