Abstract
BackgroundConventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. Moreover, multi-time fluoroscope may prolong the operation time. 3D-printed template could help minimize fluoroscopy shot times and fluoroscopy dosage during operation, and shorten operation time. We perform this study to compare the efficacy and accuracy of PVP assisted by “three-dimensional printed individual guide template” versus conventional PVP.MethodPatients who suffered acute painful single segment osteoporotic vertebral compression fracture(OVCF) needed operative treatment were randomly assigned into three-dimensional printing individual guide template-assisted percutaneous vertebroplasty group (group A) or conventional PVP guided by C-arm fluoroscopy group (group B) at a 1:1 ratio. Fluoroscopy times for puncture points (FTPP), total radiation dosages (TRD), total fluoroscopy time (TFT), and total operation time (TOT) were recorded as the main evaluation factors to evaluate the two operation procedures.ResultsA total of 36 acute painful single segment OVCF patients were successfully operated on, and each group has 18 patients. None of the patients presented symptomatic complications. The surgical success rate in group A was 94.4%(17/18), one patient in the group A was failed and then operated by conventional procedure. FTPP (1.8 ± 0.8 in group A vs 5.2 ± 1.9 in group B, P < 0.05), TRD (4.9 ± 0.9 mGy vs 7.9 ± 1.6 mGy, P < 0.05), TFT (16.7 ± 2.9 vs 26.6 ± 5.3, P < 0.05), and total operation time (19.4 ± 2.4 min vs 27.8 ± 4.0 min, P < 0.05) were presented statistically difference in the two groups. The incidence of cement leakage occurred in group A (3/18, 16.7%) was less than that occurred in group B (7/18, 38.9%) (P > 0.05).ConclusionsCompared with the conventional PVP, “three-dimensional-printed individual guide template-assisted PVP” could minimize fluoroscopy shot times during operation and fluoroscopy dosage, shorten operation time, and is a more precise and feasible operation method.Trial registrationThe present study was registered with the Chinese Clinical Trial Registry (ChiCTR) (http://www.chictr.org.cn), and its registration no. is ChiCTR1900024283.
Highlights
With aging of the population, osteoporosis becomes increasingly common in the society
All participants were randomly divided into group A (PVP mainly assisted by three-dimensional-printed individual guide template) and group B (PVP mainly guided by C-arm fluoroscopy), the randomization ratio was 1:1 between group A and group B
percutaneous vertebroplasty (PVP) was recommended by guideline as one of the most effective treatments for the back pain caused by Osteoporotic vertebral compression fracture (OVCF) [22]
Summary
With aging of the population, osteoporosis becomes increasingly common in the society. The accuracy of the surgery mainly depends on the surgeons’ experience and multiple C-arm fluoroscopes during a conventional procedure. This procedure has the following drawbacks: (1) during conventional PVP, repeated fluoroscopes are needed to determine the optimal puncture points and to adjust the entry angles of puncture needles, which could lead to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. (4) For complicated OVCF, like patient with severe osteoporosis, severe kyphosis, scoliosis, or multisegment fractured vertebra, it commonly needs much more time and fluoroscope during operation procedure. Conventional percutaneous vertebroplasty (PVP) are mainly guided by C-arm fluoroscopy, and it usually leads to excessive X-ray radiation exposure to patients, surgeons, and anesthetists. We perform this study to compare the efficacy and accuracy of PVP assisted by “three-dimensional printed individual guide template” versus conventional PVP
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