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

University of Sao Paulo General Hospital1 site in 1 country108 target enrollmentMarch 2011

ConditionsOsteoarthritis

InterventionsHylan GF-20 alone Triamcinolone

DrugsHylan GF-20 alone Triamcinolone

Overview

Phase: Phase 4
Intervention: Hylan GF-20 alone
Conditions: Osteoarthritis
Sponsor: University of Sao Paulo General Hospital
Enrollment: 108
Locations: 1
Primary Endpoint: Results in WOMAC, Lequesne and VAS scores
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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).

Registry

clinicaltrials.gov

Start Date

March 2011

End Date

July 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Sao Paulo General Hospital

Responsible Party

Principal Investigator

Marcia Uchoa Rezende

MD, PhD

University of Sao Paulo General Hospital

Eligibility 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

Arms & Interventions

Hylan GF-20 alone

This arm will receive a knee infiltration with 6ml of Hylan GF-20 only

Intervention: Hylan GF-20 alone

Triamcinolone

This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone

Intervention: Triamcinolone

Outcomes

Primary Outcomes

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.