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

M

Ming Zhang

Status

Completed

Conditions

Vertebral Fracture

Treatments

Device: Flat ended lotus root regulator and guide template aided PPSF
Device: Pointed lotus root regulator and guide template aided PPSF

Study type

Interventional

Funder types

Other

Identifiers

NCT04980131
HEYLL201705

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

50 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 3 patient groups

Group C
Experimental group
Description:
Group C were received PPSF with pointed lotus-style regulator
Treatment:
Device: Pointed lotus root regulator and guide template aided PPSF
Group B
Experimental group
Description:
Group B were received PPSF with Flat ended lotus root regulator
Treatment:
Device: Flat ended lotus root regulator and guide template aided PPSF
Group A
No Intervention group
Description:
Group A were received traditional PPSF

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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