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

July 18, 2021 updated by: Ming Zhang

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Huai'an, Jiangsu, China, 223002
        • The Huai'an Second People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group C
Group C were received PPSF with pointed lotus-style regulator
Device: Pointed lotus root regulator and guide template aided PPSF
20 patients in group C received PPSF with pointed lotus-style regulator
Experimental: Group B
Group B were received PPSF with Flat ended lotus root regulator
Device: Flat ended lotus root regulator and guide template aided PPSF
20 patients in group B received PPSF with flat ended lotus-style regulator
No Intervention: Group A
Group A were received traditional PPSF

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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)
twenty months
VAS scores after surgery
Time Frame: 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.
twenty-two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming Zhang

Collaborators

The Second People's Hospital of Huai'an

Investigators

  • Study Director: Quan Zhou, Zhou, The Second People's Hospital of Huai'an

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2018

Primary Completion (Actual)

May 28, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

July 8, 2021

First Submitted That Met QC Criteria

July 18, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

July 28, 2021

Last Update Submitted That Met QC Criteria

July 18, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEYLL201705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Wait for the results of related parallel trials before considering sharing data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vertebral Fracture

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe