Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation

University of Sao Paulo General Hospital

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis

Treatments: Drug: Hylan GF-20 alone; Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT01335321

2010/11450-9

Details and patient eligibility

About

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

Full 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).

Enrollment: 108 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups

Hylan GF-20 alone

Active Comparator group

Description:

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

Treatment:

Drug: Hylan GF-20 alone

Triamcinolone

Experimental group

Description:

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

Treatment:

Drug: Triamcinolone