Rapid Implementation of a 3-Dimensional-Printed Patient-Specific Titanium Sacrum Implant for Severe Neuropathic Spinal Arthropathy and Guide to Compassionate US Regulatory Approval.
Journal
Operative neurosurgery (Hagerstown, Md.)
ISSN: 2332-4260
Titre abrégé: Oper Neurosurg (Hagerstown)
Pays: United States
ID NLM: 101635417
Informations de publication
Date de publication:
01 11 2023
01 11 2023
Historique:
received:
16
02
2023
accepted:
31
05
2023
medline:
23
10
2023
pubmed:
16
8
2023
entrez:
16
8
2023
Statut:
ppublish
Résumé
Rapid design and production of patient-specific 3-dimensional-printed implants (3DPIs) present a novel opportunity to restore the biomechanically demanding integrity of the lumbopelvic junction. We present a unique case of a 61-year-old patient with severe neuropathic spinal arthropathy (Charcot spine) who initially underwent a T4-to-sacrum spinal fusion. Massive bone destruction led to dissociation of his upper body from his pelvis and legs. Reconstruction of the spinopelvic continuity was planned with the aid of a personalized lumbosacral 3DPI. Using high-resolution computed tomography scans, the custom 3DPI was made using additive titanium manufacturing. The unique 3DPI consisted of (1) a sacral platform with iliac screws, (2) modular corpectomy device with rigid connection to the sacral platform, and (3) anterior plate connection with screws for proximal fixation. The procedures to obtain compassionate use Food and Drug Administration approval were followed. The patient underwent debridement of a chronically open wound before undertaking the 3-stage reconstructive procedure. The custom 3DPI and additional instrumentation were inserted as part of a salvage rebuilding procedure. The chronology of the rapid implementation of the personalized sacral 3DPI from decision, design, manufacturing, Food and Drug Administration approval, and surgical execution lasted 28 days. The prosthesis was positioned in the defect according to the expected anatomic planes and secured using a screw-rod system and a vascularized fibular bone strut graft. The prosthesis provided an ideal repair of the lumbosacral junction and pelvic ring by merging spinal pelvic fixation, posterior pelvic ring fixation, and anterior spinal column fixation. To the best of our knowledge, this is the first case of a multilevel lumbar, sacral, and sacropelvic neuropathic (Charcot) spine reconstruction using a 3DPI sacral prosthesis. As the prevalence of severe spine deformities continues to increase, adoption of 3DPIs is becoming more relevant to offer personalized treatment for complex deformities.
Sections du résumé
BACKGROUND AND OBJECTIVE
Rapid design and production of patient-specific 3-dimensional-printed implants (3DPIs) present a novel opportunity to restore the biomechanically demanding integrity of the lumbopelvic junction. We present a unique case of a 61-year-old patient with severe neuropathic spinal arthropathy (Charcot spine) who initially underwent a T4-to-sacrum spinal fusion. Massive bone destruction led to dissociation of his upper body from his pelvis and legs. Reconstruction of the spinopelvic continuity was planned with the aid of a personalized lumbosacral 3DPI.
METHOD
Using high-resolution computed tomography scans, the custom 3DPI was made using additive titanium manufacturing. The unique 3DPI consisted of (1) a sacral platform with iliac screws, (2) modular corpectomy device with rigid connection to the sacral platform, and (3) anterior plate connection with screws for proximal fixation. The procedures to obtain compassionate use Food and Drug Administration approval were followed. The patient underwent debridement of a chronically open wound before undertaking the 3-stage reconstructive procedure. The custom 3DPI and additional instrumentation were inserted as part of a salvage rebuilding procedure.
RESULTS
The chronology of the rapid implementation of the personalized sacral 3DPI from decision, design, manufacturing, Food and Drug Administration approval, and surgical execution lasted 28 days. The prosthesis was positioned in the defect according to the expected anatomic planes and secured using a screw-rod system and a vascularized fibular bone strut graft. The prosthesis provided an ideal repair of the lumbosacral junction and pelvic ring by merging spinal pelvic fixation, posterior pelvic ring fixation, and anterior spinal column fixation.
CONCLUSION
To the best of our knowledge, this is the first case of a multilevel lumbar, sacral, and sacropelvic neuropathic (Charcot) spine reconstruction using a 3DPI sacral prosthesis. As the prevalence of severe spine deformities continues to increase, adoption of 3DPIs is becoming more relevant to offer personalized treatment for complex deformities.
Identifiants
pubmed: 37584482
doi: 10.1227/ons.0000000000000872
pii: 01787389-202311000-00011
doi:
Substances chimiques
Titanium
D1JT611TNE
Types de publication
Case Reports
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
469-477Informations de copyright
Copyright © Congress of Neurological Surgeons 2023. All rights reserved.
Références
Barrey C, Massourides H, Cotton F, Perrin G, Rode G. Charcot spine: two new case reports and a systematic review of 109 clinical cases from the literature. Ann Phys Rehabil Med. 2010;53(3):200-220.
Brown CW, Jones B, Donaldson DH, Akmakjian J, Brugman JL. Neuropathic (Charcot) arthropathy of the spine after traumatic spinal paraplegia. Spine. 1992;17(Supplement):S103-S108.
Devlin VJ, Ogilvie JW, Transfeldt EE, Boachie-Adjei O, Bradford DS. Surgical treatment of neuropathic spinal arthropathy. J spinal Disord. 1991;4(3):319-328.
Sobel J, Bohlman H, Freehafer A. Charcot's arthropathy of the spine following spinal cord injury. A report of five cases. J Bone Joint Surg. 1985;67(5):771-776.
Standaert C, Cardenas DD, Anderson P. Charcot spine as a late complication of traumatic spinal cord injury. Arch Phys Med Rehabil. 1997;78(2):221-225.
Shah FA, Snis A, Matic A, Thomsen P, Palmquist A. 3D printed Ti6Al4V implant surface promotes bone maturation and retains a higher density of less aged osteocytes at the bone-implant interface. Acta Biomater. 2016;30:357-367.
Wei R, Guo W, Ji T, Zhang Y, Liang H. One-step reconstruction with a 3D-printed, custom-made prosthesis after total en bloc sacrectomy: a technical note. Eur Spine J. 2017;26(7):1902-1909.
Kim D, Lim J-Y, Shim K-W, et al. Sacral reconstruction with a 3D-printed implant after hemisacrectomy in a patient with sacral osteosarcoma: 1-year follow-up result. Yonsei Med J. 2017;58(2):453-457.
Zileli M, Hoscoskun C, Brastianos P, Sabah D. Surgical treatment of primary sacral tumors: complications associated with sacrectomy. Neurosurg Focus. 2003;15(5):1-8.
Fiani B, Newhouse A, Cathel A, Sarhadi K, Soula M. Implications of 3-dimensional printed spinal implants on the outcomes in spine surgery. J Korean Neurosurg Soc. 2021;64(4):495-504.
Ahmed AK, Pennington Z, Molina CA, Xia Y, Goodwin CR, Sciubba DM. Multidisciplinary surgical planning for en bloc resection of malignant primary cervical spine tumors involving 3D-printed models and neoadjuvant therapies: report of 2 cases. J Neurosurg Spine. 2019;30(4):424-431.
Chin BZ, Ji T, Tang X, Yang R, Guo W. Three-level lumbar en bloc spondylectomy with three-dimensional-printed vertebrae reconstruction for recurrent giant cell tumor. World Neurosurg. 2019;129:531-537. e1.
Choy WJ, Mobbs RJ, Wilcox B, Phan S, Phan K, Sutterlin CE III. Reconstruction of thoracic spine using a personalized 3D-printed vertebral body in adolescent with T9 primary bone tumor. World Neurosurg. 2017;105:1032.e13-1032.e17.
Li X, Wang Y, Zhao Y, Liu J, Xiao S, Mao K. Multilevel 3D printing implant for reconstructing cervical spine with metastatic papillary thyroid carcinoma. Spine. 2017;42(22):e1326-e1330.
Mobbs RJ, Coughlan M, Thompson R, Sutterlin CE, Phan K. The utility of 3D printing for surgical planning and patient-specific implant design for complex spinal pathologies: case report. J Neurosurg Spine. 2017;26(4):513-518.
Xiao Jr, Huang Wd, Yang Xh, et al. En bloc resection of primary malignant bone tumor in the cervical spine based on 3-dimensional printing technology. Orthopaedic Surg. 2016;8(2):171-178.
Xu N, Wei F, Liu X, et al. Reconstruction of the upper cervical spine using a personalized 3D-printed vertebral body in an adolescent with Ewing sarcoma. Spine. 2016;41(1):E50–E54.
Mobbs RJ, Parr WCH, Huang C, Amin T. Rapid personalised virtual planning and on-demand surgery for acute spinal trauma using 3D-printing, biomodelling and patient-specific implant manufacture. J Pers Med. 2022;12(6):997.
Lv Z-R, Li Z-F, Yang Z-P, et al. One-step reconstruction with a novel suspended, modular, and 3D-printed total sacral implant resection of sacral giant cell tumor with preservation of bilateral S1-3 nerve roots via a posterior-only approach. Orthop Surg. 2020;12(1):58-66.
Thayaparan GK, Owbridge MG, Thompson RG, D'Urso PS. Designing patient-specific solutions using biomodelling and 3D-printing for revision lumbar spine surgery. Eur Spine J. 2019;28(suppl 2):18-24.
Wei R, Guo W, Ji T, Zhang Y, Liang H. One-step reconstruction with a 3D-printed, custom-made prosthesis after total en bloc sacrectomy: a technical note. Eur Spine J. 2017;26(7):1902-1909.
Wei R, Guo W, Yang R, et al. Reconstruction of the pelvic ring after total en bloc sacrectomy using a 3D-printed sacral endoprosthesis with re-establishment of spinopelvic stability: a retrospective comparative study. Bone Joint J. 2019;101-B(7):880-888.
Chatain GP, Finn M. Compassionate use of a custom 3D-printed sacral implant for revision of failing sacrectomy: case report. J Neurosurg Spine. 2020;33(4):513-518.
Food and Drug Administration. Expanded Access for Medical Devices. Food and Drug Administration; 2019.
Food and Drug Administration. Custom Device Exemption Guidance for Industry and Food and Drug Administration Staff. Food and Drug Administration; 2014.
Trace AP, Ortiz D, Deal A, et al. Radiology’s emerging role in 3-D printing applications in health care. J Am Coll Radiol. 2016;13(7):856-862. e4.
Choy WJ, Mobbs RJ. Current state of 3D-printed custom-made spinal implants. Lancet Digit Health. 2019;1(4):e149-e150.