The aim of this study was to compare single injection HYAJOINT Plus Synovial Fluid Supplement used on the single and repeat treatment of knee osteoarthritis that has the same safety and effectiveness as three-injection hyaluronan, Hyalgan.
The study was a random, evaluator-blinded, controlled, single center clinical trial. Recruiting patients who have been suffered from the osteoarthritis pain under conventional nonpharmacologic therapy or analgesics for a long time and randomly divided into two groups, HYAJOINT Plus or Hyalgan group, when the inclusion criteria was met and the inform consent was obtained. They were followed for 56 weeks including visits at 4, 12, 26, 39, and 52 weeks post-treatment for the safety and effectiveness evaluation. After complete 52-week visit, subjects would received HYAJOINT Plus on the target knee. These subjects were followed for 4 weeks to assess the safety of repeat treatment or cross reactions of the use from three-injections to single-injection hyaluronan treatment. The primary endpoints were the incidence of any adverse events during the study, as well as the objective assessment of pain visual analog scale at baseline and every visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
140
Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
Three-injection, 20 mg / 2 ml (1%) linear hyaluronan
VAS pain score
The change from baseline in a Visual analog scale score for pain. The VAS scale uses a 100 mm line labelled at '0' with 'no pain' and '100' with 'worst pain'.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
The reported adverse events
Any adverse events reported by the patients during the study period and physical examination findings by the evaluator after injections and at each follow-up visit.
Time frame: 1, 3, 6, 9 and 12 months post-injection
WOMAC, Likert Scale
a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
VAS stiffness score
The change from baseline in the Visual analog scale score for stiffness. The VAS scale uses a 100 mm line labelled at '0' with 'no stiffness' and '100' with 'worst stiffness'.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
Timed Up-and-Go test (TUG)
A simple measurement of time in seconds for a subject to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down.
Time frame: Baseline, 1, 3, 6, 9 and 12 months post-injection
VAS satisfaction score
Patients rate their treatment satisfaction based on a 100 mm VAS. The VAS scale uses a 100 mm line labelled at '0' with 'least satisfaction' and '100' with 'highest satisfaction'.
Time frame: 1, 3, 6, 9 and 12 months post-injection
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