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
10.3969/j.issn.2095-4344.2017.35.011
- VernacularTitle:数字化导航模板技术联合颈椎椎弓根螺钉植入的有效性及安全性:前瞻性、单中心、自身对照临床试验方案
- Author:
Wei WEI
1
;
yan Long XING
;
xun Jia JIAO
;
Lei ZHAO
;
qing Ai LU
Author Information
1. 河北省哈励逊国际和平医院骨病科
- From:
Chinese Journal of Tissue Engineering Research
2017;21(35):5644-5648
- CountryChina
- Language:Chinese
-
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.
