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Completed

NCT Number: NCT01335321

Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

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

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo

São Paulo, 05403-010, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hylan GF-20 alone

Drug

A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)

Other names: Synvisc One

Triamcinolone

Drug

A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)

Other names: Synvisc One and Triancil

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Collaborators

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Apr 14, 2011
Registry last updated
Dec 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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