Outcomes of Injections in Patients Waiting for Total Knee Replacement

Phase 4

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: Hylan G-F 20; Drug: Triamcinolone

• Registration Number: NCT03090698
• Lead Sponsor: Universidade Federal Fluminense

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.

Study Timeline

• Study Start: 2015-09
• Status Verified: 2017-03
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-20
• Last Update Submitted: 2017-03-20
• Study First Posted: 2017-03-27
• Last Update Posted: 2017-03-27
• Primary Completion: 2017-04
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hylan + Corticosteroid	Hylan G-F 20	Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
Corticosteroid	Triamcinolone	Intra-articular (knee) 1ml Triamcinolone administration (single shot)
Hylan	Hylan G-F 20	Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
Hylan + Corticosteroid	Triamcinolone	Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)

Primary Outcome Measures

Name	Time	Method
Lysholm M1	One month	The outcome will be measured by Lysholm Score within one month. The results will be compared within each group from baseline and between the 3 groups.
KSS M1	One month	The outcome will be measured by Knee Society Score within one month. The results will be compared within each group from baseline and between the 3 groups.

Secondary Outcome Measures

Name	Time	Method
Lysholm M3	Three months	The outcome will be measured by Lysholm Score within three months. The results will be compared within each group from baseline and between the 3 groups.
KSS M3	Three months	The outcome will be measured by Knee Society Score within three months. The results will be compared within each group from baseline and between the 3 groups.
Lysholm M6	Six months	The outcome will be measured by Lysholm Score within six months. The results will be compared within each group from baseline and between the 3 groups.
KSS M6	Six months	The outcome will be measured by Knee Society Score within six months. The results will be compared within each group from baseline and between the 3 groups.

Trial Locations

Locations (1)

Hospital dos Servidores do Estado do Rio de Janeiro; 🇧🇷 Rio de Janeiro, Brazil