Outcomes of Injections in Patients Waiting for Total Knee Replacement

Universidade Federal Fluminense

Status and phase: Unknown; Phase 4

Conditions: Osteoarthritis of the Knee

Treatments: Drug: Hylan G-F 20; Drug: Triamcinolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03090698

VISCO KNEE UFF

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Over 18 years old;
• Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
• Acceptance and signature of the TFCC;

Exclusion criteria

• Infiltration of the knee for the past 6 months;
• Allergic to any substance used in the study;
• Prior infection in the knee.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 3 patient groups

Hylan

Active Comparator group

Description:

Intra-articular (knee) 6ml Hylan GF20 administration (single shot)

Treatment:

Drug: Hylan G-F 20

Hylan + Corticosteroid

Active Comparator group

Description:

Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)

Treatment:

Drug: Hylan G-F 20

Drug: Triamcinolone

Corticosteroid

Active Comparator group

Description:

Intra-articular (knee) 1ml Triamcinolone administration (single shot)

Treatment:

Drug: Triamcinolone