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

Vertebral Fracture Clinical Trial

Official title:

Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator in Percutaneous Pedicle Screw Fixation for Thoracolumbar Fractures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980131
• Other study ID #: HEYLL201705
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: July 2021
• Source: The Second People's Hospital of Huai'an
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Spinal Fractures
• Vertebral Fracture

Intervention

Device:
• Pointed lotus root regulator and guide template aided PPSF
20 patients in group C received PPSF with pointed lotus-style regulator
• Flat ended lotus root regulator and guide template aided PPSF
20 patients in group B received PPSF with flat ended lotus-style regulator

Locations

Country	Name	City	State
China	The Huai'an Second People's Hospital	Huai'an	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Ming Zhang	The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	twenty months
Primary	VAS scores after surgery	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.	twenty-two months

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