NCT03643588

The Comparison of HYAJOINT Plus and Hyalgan Hyaluronan Supplement for Knee Osteoarthritis Pain

Safety and Effectiveness of HYAJOINT Plus Synovial Fluid Supplement for the Treatment of Knee Osteoarthritis Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: SciVision Biotech Inc. · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
DEVICE	HYAJOINT Plus	Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
DEVICE	Hyalgan	Three-injection, 20 mg / 2 ml (1%) linear hyaluronan

Timeline

• Start date: 2015-09-04
• Primary completion: 2016-09-19
• Completion: 2017-04-12
• First posted: 2018-08-23
• Last updated: 2018-08-24