Outcomes of Injections in Patients Waiting for Total Knee Replacement

March 20, 2017 updated by: Vinicius Schott Gameiro, Universidade Federal Fluminense

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 20.221-903
        • Recruiting
        • Hospital dos Servidores do Estado do Rio de Janeiro
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Hylan
Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
Drug: Hylan G-F 20
intra-articular administration
ACTIVE_COMPARATOR: Hylan + Corticosteroid
Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
Drug: Hylan G-F 20
intra-articular administration
Drug: Triamcinolone
Intra-articular administration
ACTIVE_COMPARATOR: Corticosteroid
Intra-articular (knee) 1ml Triamcinolone administration (single shot)
Drug: Triamcinolone
Intra-articular administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm M1
Time Frame: 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.
One month
KSS M1
Time Frame: 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.
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysholm M3
Time Frame: 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.
Three months
KSS M3
Time Frame: 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.
Three months
Lysholm M6
Time Frame: 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.
Six months
KSS M6
Time Frame: 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.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal Fluminense

Investigators

  • Principal Investigator: Andre Campos, Hospital dos Servidores do Estado

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

June 1, 2017

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (ACTUAL)

March 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 20, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VISCO KNEE UFF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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