Autor: |
Richard L Rauck, Eric Loudermilk, Simon J Thomson, Jose Francisco Paz-Solis, Louis Bojrab, John Noles, Jan Vesper, Joseph Atallah, Daniel Roth, Joseph Hegarty, Michel Prud'Homme, Gregory M Phillips, Stephen G Smith, Mohab Ibrahim, Channing D Willoughby, Jon B Obray, Mayank Gupta, Julio Paez, Anthony P Berg, Nathan J Harrison, Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love-Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor-Aryeh, Marc A Russo, Nicolas Varela, Jeffrey B Phelps, José Cid, Tacson Fernandez, Concepción Pérez-Hernández, Douglas Keehn, Joshua M Rosenow, Nameer Haider, Andrew G Parrent, Melinda M Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, Reinhard Thoma, Atef F Israel, Giuliano De Carolis, Sanjay Bhatia, Matthew Green, Armando Villarreal, Matthew T Crooks, Ryder P Gwinn, Julie G Pilitsis, Hitoaki Sato, Sergio Maldonado Vega, M. Gabriel Hillegass, Paul Carnes, Christian Scherer, Silviu Brill, James Yu, James J Brennan, Kliment Gatzinsky, Annu Navani, Lee T Snook Jr, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew T Trobridge, Kamyar Assil, Jawad Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, Rene Przkora, Norihiko Sukenaga, Louis J Raso, Aaron K Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan-Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D Candido, Tristan E Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain |
Rok vydání: |
2023 |
Předmět: |
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Zdroj: |
Pain Management. 13:115-127 |
ISSN: |
1758-1877 1758-1869 |
DOI: |
10.2217/pmt-2022-0091 |
Popis: |
Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event ( Clinical Trial Registration: NCT01719055 ( ClinicalTrials.gov ) |
Databáze: |
OpenAIRE |
Externí odkaz: |
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