Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

Phase 4

Completed

• Conditions: Osteoarthritis
• Interventions: Drug: Hylan GF-20 alone; Drug: Triamcinolone

• Registration Number: NCT01335321
• Lead Sponsor: University of Sao Paulo General Hospital

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).

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-03
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Primary Completion: 2011-11
• Study Completion: 2012-07
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hylan GF-20 alone	Hylan GF-20 alone	This arm will receive a knee infiltration with 6ml of Hylan GF-20 only
Triamcinolone	Triamcinolone	This arm will receive a knee infiltration with 6ml of Hylan GF-20 associated with 1ml of triamcinolone

Primary Outcome Measures

Name	Time	Method
Results in WOMAC, Lequesne and VAS scores	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

Name	Time	Method
Results in WOMAC, Lequesne and VAS scores after 24 weeks	24 weeks	The investigators are also going to compare the results after 24 weeks

Trial Locations

Locations (1)

Instituto de Ortopedia e Traumatologia do Hospital das Clínicas da Universidade de São Paulo; 🇧🇷 São Paulo, Brazil