Clinical trial NCT03090698: Outcomes of Injections in Patients Waiting for Total Knee Replacement
Official title: Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis
knee
treatment
Lead sponsor: Universidade Federal Fluminense
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lysholm M1
timeFrame: One month
measure: KSS M1
timeFrame: One month
Secondary outcomes:
measure: Lysholm M3
timeFrame: Three months
measure: KSS M3
timeFrame: Three months
measure: Lysholm M6
timeFrame: Six months
measure: KSS M6
timeFrame: Six months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital dos Servidores do Estado do Rio de Janeiro
Study officials:
affiliation: Hospital dos Servidores do Estado
name: Andre Campos
role: PRINCIPAL_INVESTIGATOR
References: