Abstract

BACKGROUND CONTEXT Osteoporotic vertebral fractures (OVF) are a hallmark of osteoporosis and are the most prevalent fracture. PURPOSE Percutaneous vertebroplasty (PVP) has been demonstrated to be effective in the treatment of OVF. However, the matter of which surgical approach should be selected remains controversial. This study aimed to find a safer and better way for patients treated with cement augmentation technique through fluid dynamics theory to prevent cement leakage. STUDY DESIGN/SETTING Randomized controlled trials and biomechanics analysis PATIENT SAMPLE In vitro, 36 standardized osteoporotic porcine vertebrae body series (T10-L3) were developed. In vivo, from January 2015 to December 2018, 68 patients with OVF were randomly assigned to the unilateral puncture group (n=36) or the bilateral group (n=32). OUTCOME MEASURES In vitro, specimens were imaged with plain radiology, mounted on the testing apparatus, and histologic examination. In vivo, these patients underwent percutaneous injection of PMMA into posterior pedicle by the unilateral or bilateral puncture approach. Visual analogue scale (VAS) and the Quality of Life were recorded on presentation, at 1 week, 3, 6, and 12 months after operation. The cement leakage was measured by x-ray and computed tomography scan. METHODS Two different cement augmentation techniques were assessed with polymethyl methacrylate (PMMA) under unilateral vertebroplasty and bilateral vertebroplasty with continuous negative pressure to the contralateral side of the vertebral body. RESULTS The leakage rate was significantly lower in the continuous-negative pressure system than unilateral puncture approach. Excellent cross-filling of bone cement, better stress-resist power, better digitation of cement under histology examination were in negative pressure group. As for patient follow-up data showed there were no significant differences in VAS and QUALEFFO between two groups after PVP between two groups at 3, 6, and 12 months after operation. The cement leakage was higher in the unilateral puncture group than in the bilateral group. CONCLUSIONS Cement injection combined with continuous negative pressure system to the contralateral side of the vertebral body is a simple approach to minimize the risk for leakage. It offers surgeon a more secure and effective way to perform augmentation technique and reduces the likelihood of cement leakage and pulmonary embolism. FDA DEVICE/DRUG STATUS This abstract does not discuss or include any applicable devices or drugs.

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