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

Primary Purpose

Vertebral Fracture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pointed lotus root regulator and guide template aided PPSF
Flat ended lotus root regulator and guide template aided PPSF
Sponsored by
Ming Zhang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vertebral Fracture focused on measuring 3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • The Huai'an Second People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group C

Group B

Group A

Arm Description

Group C were received PPSF with pointed lotus-style regulator

Group B were received PPSF with Flat ended lotus root regulator

Group A were received traditional PPSF

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2021
Last Updated
July 18, 2021
Sponsor
Ming Zhang
Collaborators
The Second People's Hospital of Huai'an
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1. Study Identification

Unique Protocol Identification Number
NCT04980131
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ming Zhang
Collaborators
The Second People's Hospital of Huai'an

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture
Keywords
3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Experimental
Arm Description
Group C were received PPSF with pointed lotus-style regulator
Arm Title
Group B
Arm Type
Experimental
Arm Description
Group B were received PPSF with Flat ended lotus root regulator
Arm Title
Group A
Arm Type
No Intervention
Arm Description
Group A were received traditional PPSF
Intervention Type
Device
Intervention Name(s)
Pointed lotus root regulator and guide template aided PPSF
Intervention Description
20 patients in group C received PPSF with pointed lotus-style regulator
Intervention Type
Device
Intervention Name(s)
Flat ended lotus root regulator and guide template aided PPSF
Intervention Description
20 patients in group B received PPSF with flat ended lotus-style regulator
Primary Outcome Measure Information:
Title
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
Description
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)
Time Frame
twenty months
Title
VAS scores after surgery
Description
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.
Time Frame
twenty-two months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Zhou, Zhou
Organizational Affiliation
The Second People's Hospital of Huai'an
Official's Role
Study Director
Facility Information:
Facility Name
The Huai'an Second People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223002
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Wait for the results of related parallel trials before considering sharing data
Citations:
PubMed Identifier
31932574
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.
Results Reference
result
PubMed Identifier
35190566
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.
Results Reference
derived
Links:
URL
http://www.medscimonit.com/abstract/index/idArt/920578
Description
This work is licensed under Creative Common AttributionNonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)

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

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