A Phase 2/3 interventional study of HYAJOINT Plus and Synvisc-One in Knee Osteoarthritis, sponsored by Kaohsiung Veterans General Hospital.. Completed at 1 site in Taiwan. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-19.
Sponsored by Kaohsiung Veterans General Hospital. · Phase 2/3, Interventional, and Treatment
Viscosupplementation has been widely used for the treatment of knee osteoarthritis (OA). There is no well controlled trial comparing one injection regimen of HA for the treatment of knee OA. The purpose of this study was to compare the efficacy and safety of one intraarticular injection of a novel crosslinked HA (HYAJOINT Plus) with Synvisc-One for the treatment of knee OA.
In a prospective, randomized controlled, double-blind trial with 6-month follow up, patients with knee OA (Kellgren-Lawrence grade 2 or 3) were randomized to receive one intraarticular injection of 3 ml HYAJOINT Plus (microbial fermented HA, 20 mg/ml) (N=66) or 6 ml Synvisc-One (avian derived HA, 8 mg/ml) (N=66). The primary outcome was change in the visual analog scale (VAS) pain (0-100mm) over 6 months. Secondary outcomes included The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Lequesne index, Timed Up-and-Go test (TUG), single leg stance test (SLS), use of rescue analgesics and patient satisfaction.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 132 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Kaohsiung Veterans General Hospital. is the lead sponsor of 102 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
average pain on knee movement of 30 mm or greater on a 100-mm VAS
Exclusion Criteria:
the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
Device: HYAJOINT Plus
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
Device: Synvisc-One
The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
Also known as: Hyaluronic acid
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
VAS pain score
the change from baseline in the VAS pain score over 6 months.
Time frame: at 1, 3 and 6 months postinjection
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: at 1, 3 and 6 months postinjection
Lequesne index
Maximal score is 24 and higher scores represent worse function.
Time frame: at 1, 3 and 6 months postinjection
Timed Up-and-Go test (TUG)
a simple measurement of time in seconds for a person to rise from an armchair, walk 3 meters, turn around, walk back to the chair, and sit down
Time frame: at 1, 3 and 6 months postinjection
Single-leg stance test (SLS)
by raising one foot up without touching it to the supported lower extremity with target knee OA and maintain balance for as long as possible.
Time frame: at 1, 3 and 6 months postinjection
satisfaction based on a 100 mm VAS
Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS
Time frame: at 1, 3 and 6 months postinjection
The reported adverse events
based on 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: at 1 week (safety records via phone call), 1, 3 and 6 months after the injection
Plan to share: No
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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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Kaohsiung Veterans General Hospital.