The Efficacy and Safety of Intraarticular Sodium Hyaluronate (Hyalgan) After Proximal Tibial Osteotomy in Treatment of Knee Osteoarthritis Patients

NCT01267214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-11-21

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy and safety of Hyalgan after proximal tibial osteotomy in treatment of knee osteoarthritis patients. Normally, OA patients who were treated with osteotomy will not be treated with any SYSADOA after operation, even though their cartilage's not completely loss, so osteotomy plus HA injection should provide more benefit to patients than osteotomy alone.

Conditions

Interventions

DRUG

Sodium Hyaluronate (Hyalgan)

1% Sodium Hyaluronate in prefilled syringe

PROCEDURE

Osteotomy alone

no injection

Sponsors & Collaborators

  • TRB Chemedica

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2010-02-28
Completion
2011-07-31

Countries

  • Thailand

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 NCT01267214 on ClinicalTrials.gov