Efficacy of Three Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Function in Patients With Knee Osteoarthritis (OA)

Osteoarthritis Clinical Trial

Official title: Efficacy of 3 Weekly Injections of a Bacterial-- Sourced Hyaluronate on Pain and Physical Function in Patients With Knee Osteoarthritis—a Randomized Controlled Clinical Trial

Status Completed

Clinical Trial Summary

Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with knee osteoarthritis. The treatment effects can last for 6 months.

Clinical Trial Description

Background: Viscosupplementation with intra-articular hyaluronate injections is a safe and effective treatment of knee osteoarthritis. There are several forms of hyaluronate with different origin, method of production, molecular weight, dosing instructions and possibly clinical outcomes. Most current hyaluronate products are avian in origin, and only few are bioengineered via bacterial fermentation. The purpose of this study was to evaluate the efficacy and safety of 3 weekly injections of a bacterial-sourced hyaluronate (Hya-Joint) in patients with knee osteoarthritis.

Methods: As a prospective randomized observer-blind study done in a university-affiliated tertiary care medical center, patients with knee osteoarthritis for at least 6 months were enrolled. Eligible patients were randomized to receive three weekly intraarticular injections of either bacterial-sourced hyaluronate (Hya-Joint) or avian-derived hyaluronate (Hyalgan) into the target knee. The primary outcome was the visual analog scale (VAS) change from baseline for knee pain at 6-month follow-up. Secondary outcome measures included Lequesne index, timed up and go test (TUG), patients' global satisfaction and analgesics consumption.

Results: A total of 95 participants were randomly assigned and 89 participants completed the study. Both groups had significant improvements in pain as early as 1 and 2 weeks after the first injection, and the pain-reduction effects could last for 6 months, with no between-group differences. The Lequesne index scores and results of TUG tests improved significantly from baseline in both group at all follow-up visits (p<0.001 for each test compared with baseline), with no significant between-group differences at 1-month and 6-month follow-up. However, significantly greater improvements favoring the Hya-Joint group were noted at 3-month follow-up (p<0.05). No between-group differences were seen regarding the use of analgesics. Both groups reported high satisfaction at 6-month follow-up. No serious adverse events occurred.

Conclusions: Three weekly injections of hyaluronate (Hya-Joint) are safe and well tolerated, provide rapid pain relief as early as 1 and 2 weeks after the first injection, and improve function in patients with knee osteoarthritis. The treatment effects can last for 6 months. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyaluronate
• Knee
• Osteoarthritis
• Osteoarthritis, Knee

• NCT number: NCT01185444
• Study type: Interventional
• Source: Kaohsiung Veterans General Hospital.
• Status: Completed
• Phase: Phase 2
• Start date: February 2009
• Completion date: December 2009