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| Name | Class |
|---|---|
| The Second People's Hospital of Huai'an | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Experimental | Group C were received PPSF with pointed lotus-style regulator |
|
| Group B | Experimental | Group B were received PPSF with Flat ended lotus root regulator |
|
| Group A | No Intervention | Group A were received traditional PPSF |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pointed lotus root regulator and guide template aided PPSF | Device | 20 patients in group C received PPSF with pointed lotus-style regulator |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quan Zhou, Zhou | The Second People's Hospital of Huai'an | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Huai'an Second People's Hospital | Huai'an | Jiangsu | 223002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31932574 | Result | 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. | |
| 35190566 | Derived |
| Label | URL |
|---|---|
| This work is licensed under Creative Common AttributionNonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0) | View source |
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Wait for the results of related parallel trials before considering sharing data
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2018 | Jul 18, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| Flat ended lotus root regulator and guide template aided PPSF | Device | 20 patients in group B received PPSF with flat ended lotus-style regulator |
|
| 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. |