OA knee is a common degenerative diseases of the joint. * There are many methods to treat this condition. * Hyaluronic acid is one of the recomended treatment of OA knee. * There is no any study on MRI change after injection hyaluronic acid. * The Hypothesis is 25 mg of sodium hyaluronate (2.5 ml) would preserve the joint space in patient with osteoarthritis of the knee compared to placebo .
This will be the phase III randomized, double-blind, placebo-controlled trial of 52 weeks duration designed to evaluate the efficacy of sodium hyaluronate to placebo (saline), in adult with OA of the knee joints. Randomization will be stratified by Kellgren-Lawrence(KL) grade (garde2 or 3), by subjects X-ray. A total of 60 subjects are planed for enrollment in this study. The study will be conducted over approximately 52 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
25 mg sodium hyaluronate, 2 ml., intraarticular weekly for 5 weeks
Weerachai Kosuwon
Khon Kaen, Changwat Khon Kaen, Thailand
MRI will be analysed with semiquantitative whole organ scoring method (WORMS) c
Time frame: 6 months
WOMAC, VAS, side effects
Time frame: 14 months
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