Knee Osteoarthritis
Conditions
Keywords
Knee osteoarthritis, Hyaluronic acid, Viscosupplementation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEHYAJOINT Plus
The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
DEVICESynvisc-One
The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
Sponsors
Kaohsiung Veterans General Hospital.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* symptomatic knee OA with pain for at least 6 months, despite conservative treatment such as analgesics, NSAIDs and/or physical therapy * average pain on knee movement of 30 mm or greater on a 100-mm VAS * grade 2 or 3 knee OA according to the Kellgren-Lawrence grading system based on radiographs taken within the previous 6 months * Radiological evidence of bilateral knee OA was accepted if global pain VAS in the contralateral knee was less than 30 mm.
Exclusion criteria
* previous orthopedic surgery on the spine or lower limbs * disabling OA of either hip or foot * knee instability, clinical apparent joint effusion or marked valgus/varus deformity * known allergy to avian proteins or HA products * women ascertained or suspected pregnancy or lactating * intraarticular injections within the past 6 months * infections or skin diseases around the target knee * any specific medical conditions (rheumatoid arthritis, hemiparesis, neoplasm, etc.) that would interfere with the assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS pain score | at 1, 3 and 6 months postinjection | the change from baseline in the VAS pain score over 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up-and-Go test (TUG) | at 1, 3 and 6 months postinjection | 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 |
| Single-leg stance test (SLS) | at 1, 3 and 6 months postinjection | 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. |
| Lequesne index | at 1, 3 and 6 months postinjection | Maximal score is 24 and higher scores represent worse function. |
| satisfaction based on a 100 mm VAS | at 1, 3 and 6 months postinjection | Patients were asked to rate their treatment satisfaction compared to the preinjection condition, based on a 100 mm VAS |
| The reported adverse events | at 1 week (safety records via phone call), 1, 3 and 6 months after the injection | 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 |
| WOMAC, Likert Scale | at 1, 3 and 6 months postinjection | a 24-item questionnaire with 3 subscales measuring pain, stiffness, and physical function. Total score is 96 and lower scores indicate better outcomes. |
Countries
Taiwan
Outcome results
None listed