Osteoarthritis of the Knee Clinical Trial
Official title:
Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
A comparison of intraarticular administration of Hylan GF20, Triamcinolone and both associated in patients with severe osteoarthritis of the knee with follow up of one, three and six months.
The objective of this research is to evaluate the short-term results of viscosupplementation
in patients with advanced osteoarthritis of the knee.
There is a bigger demand of patients requiring total knee arthroplasty than the number of
surgeries performed by the Unified Health System in Brazil. For this reason the queues to
perform this surgery are huge and time-consuming in the referral hospitals. Whereas all
these patients are suffering from severe pain and limiting, and awaiting the surgery for a
few years, it is necessary to try any treatment, even if temporary, to ease the pain and
suffering of those patients.
A double-blind randomized prospective study will be held at Hospital Federal dos Servidores
do Estado do Rio de Janeiro, with patients from the waiting list for Total Knee Arthroplasty
who accept to participate and sign the informed consent form. Will be selected the last 150
knees in TKA queue. Patients will be randomized and divided in 3 groups of 50 knees. A group
will be submitted to an intraarticular injection of corticosteroid (1 ml of sterile
Triamcinolone Hexacetonide solution 20 mg/ml). A second group will be subjected to
administration of 6 ml of Hylan GF20. The third group will receive Hylan GF20 associated
with corticosteroid (7 ml solution containing 1 ml of triamcinolone and 6 ml of Hylan GF20).
The injection technique will be the same for all patients. The outcome results will be
measured by a form with patient data, functional scores (Knee Society Score and Lysholm)
before treatment and at one, three and six months after treatment.
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