Thoracolumbar; Spina Bifida Clinical Trial
Official title:
3D-printed Module-assisted Minimally Invasive Lumbar Pedicle Screw Placement: a Retrospective, Self-controlled, Open-label Clinical Trial
To explore the accuracy of 3D printed module assisted minimally invasive lumbar pedicle screw placement using Quandrant system, and verify its feasibility of reducing error rate of screw placement and postoperative complications.
History and current related studies Pedicle screw fixation has been widely used in spinal
surgery, such as spinal fractures, lumbar spondylolisthesis, scoliosis, lumbar spinal
stenosis. However, difficulties in pedicle screw placement are unavoidable because of
anatomical variations in the spinal structure and spinal degeneration. Consequently, the
precise localization for screw placement is essential. If not, errors in screw placement
will result in reduced strength or even failure of the internal fixation, which may lead to
a series of injuries, including nerve root injury, dural sac tear, vascular injury and even
spinal cord injury. To conclude, it is urgent to improve the accuracy of screw placement and
reduce complications of screw placement in the pedicle screw fixation.
With the rapid adoption of digital medicine and 3D printing technology in orthopedic
practice, 3D techniques, based on preoperative high-resolution CT scan data, can
theoretically restore the three-dimensional structure of the bone. That is to say, the
investigators can present a detailed description of the complex anatomical structure of the
bone, to accurately make a preoperative plan and an intraoperative simulation. Numerous
evidences have been achieved with digital three-dimensional reconstruction and 3D techniques
to assist the posterior pedicle screw fixation in the treatment of spine lesions.
Adverse events Postoperative adverse events were recorded and reported to the Affiliated
Hospital of Putian Hospital within 24 hours.
Proper therapeutic measures could be performed if the following adverse events occurred,
including incision infection, back muscle pain, dural sac tear, vascular injury, nerve root
injury, spinal cord injury, screw falling off and loosening.
Data collection, management, analysis, and open access Baseline data were collected at the
day when the participants were enrolled in the study. Other data were collected
preoperatively, intraoperatively, postoperatively and during the follow-up. All data were
input using Epidata and saved electronically.
All data regarding this clinical study were preserved by the Affiliated Hospital of Putian
University, China.
All data were statistically analyzed by professional statisticians who were responsible for
completing an outcome analysis report that was submitted to the project manager who was
responsible for completing a research report. An independent data monitoring committee was
responsible for data monitoring and management throughout the entire trial.
Statistical analysis All data were statistically analyzed by statisticians using SPSS 19.0
software (IBM Corporation, Armonk, NY, USA) in accordance with the intention-to-treat
principle.
Normally distributed measurement data were expressed as means, standard deviations,
minimums, and maximums; non-normally distributed data were expressed as lower quartiles,
medians, and upper quartiles.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment