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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
20 patients in group C received PPSF with pointed lotus-style regulator
20 patients in group B received PPSF with flat ended lotus-style regulator
The Huai'an Second People's Hospital
Huai'an, Jiangsu, China
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)
Time frame: 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.
Time frame: twenty-two months
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