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Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01335321
First Posted: April 14, 2011
Last Update Posted: December 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Marcia Uchoa Rezende, University of Sao Paulo General Hospital
  Purpose
The purpose of this study is to evaluate if the investigators can achieve better early outcomes adding triamcinolone to the viscosupplementation procedure.

Condition Intervention Phase
Osteoarthritis Drug: Hylan GF-20 alone Drug: Triamcinolone Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Prospective And Randomized Study Evaluating Tthe Effect Of The Association Of Triamcinolone To The Viscosupplementation Of The Knee

Resource links provided by NLM:


Further study details as provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 108
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Synvisc One and Triancil

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).
  Eligibility

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01335321


Locations
Brazil
Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo
São Paulo, Brazil, 05403-010
Sponsors and Collaborators
University of Sao Paulo General Hospital
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 São Paulo
  More Information

Publications:

Responsible Party: Marcia Uchoa Rezende, MD, PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01335321     History of Changes
Other Study ID Numbers: 2010/11450-9
First Submitted: April 12, 2011
First Posted: April 14, 2011
Last Update Posted: December 23, 2014
Last Verified: March 2011

Keywords provided by Marcia Uchoa Rezende, University of Sao Paulo General Hospital:
viscosupplementation
intra-articular injection
hyaluronic acid
osteoarthritis
knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Hylan
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Viscosupplements
Protective Agents