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

NCT02686047 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2016-02-19

No results posted yet for this study

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.

Conditions

Interventions

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).

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02686047 on ClinicalTrials.gov