Cobalt alloy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis: study protocol for a self-control trial

doi:10.3969/j.issn.2095-4344.2016.44.018

Abstract

Abstract:

BACKGROUND: There is evidence that internal fixation through an anterior or posterior approach for treatment of severe kyphotic deformity in spinal tuberculosis exhibits good curative effects. However, few prospective, long-term follow-up case control studies are reported.

OBJECTIVE: To investigate the efficacy and safety of cobalt alloy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis.

METHODS/DESIGN: This is a prospective, single-center, self-control, open-label trial, which will be performed at the Affiliated Hospital of Hebei University, China. Eighty-four patients with severe kyphotic deformity in spinal tuberculosis will be included according to the diagnosis criteria. Among 52 patients with tuberculosis of the thoracic spine, 28 will undergo surgery through a posterior approach, and 24 through an anterior approach. According to the Frankel Grade classification, grade C, D and E spinal cord function will be assessed in 8, 31 and 13 patients, respectively. Surgery through a posterior and anterior approach will be respectively performed in half of 32 patients with tuberculosis of the lumbar spine. Grade C, D and E spinal cord function will be assessed in 7, 14 and 11 patients, respectively. The primary outcome measure of this study will be the Cobb angle at the thoracic spine segments before and 2 years after surgery, which will be used to evaluate the angle of the spine curvature at the thoracic segments. The secondary outcome measures will be X-ray scan or MRI findings before and 2 years after surgery, which will be used to evaluate vertebral fusion after internal fixation; and Frankel Grade before and 2 years after surgery, which will be used to evaluate recovery of spinal cord function after injury. Other outcome measures will include multiple logistic regression analysis results of the factors that influence patient's curative effects and the incidence of adverse events 2 years after surgery. The trial protocol has been approved by the Ethics Committee, Affiliated Hospital of Hebei University, China and will be performed in strict accordance with the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding the trial protocol will be obtained from each participant.

DISCUSSION: This study is to validate that cobalt alloy pedicle screw implantation shows precise curative effects in the treatment of severe kyphotic deformity in spinal tuberculosis and to analyze through what approach, posterior or anterior, internal fixation will be more beneficial to surgery performance. The outcomes of this study will provide objective long-term follow-up evidence for internal fixation treatment of severe kyphotic deformity in spinal tuberculosis in the clinic.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Tuberculosis, Spinal, Kyphosis

CLC Number:

R318

Hou Yu, Yang Wen, Yang Fan, Bu Hong-jian, Wang Lin-jie, Liang Zhi-xing, Sun Bo, Shen Zhi-kun. Cobalt alloy pedicle screw implantation for treatment of severe kyphotic deformity in spinal tuberculosis: study protocol for a self-control trial[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(44): 6661-6666.

References

[1] Chopra R, Bhatt R, Biswas SK, et al. Epidemiological features of skeletal tuberculosis at an urban district tuberculosis centre. Indian J Tuberc. 2016;63(2):91-95.
[2] Izawa K, Kitada S. Clinical analysis of osteoarticular nontuberculous mycobacterial infection. Kekkaku. 2016;91(1):1-8.
[3] Kandwal PG, Jayaswal A. Management of Tuberculous Infection of the Spine. Asian Spine J. 2016;10(4): 792-800.
[4] Yu WY, Lou C, Liu FJ, et al. Clinical efficacy of one stage posterior debridement joint graft fixation for lumbar vertebral fractures in spinal tuberculosis patients with compression. Eur Rev Med Pharmacol Sci. 2016;20(15):3161-3167.
[5] Osman W, Braiki M, Alaya Z, et al. A Rare Case of Tuberculosis with Sacrococcygeal Involvement Miming a Neoplasm. Case Rep Orthop. 2016;2016:7286806.
[6] Wang YX, Zhang HQ, Tang MX, et al. One-stage posterior focus debridement, interbody grafts, and posterior instrumentation and fusion in the surgical treatment of thoracolumbar spinal tuberculosis with kyphosis in children: a preliminary report. Childs Nerv Syst. 2016;32:1495-1502.
[7] Patankar AP. Tuberculosis of spine: an experience of 30 cases over two years. Asian J Neurosurg. 2016; 11(3): 226-231.
[8] Wu P, Wang XY, Li XG, et al. One-stage posterior procedure in treating active thoracic spinal tuberculosis: a retrospective study. Eur J Trauma Emerg Surg. 2015; 41(2):189-197.
[9] 沈雄杰,李伟伟,王锡阳.胸腰段脊柱结核术后未愈及术后复发原因的探讨[J].医学临床研究,2011,28(4):616-619.
[10] Sonofuchi K, Hagiwara Y, Koizumi Y, et al. Quantitative in vivo biocompatibility of new ultralow-nickel cobalt-chromium-molybdenum alloys. J Orthop Res. 2016;34(9):1505-1513.
[11] Kim EC, Kim MK, Leesungbok R, et al. Co-Cr dental alloys induces cytotoxicity and inflammatory responses via activation of Nrf2/antioxidant signaling pathways in human gingival fibroblasts and osteoblasts. Dent Mater. 2016.
[12] Rakow A, Schoon J, Dienelt A, et al. Influence of particulate and dissociated metal-on-metal hip endoprosthesis wear on mesenchymal stromal cells in vivo and in vitro. Biomaterials. 2016;98:31-40.
[13] Sonofuchi K, Hagiwara Y, Koizumi Y, et al. Quantitative in vivo biocompatibility of new ultralow-nickel cobalt-chromium-molybdenum alloys. J Orthop Res. 2016;34(9):1505-1513.
[14] Al Mortadi N, Jones Q, Eggbeer D, et al. Fabrication of a resin appliance with alloy components using digital technology without an analog impression. Am J Orthod Dentofacial Orthop. 2015;148(5):862-867.
[15] Kiradzhiyska DD, Mantcheva RD, Mileva DL, et al. Investigation Of Chromium-Cobalt Coated Scaffolds On Cell Cultures In Vitro. Folia Med (Plovdiv). 2014; 56(4):275-281.
[16] Liu C, Matsunami C, Shirosaki Y, et al. Bioactive Co-Cr alloy for biomedical applications prepared by surface modification using self-assembled monolayers and poly-γ-glutamic acid. Dent Mater J. 2015;34(5): 707-712.
[17] Wu T, Chen X, Fan D, et al. Development and application of metal materials in terms of vascular stents. Biomed Mater Eng. 2015;25(4):435-441.
[18] Barsotti MC, Al Kayal T, Tedeschi L, et al. Oligonucleotide biofunctionalization enhances endothelial progenitor cell adhesion on cobalt/chromium stents. J Biomed Mater Res A. 2015;103(10):3284-3292.
[19] Mas-Moruno C, Garrido B, Rodriguez D, et al. Biofunctionalization strategies on tantalum-based materials for osseointegrative applications. J Mater Sci Mater Med. 2015;26(2):109.
[20] Logan N, Sherif A, Cross AJ, et al. TiO2-coated CoCrMo: improving the osteogenic differentiation and adhesion of mesenchymal stem cells in vitro. J Biomed Mater Res A. 2015;103(3):1208-1217.
[21] Capaul M, Zollinger H, Satz N, et al. Analyses of 94 consecutive spinal cord injury patients using ASIA definition and modified Frankel score classification. Paraplegia. 1994;32(9):583-587.
[22] Nuer Bo force Hari wood. Diagnostic criteria of spinal tuberculosis. Urumqi: Xinjiang Medical University. 2011.
[23] Jiang SD, Wu QZ, Lan SH, et al. Reliability of the measurement of thoracolumbar burst fracture kyphosis with Cobb angle, Gardner angle, and sagittal index. Arch Orthop Trauma Surg. 2012;132(2):221-225.