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dc.contributor.authorNunley, Pierce
dc.contributor.authorStrenge, K Brandon
dc.contributor.authorHuntsman, Kade
dc.contributor.authorBae, Hyun
dc.contributor.authorDiPaola, Christian
dc.contributor.authorT, Allen R
dc.contributor.authorShaw, Andrew
dc.contributor.authorSasso, Rick C
dc.contributor.authorAraghi, Ali
dc.contributor.authorStaub, Blake
dc.contributor.authorChen, Selby
dc.contributor.authorMiller, Larry E
dc.contributor.authorMusacchio, Michael
dc.date.accessioned2023-04-07T20:11:58Z
dc.date.available2023-04-07T20:11:58Z
dc.date.issued2021-12-08
dc.identifier.citationNunley P, Strenge KB, Huntsman K, Bae H, DiPaola C, T AR, Shaw A, Sasso RC, Araghi A, Staub B, Chen S, Miller LE, Musacchio M. Lumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Study. Cureus. 2021 Dec 8;13(12):e20274. doi: 10.7759/cureus.20274. PMID: 35018268; PMCID: PMC8741419.en_US
dc.identifier.issn2168-8184
dc.identifier.doi10.7759/cureus.20274en_US
dc.identifier.pmid35018268
dc.identifier.urihttp://hdl.handle.net/20.500.14038/51930
dc.description.abstractBackground Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited. Methods This was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing. Results Among 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed. Conclusion Among patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.en_US
dc.language.isoenen_US
dc.relation.ispartofCureusen_US
dc.relation.urlhttps://doi.org/10.7759/cureus.20274en_US
dc.rights© Copyright 2021 Nunley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.en_US
dc.rightsAttribution 4.0 International*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectannular defecten_US
dc.subjectbarricaiden_US
dc.subjectlumbar discectomyen_US
dc.subjectlumbar herniationen_US
dc.subjectsciaticaen_US
dc.titleLumbar Discectomy With Barricaid Device Implantation in Patients at High Risk of Reherniation: Initial Results From a Postmarket Studyen_US
dc.typeJournal Articleen_US
dc.source.journaltitleCureus
dc.source.volume13
dc.source.issue12
dc.source.beginpagee20274
dc.source.endpage
dc.source.countryUnited States
dc.identifier.journalCureus
refterms.dateFOA2023-04-07T20:11:59Z
dc.contributor.departmentOrthopedics and Physical Rehabilitationen_US


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© Copyright 2021
Nunley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Except where otherwise noted, this item's license is described as © Copyright 2021 Nunley et al. This is an open access article distributed under the terms of the Creative Commons Attribution License CC-BY 4.0., which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.