Vertebral Fracture
Conditions
Keywords
3D printing guide template, pointed lotus-style regulator, thoracolumbar compression fracture, percutaneous pedicle screw fixation
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.
Interventions
DEVICEPointed lotus root regulator and guide template aided PPSF
20 patients in group C received PPSF with pointed lotus-style regulator
DEVICEFlat ended lotus root regulator and guide template aided PPSF
20 patients in group B received PPSF with flat ended lotus-style regulator
Sponsors
The Second People's Hospital of Huai'an
Ming Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| VAS scores after surgery | 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. |
Countries
China
Outcome results
None listed