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Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/1264
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dc.contributor.authorRauck RLen_US
dc.contributor.authorLoudermilk Een_US
dc.contributor.authorThomson SJen_US
dc.contributor.authorPaz-Solis JFen_US
dc.contributor.authorBojrab Len_US
dc.contributor.authorNoles Jen_US
dc.contributor.authorVesper Jen_US
dc.contributor.authorAtallah Jen_US
dc.contributor.authorRoth Den_US
dc.contributor.authorHegarty Jen_US
dc.contributor.authorPrud'Homme Men_US
dc.contributor.authorPhillips GMen_US
dc.contributor.authorSmith SGen_US
dc.contributor.authorIbrahim Men_US
dc.contributor.authorWilloughby CDen_US
dc.contributor.authorObray JBen_US
dc.contributor.authorGupta Men_US
dc.contributor.authorPaez Jen_US
dc.contributor.authorBerg APen_US
dc.contributor.authorHarrison NJen_US
dc.contributor.authorMaino Pen_US
dc.contributor.authorMambalam Pen_US
dc.contributor.authorMcCarty Men_US
dc.contributor.authorTowlerton Gen_US
dc.contributor.authorLove-Jones Sen_US
dc.contributor.authorAhmed Sen_US
dc.contributor.authorLee Aen_US
dc.contributor.authorShah Ben_US
dc.contributor.authorGoor-Aryeh Ien_US
dc.contributor.authorRusso Men_US
dc.contributor.authorVarela Nen_US
dc.contributor.authorPhelps JBen_US
dc.contributor.authorCid Jen_US
dc.contributor.authorFernandez Ten_US
dc.contributor.authorPérez-Hernández Cen_US
dc.contributor.authorKeehn Den_US
dc.contributor.authorRosenow JMen_US
dc.contributor.authorHaider Nen_US
dc.contributor.authorParrent AGen_US
dc.contributor.authorLawrence MMen_US
dc.contributor.authorGeorgius Pen_US
dc.contributor.authorDemartini Len_US
dc.contributor.authorMendiola Aen_US
dc.contributor.authorMehta Ven_US
dc.contributor.authorThoma Ren_US
dc.contributor.authorIsrael AFen_US
dc.contributor.authorCarolis Gen_US
dc.contributor.authorBhatia Sen_US
dc.contributor.authorGreen Men_US
dc.contributor.authorVillarreal Aen_US
dc.contributor.authorCrooks MTen_US
dc.contributor.authorGwinn RPen_US
dc.contributor.authorPilitsis JGen_US
dc.contributor.authorSato Hen_US
dc.contributor.authorVega SMen_US
dc.contributor.authorHillegass MGen_US
dc.contributor.authorCarnes Pen_US
dc.contributor.authorScherer Cen_US
dc.contributor.authorBrill Sen_US
dc.contributor.authorYu Jen_US
dc.contributor.authorBrennan JJen_US
dc.contributor.authorGatzinsky Ken_US
dc.contributor.authorNavani Aen_US
dc.contributor.authorSnook LT Jren_US
dc.contributor.authorBujedo BMen_US
dc.contributor.authorAndrés Ares Jen_US
dc.contributor.authorMurillo Aen_US
dc.contributor.authorTrobridge ATen_US
dc.contributor.authorAssil Ken_US
dc.contributor.authorShah Jen_US
dc.contributor.authorMcLeod Cen_US
dc.contributor.authorBuwembo Jen_US
dc.contributor.authorCoster Oen_US
dc.contributor.authorMiller Nen_US
dc.contributor.authorSanapati Men_US
dc.contributor.authorMikhael Men_US
dc.contributor.authorPrzkora Ren_US
dc.contributor.authorSukenaga Nen_US
dc.contributor.authorRaso LJen_US
dc.contributor.authorCalodney AKen_US
dc.contributor.authorCáceres Jerez LEen_US
dc.contributor.authorUchiyama Ten_US
dc.contributor.authorKallewaard JWen_US
dc.contributor.authorChandler Ben_US
dc.contributor.authorPiedimonte Fen_US
dc.contributor.authorCandido KDen_US
dc.contributor.authorWeaver TEen_US
dc.contributor.authorAgari Ten_US
dc.contributor.authorHolthouse Den_US
dc.contributor.authorWoon Ren_US
dc.contributor.authorPatel Nen_US
dc.contributor.authorLechleiter Ken_US
dc.contributor.authorJain Ren_US
dc.date2023-01-24-
dc.date.accessioned2025-01-10T04:47:04Z-
dc.date.available2025-01-10T04:47:04Z-
dc.date.issued2023-02-
dc.identifier.citation13(2):115-127.en_US
dc.identifier.issn1758-1869en_US
dc.identifier.urihttps://hdl.handle.net/11055/1264-
dc.description.abstractAim: 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).en_US
dc.subjectSCSen_US
dc.subjectreal-world evidenceen_US
dc.subjectregistryen_US
dc.subjectsafetyen_US
dc.subjectspinal cord stimulationen_US
dc.titleLong-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic painen_US
dc.typeJournal Articleen_US
dc.type.contentTexten_US
dc.identifier.journaltitlePain Managementen_US
dc.identifier.doi10.2217/pmt-2022-0091en_US
dc.description.affiliatesCarolinas Pain Institute & The Center for Clinical Research LLC, Winston-Salem, NC 27103, USA.en_US
dc.description.affiliatesPCPMG Clinical Research Unit LLC, Anderson, SC 29621, USA.en_US
dc.description.affiliatesMid & South Essex University Hospitals, Basildon, Essex, SS16 5NL, United Kingdom.en_US
dc.description.affiliatesUniversity Hospital La Paz, Madrid, 28046, Spain.en_US
dc.description.affiliatesForest Health Medical Center, Ypsilanti, MI 48198, USA.en_US
dc.description.affiliatesSpine & Pain Specialists, Shreveport, LA 71105, USA.en_US
dc.description.affiliatesUniversity Hospital Düsseldorf, Düsseldorf, 40225, Germany.en_US
dc.description.affiliatesThe Toledo Clinic, Toledo, OH 43606, USA.en_US
dc.description.affiliatesSummit Pain Management, Fort Wayne, IN 46804, USA.en_US
dc.description.affiliatesOptim Health System - Tattnall Hospital, Reidsville, GA 30453, USA.en_US
dc.description.affiliatesCHU de Québec - Université Laval, Quebec City, QC, G1L 3L5, Canada.en_US
dc.description.affiliatesPacific Sports & Spine, Eugene, OR 97401, USA.en_US
dc.description.affiliatesRamos Center for Interventional & Functional Pain Medicine, Englewood, FL 34205, USA.en_US
dc.description.affiliatesUniversity of Arizona, Banner Health - University Medical Center, Tucson, AZ 85719, USA.en_US
dc.description.affiliatesCarolina Orthopaedic & Neurological Associates, Greenville, SC 29615, USA.en_US
dc.description.affiliatesSouthwest Spine & Pain Center, St George, UT 84790, USA.en_US
dc.description.affiliatesKansas Pain Management & Neuroscience Research Center, LLC, Overland Park, KS 66210, USA.en_US
dc.description.affiliatesSouthlake Pain Institute, Clermont, FL 34711, USA.en_US
dc.description.affiliatesSpine Team Texas, Rockwall, TX 75032, USA.en_US
dc.description.affiliatesOchsner Health Center, Covington, LA 70433, USA.en_US
dc.description.affiliatesNeurocenter of Southern Switzerland, Ospedale Regionale di Lugano, Lugano, 6900, Switzerland.en_US
dc.description.affiliatesWashington Center for Pain Management, Bellevue, WA 98372, USA.en_US
dc.description.affiliatesBalcones Pain Consultants, Austin, TX 78749, USA.en_US
dc.description.affiliatesChelsea & Westminster Hospitals, London, SW10 9NH, United Kingdom.en_US
dc.description.affiliatesSouthmead Hospital, Bristol, BS10 5NB, United Kingdom.en_US
dc.description.affiliatesWeill Cornell Medicine, Center for Comprehensive Spine Care, New York City, NY 10022, USA.en_US
dc.description.affiliatesTallahassee Neurological Clinic, Tallahassee, FL 32308, USA.en_US
dc.description.affiliatesCarolinas Pain Center, Charlotte, NC 28262, USA.en_US
dc.description.affiliatesPain Medicine Institute, Sheba Medical Center, Ramat Gan, 52621, Israel.en_US
dc.description.affiliatesHunter Pain Specialists, Broadmeadow, New South Wales, 2292, Australia.en_US
dc.description.affiliatesClínica Universidad de Navarra, Pamplona, 31008, Spain.en_US
dc.description.affiliatesSpine Works Institute, North Richland Hills, TX 76182, USA.en_US
dc.description.affiliatesToledo University Hospital Complex, Toledo, 45004, Spain.en_US
dc.description.affiliatesRoyal National Orthopaedic Hospital, NHS Trust, Stanmore, Middlesex, HA7 4LP, United Kingdom.en_US
dc.description.affiliatesHospital Universitario de La Princesa, Madrid, 28006, Spain.en_US
dc.description.affiliatesPain Centers of Wisconsin, Fort Atkinson, WI 53220, USA.en_US
dc.description.affiliatesNorthwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.en_US
dc.description.affiliatesAPMR Spinal & Skeletal Pain Medicine, Utica, NY 13502, USA.en_US
dc.description.affiliatesLondon Health Sciences Centre, Western University, London, ON, N6A 5W9, Canada.en_US
dc.description.affiliatesCase Western Reserve University, Cleveland, OH 44106, USA.en_US
dc.description.affiliatesSunshine Coast Clinical Research, Noosa Heads, Queensland, 4567, Australia.en_US
dc.description.affiliatesFondazione Salvatore Maugeri IRCCS, Pavia, 27100, Italy.en_US
dc.description.affiliatesPuerta de Hierro University Hospital, Boadilla del Monte, 28222, Spain.en_US
dc.description.affiliatesSt. Bartholomew's Hospital, London, EC1A 7BE, United Kingdom.en_US
dc.description.affiliatesAlgesiologikum MVZ München, Munich, 80799, Germany.en_US
dc.description.affiliatesPain Management Associates, Lee's Summit, MO 64086, USA.en_US
dc.description.affiliatesSanta Chiara University Hospital, Pisa, 56126, Italy.en_US
dc.description.affiliatesWest Virginia University Neurosurgery, Morgantown, WV 26506, USA.en_US
dc.description.affiliatesPain Medicine of South Australia, Wayville, South Australia, 5034, Australia.en_US
dc.description.affiliatesUniversity of Rochester, Rochester, NY 14642, USA.en_US
dc.description.affiliatesPinnacle Pain & Spine, Scottsdale, AZ 85260, USA.en_US
dc.description.affiliatesEvergreenHealth Neurosurgery, Kirkland, WA 98034, USA.en_US
dc.description.affiliatesCharles E Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL 33431, USA.en_US
dc.description.affiliatesKobe University Hospital, Kobe City, Hyōgo, 650-0017, Japan.en_US
dc.description.affiliatesMarqués de Valdecilla University Hospital, Santander, 39008, Spain.en_US
dc.description.affiliatesMedical University of South Carolina, Mount Pleasant, SC 29425, USA.en_US
dc.description.affiliatesRaleigh Neurology Associates, Raleigh NC 27607, USA.en_US
dc.description.affiliatesOdense University Hospital, Odense, 5000, Denmark.en_US
dc.description.affiliatesSourasky Medical Center, Tel Aviv, 6423914, Israel.en_US
dc.description.affiliatesSydney Spine & Pain, Hurstville, NSW, 2220, Australia.en_US
dc.description.affiliatesSentara Neurosurgery Specialists, Virginia Beach, VA 23454, USA.en_US
dc.description.affiliatesSahlgrenska University Hospital, Gothenburg, 413 46, Sweden.en_US
dc.description.affiliatesComprehensive Spine & Sports Center, Campbell, CA 95008, USA.en_US
dc.description.affiliatesMetropolitan Pain Management Consultants, Sacramento, CA 95821, USA.en_US
dc.description.affiliatesUniversity Hospital Donostia, San Sebastián, 20014, Spain.en_US
dc.description.affiliatesAMPM Research Clinic, Miami Gardens, FL 33169, USA.en_US
dc.description.affiliatesIndiana University Health, Muncie, IN 47303, USA.en_US
dc.description.affiliatesConejo Pain Specialists Medical Group, Thousand Oaks, CA 91360, USA.en_US
dc.description.affiliatesInsight Neurosurgery, Dearborn Heights, MI 48091, USA.en_US
dc.description.affiliatesMississippi Sports Medicine & Orthopaedic Center, Jackson, MS 39110, USA.en_US
dc.description.affiliatesUniversity of Saskatchewan College of Medicine, Saskatoon, SK, S7N 5E5, Canada.en_US
dc.description.affiliatesAZ Delta, Roeselare, 8800, Belgium.en_US
dc.description.affiliatesCoastal Pain & Spinal Diagnostics, Carlsbad, CA 92009, USA.en_US
dc.description.affiliatesPain Management Centers of America, Evansville, IN 47714, USA.en_US
dc.description.affiliatesPain Medicine Associates, Newport Beach, CA 92663, USA.en_US
dc.description.affiliatesUniversity of Florida Health, Gainesville, FL 32610, USA.en_US
dc.description.affiliatesHyōgo College of Medicine Hospital, Nishinomiya, Hyōgo, 663-8501, Japan.en_US
dc.description.affiliatesThe Raso Pain Center, Jupiter, FL 33477, USA.en_US
dc.description.affiliatesPrecision Spine Care, Tyler, TX 75701, USA.en_US
dc.description.affiliatesInternational Hospital of Colombia, Bucaramanga - Piedecuesta, Santander, Columbia.en_US
dc.description.affiliatesKindai University, Faculty of Medicine, Osaka-sayama, Osaka, 577-8502, Japan.en_US
dc.description.affiliatesRijnstate Hospital, Arnhem, 6815, The Netherlands.en_US
dc.description.affiliatesPain Matrix, Berwick, Victoria, 3806, Australia.en_US
dc.description.affiliatesFundación CENIT, Buenos Aires, C1125 CABA, Argentina.en_US
dc.description.affiliatesUniversity of Illinois, Chicago, IL 60607, USA.en_US
dc.description.affiliatesThe Ohio State University Medical Center, Columbus, OH 43210, USA.en_US
dc.description.affiliatesTokyo Metropolitan Neurological Hospital, Tokyo, 150-0013, Japan.en_US
dc.description.affiliatesGreen Lizard Science, Claremont, Western Australia, 6010, Australia.en_US
dc.description.affiliatesBoston Scientific Neuromodulation, Valencia, CA 91355, USA.en_US
dc.description.pubmedurihttps://pubmed.ncbi.nlm.nih.gov/36691862/en_US
dc.type.studyortrialProspective Cohort Studyen_US
dc.type.specialtyAnaesthesiaen_US
dc.type.specialtyPain Medicineen_US
dc.identifier.fulltextlinkhttps://www.tandfonline.com/doi/full/10.2217/pmt-2022-0091en_US
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.grantfulltextrestricted-
item.cerifentitytypePublications-
item.fulltextWith Fulltext-
item.openairetypeJournal Article-
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