Back to Search
Start Over
Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.
- Source :
-
Pain management [Pain Manag] 2023 Feb; Vol. 13 (2), pp. 115-127. Date of Electronic Publication: 2023 Jan 24. - Publication Year :
- 2023
-
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).
Details
- Language :
- English
- ISSN :
- 1758-1877
- Volume :
- 13
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Pain management
- Publication Type :
- Academic Journal
- Accession number :
- 36691862
- Full Text :
- https://doi.org/10.2217/pmt-2022-0091