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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Vertebral Fracture

Intervention / Treatment
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* Device: Pointed lotus root regulator and guide template aided PPSF
* Device: Flat ended lotus root regulator and guide template aided PPSF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation