3D-printed module-assisted minimally invasive lumbar pedicle screw placement: study protocol for a self-controlled, open-label clinical trial with 2-year follow-up

doi:10.3969/j.issn.2095-4344.2016.53.010

Abstract

Abstract:

BACKGROUND: Minimally invasive pedicle screw fixation is an effective treatment for thoracolumbar diseases, but skilled operations are required during the internal fixation. If inaccurate implantation occurs, adverse reactions will appear postoperatively; for example, the implanted screw will fall off. 3D printing can manufacture a suitable implant for a patient, accurately simulate the repair process, and reduce the difficulty and complexity of the operation, aiming to produce an implant that is most suitable for repair surgery.

OBJECTIVE: To verify that precise localization during minimally invasive lumbar pedicle screw placement can be achieved with the assistance of a 3D-printed module.

METHODS: A single-center, self-controlled, open-label clinical study with 2-year follow-up was carried out at the Affiliated Hospital of Putian University, Putian, Fujian Province, China. Preoperative thin-layer CT data from 36 cases of lumbar spine fixation were collected and digitally reconstructed using Mimics software. An ideal channel for screw insertion via the vertebral pedicle was preset, and a 3D-printed navigation module with a screw channel was designed and printed based on the anatomical structures of the bone surface that could be stripped around the screw channel. Minimally invasive pedicle screw fixation was then navigated by the 3D-printed module using the Quadrant system. A thin-layer CT scan was used for postoperative three-dimensional reconstruction. The primary outcome measure was accurate rate of screw placement, which was used to assess whether the screw placement under navigation by the 3D-printed module achieved the desired results. Secondary outcome measures included lumbar CT results preoperatively, 6 and 24 months postoperatively, operation time, intraoperative blood loss, duration of radiation exposure, and incidence of adverse events at 6 and 24 months postoperatively. Some results from the completed surgery are given below: the time of operation, amount of bleeding and duration of radiation exposure were (120.58 ± 56.46) minutes, (136.83±40.62) mL, and (50±11) seconds, respectively. A total of 186 screws were inserted in the patients, with a 98% accuracy rate. This trial was registered at ClinicalTrials.gov (NCT02970578) on 16 November 2016. Approved by the Ethics Committee of Putian University, Fujian Province, China, the study protocol was performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association.Written informed consent was obtained from all participants prior to the trial. Patient recruitment began at November 2012 and lasted until November 2015, and follow-up data collection will be accomplished until March 2017.

DISCUSSION: The study aims to test our hypothesis that a 3D-printed module is a valuable aid for screw localization in minimally invasive lumbar pedicle screw placement, providing clinical data for 3D-printed module-assisted minimally invasive lumbar surgery using the Quadrant system.

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, Lumbar Vertebrae, Internal Fixators

CLC Number:

R318

Yu Zheng-xi, Chen Xuan-huang, Zhang Guo-dong, Chen Xu, Wu Chang-fu, Zheng Zu-gao, Gao Xiao-qiang, Lin Hai-bin. 3D-printed module-assisted minimally invasive lumbar pedicle screw placement: study protocol for a self-controlled, open-label clinical trial with 2-year follow-up[J]. Chinese Journal of Tissue Engineering Research, 2016, 20(53): 7973-7978.

Figures/Tables 1

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