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GAUCHO - Trial Genicular Artery Embolization Using Imipenem/Cilastatin vs. Microsphere for Knee Osteoarthritis: A Randomized Controlled Trial

  • Study Protocol
  • Embolisation (arterial)
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Abstract

Genicular artery embolization (GAE) has emerged as a treatment option to improve quality of life in patients suffering from moderate-to-severe pain refractory to conservative treatment of knee osteoarthritis, with encouraging results. This paper describes the study protocol of a single-center, double-blind, randomized controlled trial designed to evaluate and compare the safety and efficacy of GAE using imipenem/cilastatin vs. microspheres for the treatment of moderate-to-severe pain associated with knee osteoarthritis. We hypothesized that there will be no difference in safety and efficacy outcomes. The study received ethics approval of the institutional review board with number 4.364.391 / CAAE: 37590820.3.0000.5342 and is registered onto the Registro Brasileiro de Ensaios Clinicos (ReBEC), with number RBR-2h5rwgb. Technical success was defined as embolization of at least 1 feeding artery supplying the hyperemic synovium of the knee joint. Primary outcome: clinical success was defined as improvement in symptoms, 50% reduction in Western Ontario and McMaster Universities Osteoarthritis Index pain scores or an increase of at least 10 points in the Knee Injury and Osteoarthritis Outcome Score from baseline to 3 months of follow-up. Secondary outcome: radiological success was defined as significant improvement in the Whole-Organ Magnetic Resonance Imaging Score for knee synovitis considering the embolized areas at 12 months of follow-up after GAE and a reduction in the analgesia or other conservative therapies for knee pain used by the patient at 3 and 12 months of follow-up. Clinical assessments will be performed before GAE, during GAE and at hospital discharge (for Visual Analog Scale of pain), and at 30 days, 3 months, and 12 months after GAE.

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Acknowledgements

The authors like to acknowledge the medical teams and institutions supporting this study: Invasc, Hospital Ortopédico, Hospital de Clínicas de Passo Fundo, Clinica Cedil, Imed e Universidade de Passo Fundo.

Funding

Merit Medical has partially funded this trial. Contact of Merit Brasil +55 11 51024368. This sponsor has only funded the introducers, catheters, microcatheters, guide wires and the microspheres. No fee is been paid for researchers. The sponsor has no other contribution to this study.

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Authors and Affiliations

  1. Instituto Vascular de Passo Fundo (Invasc), R. Capitão Araújo 297/1207, Passo Fundo, RS, 99010-200, Brazil

    Mateus Picada Correa

  2. Universidade de Passo Fundo (UPF), R. Uruguai, 2001/414B, Passo Fundo, RS, 99010-112, Brazil

    Mateus Picada Correa & Ricardo Lugokeski

  3. Universidade Meridional (Imed), R. Gen Prestes Guimarães, 304, Passo Fundo, RS, 999070-220, Brazil

    Mateus Picada Correa

  4. Instituto do Câncer do Estado de São Paulo, School of Medicine, Universidade de São Paulo (USP), Av. Dr. Arnaldo, 251, Cerqueira Cesar, São Paulo, SP, 01246-000, Brazil

    Joaquim M. Motta-Leal-Filho

  5. Instituto do Coração (InCor), School of Medicine, Universidade de São Paulo (USP), Av. Dr. Enéas de Carvalho Aguiar, 44, São Paulo, SP, 05403-900, Brazil

    Joaquim M. Motta-Leal-Filho

  6. Hospital Ortopédico de Passo Fundo. Av, 7 de Setembro, 817, Passo Fundo, RS, 99010-121, Brazil

    Marcio Mezzomo & Lucas Ricci Leite

  7. Clínica Cedil, Av. 7 de Setembro, 817, Passo Fundo, RS, 99010-121, Brazil

    Ricardo Lugokeski

Authors
  1. Mateus Picada Correa
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  2. Joaquim M. Motta-Leal-Filho
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  3. Ricardo Lugokeski
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  4. Marcio Mezzomo
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  5. Lucas Ricci Leite
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Contributions

MPC involved in concept of the trial. JMMLF and MPC involved in design of the trial. MPC and JMMLF involved in written the study protocol. MPC, JMMLF, RL, MM and LRL involved in critical review of the study protocol. MPC, JMMLF, RL, MM and LRL involved in written and performed critical review of the paper. MPC involved in overall responsibility.

Corresponding author

Correspondence to Mateus Picada Correa.

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Conflict of interest

The authors declare that they have no conflict of interest.

Consent for Publication

Written informed consent not applicable for this publication.

Ethical Approval

This is a study protocol for a Randomized controlled trial. Informed Consent was created and approved at the University of Passo Fundo ethical committee. Protocol number: 4.364.391 / CAAE: 37590820.3.0000.5342. The trial was approved on Brazilian Registry of Clinical Trials (ReBEC) by the number RBR-2h5rwgb. This is the first version of the protocol. The Data Monitoring Committee is the ethical committee of University of Passo Fundo. Any adverse events will be reported to the committee and analyzed.

Ethical Committee

GAUCHO trial is approved in the Ethic Committee of University of Passo Fundo with number 4.364.391 / CAAE: 37590820.3.0000.5342 and, registered onto the Registro Brasileiro de Ensaios Clínicos (ReBEC), with number RBR-2h5rwgb.

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Correa, M.P., Motta-Leal-Filho, J.M., Lugokeski, R. et al. GAUCHO - Trial Genicular Artery Embolization Using Imipenem/Cilastatin vs. Microsphere for Knee Osteoarthritis: A Randomized Controlled Trial. Cardiovasc Intervent Radiol 45, 903–910 (2022). https://doi.org/10.1007/s00270-022-03089-z

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  • DOI: https://doi.org/10.1007/s00270-022-03089-z

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