Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee

April 21, 2014 updated by: Phonthakorn Panichkul, Thammasat University

Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee: A Prospective, Double-blind Randomized Controlled Trial

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Corticosteroid and Hylan G-F 20 are both effective in improving pain and function of osteoarthritic knee patients up to 6 months.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Prathumthani, Thailand, 12121
        • Thammasat University Hospital, Thammasat University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of knee OA
  • Knee pain for most days of the prior month
  • Radiographic evidence consistent with knee OA
  • Aged between 40 and 80 years old

Exclusion Criteria:

  • Lumbar spondylosis
  • Gross deformity of the knee
  • Co-existent inflammatory or crystal arthritis
  • Prior knee surgery
  • Injury to the knee in the preceding 6 months
  • Any intra-articular injection in the preceding 3 months
  • Pregnant or Lactating
  • Current infection in the affected knee
  • Inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single shot Hylan G-F 20 (Synvisc)
Intra-articular injection of the Single shot 6 mL of Hylan G-F 20 (Synvisc)
Drug: Hylan G-F 20
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Other Names:
  • Synvisc
Active Comparator: Corticosteroid (Triamcinolone acetonide)
Intra-articular injection of 1 mL of 40 mg Triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline injected at the knee by single shot
Drug: Corticosteroid
After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
Other Names:
  • Triamcinolone acetonide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Score
Time Frame: 6 months
Change from Baseline in WOMAC score at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale(VAS)
Time Frame: 6 months
Change from Baseline in VAS score at 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Study Director: Nattapol Tammachote, MD, MSc, Department of Orthopaedics, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2014

Last Update Submitted That Met QC Criteria

April 21, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OrthoTU-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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