Clinical Trials in Orthopedic Disorders

STUDY PROTOCOL
Year
: 2016  |  Volume : 1  |  Issue : 4  |  Page : 145--151

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


Zheng-xi Yu, Xuan-huang Chen, Guo-dong Zhang, Xu Chen, Chang-fu Wu, Zu-gao Zheng, Xiao-qiang Gao, Hai-bin Lin 
 Department of Orthopedics, Affiliated Hospital of Putian University, Teaching Hospital of Fujian Medical University; Affiliated Putian Hospital of Southern Medical University; Affiliated Hospital of Putian University, Putian, Fujian Province, China

Correspondence Address:
Xuan-huang Chen
Department of Orthopedics, Affiliated Hospital of Putian University, Teaching Hospital of Fujian Medical University; Affiliated Putian Hospital of Southern Medical University; Affiliated Hospital of Putian University, Putian, Fujian Province
China

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. Here, we describe our protocol for testing the hypothesis that precise localization during minimally invasive lumbar pedicle screw placement can be achieved with the assistance of a 3D-printed module. Methods/Design: A single-center, self-controlled, open-label 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. 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. Trial registration: ClinicalTrials.gov identifier: NCT02970578. Ethics: The study protocol was approved by the Ethics Committee of the Affiliated Hospital of Putian University, Fujian Province, China, and performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Informed consent: Written informed consent was obtained from all participants prior to the trial.


How to cite this article:
Yu Zx, Chen Xh, Zhang Gd, Chen X, Wu Cf, Zheng Zg, Gao Xq, Lin Hb. 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.Clin Trials Orthop Disord 2016;1:145-151


How to cite this URL:
Yu Zx, Chen Xh, Zhang Gd, Chen X, Wu Cf, Zheng Zg, Gao Xq, Lin Hb. 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. Clin Trials Orthop Disord [serial online] 2016 [cited 2019 Aug 19 ];1:145-151
Available from: http://www.clinicalto.com/article.asp?issn=2542-4157;year=2016;volume=1;issue=4;spage=145;epage=151;aulast=Yu;type=0