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

NCT01185444 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2010-08-20

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Hya-Joint

The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.

PROCEDURE

Hyalgan

The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.

Sponsors & Collaborators

  • Kaohsiung Veterans General Hospital.

    lead OTHER

Principal Investigators

  • Shu-Fen Sun, MD · Veterans General Hospital, Kaohsiung;National Yang-Ming University School of Medicine, Taiwan

  • Chien-Wei Hsu, MD · Department of Internal Medicine, Kaohsiung Veterans General Hospital

  • Hsien-Pin Sun, MD · Cheng Ching Hospital, Taiwan

  • Hung-Ju Li, MS · Institute of Statistics, National University of Kaohsiung, Taiwan

  • Jue-Long Wang, MD · Kaohsiung Veterans General Hospital, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

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 NCT01185444 on ClinicalTrials.gov