Efficacy and safety of a digital navigation template combined with cervical pedicle screw implantation: study protocol for a prospective, single-center, self-controlled, clinical trial

doi:10.3969/j.issn.2095-4344.2017.35.011

Abstract

Abstract:

BACKGROUND: Cervical pedicle screw fixation is a reliable method for the treatment of traumatic and non-traumatic cervical instability and cervical disc removal and fixation; however, the operation risks and the failure rate of screw insertion are still high. At present, the digital navigation template with digital computer technology, used in the department of orthopedics, has the advantages of accurate screw insertion and a small error in the screw insertion depth.

OBJECTIVE: To observe the clinical efficacy and safety of the digital navigation template combined with cervical pedicle screw implantation.

METHODS: This is a prospective, single-center, self-controlled, clinical trial. Thirty-two patients with cervical spondylosis will be recruited from the Harrison International Peace Hospital, Hebei Province, China. Before surgery, a three-dimensional (3D) navigation model of the cervical vertebrae will be designed by 3D reconstruction. The navigation template will be generated by 3D printing. The cervical pedicle screws will be implanted according to preoperatively designed models and the screw positions will be observed by computerized tomography (CT) after surgery. The patients will be followed up for 40 months. The primary outcome measure is the excellent and good rate of screw position 40 months after implantation. The secondary outcome measures include the Visual Analog Scale score, American Spinal Injury Association classification, cervical X-ray and CT images before implantation and 40 months after implantation, and the incidence of adverse reactions 40 months after implantation. The protocols have been approved by the Ethics Committee of the Harrison International Peace Hospital in China (approval number: 20120630). The study protocol has been conducted in accordance with the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants. The recruitment of subjects will begin in December 2017. Samples and data will be collected from December 2017 to April 2019. Outcome measures will be analyzed in October 2020. This trial will be completed in November 2020. The results of the trial will be reported in a scientific conference or disseminated in a peer-reviewed journal. This trial has been registered in the Chinese Clinical Trial Registry (registration number: ChiCTR-ONC-17013481).

DISCUSSION: We will verify a high success rate of cervical pedicle screw implantation using the digital navigation template. The operation is simple and quick, with good efficacy and safety.

Key words: Tissue Engineering, Internal Fixation, Cervical Vertebrae

CLC Number:

R318

Wei Wei, Xing Long-yan, Jiao Jia-xun, Zhao Lei, Lu Ai-qing. Efficacy and safety of a digital navigation template combined with cervical pedicle screw implantation: study protocol for a prospective, single-center, self-controlled, clinical trial [J]. Chinese Journal of Tissue Engineering Research, 2017, 21(35): 5644-5648.

Figures/Tables 1

References

[1] 尹庆水,夏虹,吴增晖.经口寰枢椎复位内固定手术[M].北京:人民军医出版社,2010.

[2] Rodt T, Schlesinger A, Schramm A, et al. 3D visualization and simulation of frontoorbital advancement in metopic synostosis. Childs Nerv Syst. 2012;23(11):1313-1317.

[3] 张敏,王卫东,王玉强,等.前路齿状突中空螺钉导向仪的设计和解剖学研究[J].中华实验外科杂志,2014,31(5):1141-1143.

[4] 王岩.骨科精准医疗:应用与思考[J].中华医学杂志, 2015,9(31): 2512-2514.

[5] 李增春,陈德玉,吴德升,等.第三届全国颈椎病专题座谈会纪要[J].中华外科杂志,2008,46(23):1796-1799.

[6] 庄怀铭,郭跃跃,林勇彬,等.颈前路加压螺钉内固定治疗齿状突骨折的临床研究[J].中华全科医学,2012,10(7):1063-1065.

[7] Digioia AM. What is computer assisted orthopaedic surgery? Clin Orthop. 2013;354:2-4.

[8] 郝定均,贺宝荣,许正伟,等.寰椎"椎弓根"三维CT重建测量及分型的临床意义[J].中国脊柱脊髓杂志,2012,22(2):142-146.

[9] 段丽群,张文志,尚希福,等.颈前路空心加压螺钉治疗Ⅱ型齿状突骨折[J].临床骨科杂志,2011,14(3):244-246.

[10] Attias N. Lindsey RW. Starr AJ, et al. The use of a virtual three-dimensional model to evaluate the intraosseous space available for percutaneous screw fixation of acetabular fractures. J Bone Joint Surg Br. 2011;87(11):1520-1523.

[11] Yoshiharu K, Masato N, Taketoshi Y, et al. Development of a new technique for pedicle screw and Magerl screw insertion using a 3-dimensional image guide. Spine. 2012;37(23): 1983-1988.

[12] Knop C, Oeser M, Bastian L, et al. Development and validation of the Visual Analogue Scale (VAS) Spine Score. Unfallchirurg. 2011;104:488-497.

[13] Frankel HL, Hancock DO, Hyslop G, et al. The value of postural reduction in the initial management of closed injuries of the spine with paraplegia and tetraplegia. I. Paraplegia. 1969;7:179-192.

[14] 何宏伟,隋桐,赵慧毅,等.囊椎椎弓根螺钉置入相关参数的三维CT分析[J].中国组织工程研究,2012,16(9):1526-1529.

[15] Mouhsine E, Garofalo R, Borens O, et al. Acute total hip arthroplasty for acetabular fractures in the elderly: 11 patients followed for 2 years. Acta Orthop Scand. 2012;73:615-618.

[16] 尹华,赵银必.三种置钉方法在下颈椎经椎弓根螺钉置入过程中的比较[J].中国组织工程研究与临床康复, 2011;15(22): 4040-4044.

[17] Stockle U, Konig B, Dahne M, et al. Computer assisted pelvic and acetabular surgery. Clinical experiences and indications. Unfallchirurg. 2013;105:886-892.

[18] Gay SB, Sistrom C, Wang GJ, et al. Percutaneous srew fixation of acetabular fracture with CT guidancerrpreliminary results of a new teachnique. AJR Am J Roentgenol. 2012; 158:819.

[19] 朱希田,王以朋,徐杰.寰椎椎动脉沟变异与椎弓根置钉的三维CT分析[J].中国骨与关节外科,2014,7(6):451-455.

[20] Haidudewych GJ, Scaduto J, Herscovici D Jr. lartogenic nerve injury in acetabular fracture surgery: a comparison of monitored and unmonitored procedures. J Orthop Trauma. 2012;16(5):297-301.