Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.
Pain Manag
; 13(2): 115-127, 2023 Feb.
Article
en En
| MEDLINE
| ID: mdl-36691862
ABSTRACT
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 (<1%).Conclusion:
This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration NCT01719055 (ClinicalTrials.gov).Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Dolor Crónico
/
Estimulación de la Médula Espinal
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
Límite:
Humans
Idioma:
En
Revista:
Pain Manag
Año:
2023
Tipo del documento:
Article
País de afiliación:
Estados Unidos