Comparing Efficacy and Safety of a Single Intraarticular Injection of a Novel Crosslinked Hyaluronic Acid (HYAJOINT Plus) With Synvisc-One for the Treatment of Knee Osteoarthritis: A Randomized-Controlled, Double-Blind Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Kaohsiung Veterans General Hospital.
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- VAS pain score
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Shu-Fen Sun
MD
Kaohsiung Veterans General Hospital.
Eligibility Criteria
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
Outcomes
Primary Outcomes
VAS pain score
Time Frame: at 1, 3 and 6 months postinjection
the change from baseline in the VAS pain score over 6 months.
Secondary Outcomes
- WOMAC, Likert Scale(at 1, 3 and 6 months postinjection)
- Lequesne index(at 1, 3 and 6 months postinjection)
- Timed Up-and-Go test (TUG)(at 1, 3 and 6 months postinjection)
- Single-leg stance test (SLS)(at 1, 3 and 6 months postinjection)
- satisfaction based on a 100 mm VAS(at 1, 3 and 6 months postinjection)
- The reported adverse events(at 1 week (safety records via phone call), 1, 3 and 6 months after the injection)