NCT02686047

Comparing One Intraarticular Injection of a Novel HYAJOINT Plus With Synvisc-One for the Treatment of Knee OA

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Kaohsiung Veterans General Hospital. · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	HYAJOINT Plus	The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
DEVICE	Synvisc-One	The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2016-02-19
• Last updated: 2016-02-19

Locations

1 site across 1 country: Taiwan