Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator

Not Applicable

Completed

• Conditions: Vertebral Fracture
• Interventions: Device: Pointed lotus root regulator and guide template aided PPSF; Device: Flat ended lotus root regulator and guide template aided PPSF

• Registration Number: NCT04980131
• Lead Sponsor: Ming Zhang

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.

Study Timeline

• Study Start: 2018-06-06
• Primary Completion: 2020-05-28
• Study Completion: 2020-06-30
• Status Verified: 2021-07
• Study First Submitted: 2021-07-08
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C	Pointed lotus root regulator and guide template aided PPSF	Group C were received PPSF with pointed lotus-style regulator
Group B	Flat ended lotus root regulator and guide template aided PPSF	Group B were received PPSF with Flat ended lotus root regulator

Primary Outcome Measures

Name	Time	Method
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	twenty months	All the operations were successfully completed. The number of pedicles successfully first pierced in group C was higher than that in group A and group B (P\<0.05);The number of insertion, fluoroscopy and operation time before the insertion needle reached the ideal position, the total number and time of intraoperative fluoroscopy, and the intraoperative blood loss in group C were all significantly lower than those of group A and group B (P\<0.05)
VAS scores after surgery	twenty-two months	All patients were followed up 6 months after surgery. VAS scores at 1 day and 7 days after surgery were higher in Group A than those in other groups（P\<0.05）, but no differences were found VAS scores at 1 , 3 and 6 months after surgery in 3 groups.Specific methods: drawing a 10cm line on the paper, one end of the horizontal line is 0, that is painless; The other end is 10, which means severe pain; The intermediate part indicates different levels of pain. Asking the patient to mark the level of pain on a horizontal line according to how he or she feels. 0-2: meaning comfortable; 3-4: slight discomfort; 5-6: moderate discomfort; 7-8: Severe discomfort;9-10: Extreme discomfort.

Trial Locations

Locations (1)

The Huai'an Second People's Hospital; 🇨🇳 Huai'an, Jiangsu, China