Application of 3-Dimensional Printing Guide Template and Pointed Lotus-style Regulator
NCT ID: NCT04980131
Last Updated: 2021-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2018-06-06
2020-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group C
Group C were received PPSF with pointed lotus-style regulator
Pointed lotus root regulator and guide template aided PPSF
20 patients in group C received PPSF with pointed lotus-style regulator
Group B
Group B were received PPSF with Flat ended lotus root regulator
Flat ended lotus root regulator and guide template aided PPSF
20 patients in group B received PPSF with flat ended lotus-style regulator
Group A
Group A were received traditional PPSF
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
60 Years
ALL
No
Sponsors
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The Second People's Hospital of Huai'an
OTHER
Ming Zhang
OTHER
Responsible Party
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Ming Zhang
medium-grade professional title
Principal Investigators
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Quan Zhou, Zhou
Role: STUDY_DIRECTOR
The Second People's Hospital of Huai'an
Locations
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The Huai'an Second People's Hospital
Huai'an, Jiangsu, China
Countries
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References
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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.
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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This work is licensed under Creative Common AttributionNonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0)
Other Identifiers
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HEYLL201705
Identifier Type: -
Identifier Source: org_study_id
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