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Outcomes of Injections in Patients Waiting for Total Knee Replacement

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ClinicalTrials.gov Identifier: NCT03090698
Recruitment Status : Unknown
Verified March 2017 by Vinicius Schott Gameiro, Universidade Federal Fluminense.
Recruitment status was:  Recruiting
First Posted : March 27, 2017
Last Update Posted : March 27, 2017
Sponsor:
Information provided by (Responsible Party):
Vinicius Schott Gameiro, 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: Hylan G-F 20 Drug: Triamcinolone Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Viscosupplementation in Patients With Severe Osteoarthritis of the Knee
Actual Study Start Date : September 2015
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03090698


Contacts
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Contact: Andre Campos +55 21 22913131 ext 3374 andresiqueiracampos@hotmail.com
Contact: Vinicius Gameiro drschott@bol.com.br

Locations
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Brazil
Hospital dos Servidores do Estado do Rio de Janeiro Recruiting
Rio de Janeiro, Brazil, 20.221-903
Contact: Andre Campos    +55 21 22913131 ext 3374    andresiqueiracampos@hotmail.com   
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
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Principal Investigator: Andre Campos Hospital dos Servidores do Estado

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Responsible Party: Vinicius Schott Gameiro, Clinical Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT03090698     History of Changes
Other Study ID Numbers: VISCO KNEE UFF
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: March 27, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Vinicius Schott Gameiro, Universidade Federal Fluminense:
osteoarthritis
knee
treatment
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Hylan
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Viscosupplements
Protective Agents