Outcomes of Injections in Patients Waiting for Total Knee Replacement
NCT ID: NCT03090698
Last Updated: 2017-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2015-09-30
2017-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of the Effect of Adding Corticosteroid to Viscosupplementation
NCT01335321
Intra-articular Corticosteroid Injection Compared With Single-Shot Hyaluronic Acid for Treatment of Osteoarthritis Knee
NCT01874574
Gait Patterns After Intraarticular Treatment of Patients With Osteoarthritis of the Knee
NCT00731289
Hip Viscosupplementation: What is the Best Dosage?
NCT01810809
Knee Injection RCT
NCT03694821
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Hylan
Intra-articular (knee) 6ml Hylan GF20 administration (single shot)
Hylan G-F 20
intra-articular administration
Hylan + Corticosteroid
Intra-articular (knee) 6ml Hylan GF20 and 1ml Triamcinolone 20mg/ml administration (single shot)
Hylan G-F 20
intra-articular administration
Triamcinolone
Intra-articular administration
Corticosteroid
Intra-articular (knee) 1ml Triamcinolone administration (single shot)
Triamcinolone
Intra-articular administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Hylan G-F 20
intra-articular administration
Triamcinolone
Intra-articular administration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Waiting for Total Knee Arthroplasty (at Hospital Federal dos Servidores queue);
* Acceptance and signature of the TFCC;
Exclusion Criteria
* Allergic to any substance used in the study;
* Prior infection in the knee.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidade Federal Fluminense
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vinicius Schott Gameiro
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andre Campos
Role: PRINCIPAL_INVESTIGATOR
Hospital dos Servidores do Estado
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital dos Servidores do Estado do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VISCO KNEE UFF
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.