Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

December 22, 2014 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Prospective And Randomized Study Evaluating Tthe Effect Of The Association Of Triamcinolone To The Viscosupplementation Of The Knee

The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

So far there is no convincing evidence that any treatment can be really effective in slowing or preventing the development of OA. The viscosupplementation by intraarticular injection of hyaluronate-derived products has gained popularity as a treatment modality of gonarthrosis. Today there are various papers on the treatment of gonarthrosis by intraarticular injection. Several methods have shown good results. There isn't, however, a consensus on the best method. The investigators know that in the treatment of osteoarthritis, with the viscosupplementation Hylan is superior in the long term, than the infiltration with cortisone. The good short term results achieved by infiltration of cortisone make us think about the combination of these drugs. The investigators will be assessing 104 patients with osteoarthritis of the knee, divided into two groups. Patients in group 1 will be subjected to infiltration procedure 6ml of Hylan. Patients in Group 2 will undergo the procedure of infiltration with 6ml of Hylan and 1ml (20mg) of hexacetonide Triamcinolone. The researcher will apply the informed consent term, the pain visual analog scale (VAS), WOMAC and Lequesne questionnaires. The questionnaires will be answered before infiltration (week zero), one week after the puncture (week 1), four weeks after (week 4) and 12 weeks after (week 12) and 24 weeks after (week 24).

Study Type

Interventional

Enrollment (Actual)

108

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

  • Brazil
      • São Paulo, Brazil, 05403-010
        • Instituto de Ortopedia E Traumatologia Do Hospital Das Clinicas Da Universidade de Sao Paulo

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

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age between 45 and 80 years
  • Osteoarthritis Diagnosis with radiographic evidence
  • absence of previous intraarticular knee fracture
  • absence of allergy to Synvisc or Triancil

Exclusion Criteria:

  • Development of Pioarthritis
  • Failure to attend to the consultations

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hylan GF-20 alone
This arm will receive a knee infiltration with 6ml of Hylan GF-20 only
Drug: Hylan GF-20 alone
A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)
Other Names:
  • Synvisc One
Experimental: Triamcinolone
This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone
Drug: Triamcinolone
A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)
Other Names:
  • Synvisc One and Triancil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results in WOMAC, Lequesne and VAS scores
Time Frame: 4 weeks
The outcome will be measured with the WOMAC and LEQUESNE scores, both about quality of life and knee function. The subjects will also use the VAS (VISUAL ANALOGIC SCALE) of pain. The results will be compared between the two groups within 1 week and 4 weeks after the viscosupplementation.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Results in WOMAC, Lequesne and VAS scores after 24 weeks
Time Frame: 24 weeks
The investigators are also going to compare the results after 24 weeks
24 weeks

Collaborators and Investigators

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

Sponsor

University of Sao Paulo General Hospital

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Study Chair: Olavo Pires de Camargo, Prof. Dr., Faculdade de Medicina da Universidade de Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 13, 2011

First Posted (Estimate)

April 14, 2011

Study Record Updates

Last Update Posted (Estimate)

December 23, 2014

Last Update Submitted That Met QC Criteria

December 22, 2014

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010/11450-9

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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