Outcomes of Injections in Patients Waiting for Total Knee Replacement

Osteoarthritis of the Knee Clinical Trial

Official title:

Viscosupplementation in Patients With Severe Osteoarthritis of the Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03090698
• Other study ID #: VISCO KNEE UFF
• Status: Recruiting
• Phase: Phase 4
• First received: March 2, 2017
• Last updated: March 20, 2017
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: March 2017
• Source: Universidade Federal Fluminense
• Contact: Andre Campos
• Phone: +55 21 22913131
• Email: andresiqueiracampos[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• Hylan G-F 20
intra-articular administration
• Triamcinolone
Intra-articular administration

Locations

Country	Name	City	State
Brazil	Hospital dos Servidores do Estado do Rio de Janeiro	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal Fluminense

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lysholm M1	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.	One month
Primary	KSS M1	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.	One month
Secondary	Lysholm M3	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.	Three months
Secondary	KSS M3	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.	Three months
Secondary	Lysholm M6	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.	Six months
Secondary	KSS M6	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.	Six months