Clinical trial NCT04980131: Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator
Official title: Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vertebral Fracture
Keywords: 3D printing guide template
pointed lotus-style regulator
thoracolumbar compression fracture
percutaneous pedicle screw fixation
Lead sponsor: The Second People's Hospital of Huai'an
Sponsor class: OTHER
Collaborators: name: The Second People's Hospital of Huai'an
First posted: 2021-07-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to analysis the efficacy of the 3D printing percutaneous guide template in combination with the pointed lotus-style regulator in percutaneous pedicle screw fixation.

Detailed description: All thoracolumbar fractures patients receiving percutaneous pedicle screw fixation (PPSF) were enrolled and randomly divided into 3 groups. Patients in Group A received traditional PPSF, while patients in Group B received PPSF with flat end lotus-style regulator and patients in Group C received PPSF with pointed lotus-style regulator.

Eligibility criteria: Inclusion Criteria:

* The thoracolumbar vertebral compression fracture which the injury time is less than 7 days
* The vertebral fracture sites where are located in T11-L2
* No clinical neurological symptoms and signs
* The patients who have complete preoperative X-ray, CT, MRI and other imaging data

Exclusion Criteria:

* Vertebral burst fracture with spinal canal occupation
* Fracture caused by severe osteoporosis or tumor and other pathological factors
* Moderate and severe scoliosis
* Patients with pedicle dysplasia
* Patients with severe heart, liver and kidney diseases, diabetes, immune diseases, mental diseases who cannot tolerate surgery
* Coagulation dysfunction or surgical site of the skin infection

Primary outcomes:
measure: First puncture success rate,number of insertions before reaching the desired position, number of fluoroscopy before reaching the desired position, radiation dosage before reaching the desired position, operation time before reaching the desired position
timeFrame: twenty months
measure: VAS scores after surgery
timeFrame: twenty-two months
Secondary outcomes:
Other outcomes:
Locations:
city: Huai'an
country: China
facility: The Huai'an Second People's Hospital
state: Jiangsu
Study officials:
affiliation: The Second People's Hospital of Huai'an
name: Quan Zhou, Zhou
role: STUDY_DIRECTOR
References:
citation: Zhang M, Li J, Fang T, Zhao J, Pan W, Wang X, Xu J, Zhou Q. Evaluation of a Three-Dimensional Printed Guide and a Polyoxymethylene Thermoplastic Regulator for Percutaneous Pedicle Screw Fixation in Patients with Thoracolumbar Fracture. Med Sci Monit. 2020 Jan 14;26:e920578. doi: 10.12659/MSM.920578.
citation: Zhang M, Li J, Fang T, Yan J, Wu L, Zhou Q. Application of 3-dimensional printing guide template and pointed lotus-style regulator in percutaneous pedicle screw fixation for thoracolumbar fractures. Sci Rep. 2022 Feb 21;12(1):2930. doi: 10.1038/s41598-022-06256-x.