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To develop an alarm device for the mechanical compression device displacement (MCD), and further evaluate its effectiveness in clinical use. The alarm device is mainly composed of buzzer, indicator light, magnetic sheet. This is a prospective randomized and controlled study. Four hundred patients who met the inclusion/exclusion criteria were included and randomly assigned to two groups (MCD group vs alarm + MCD group). The primary outcome measures were the sensitivity and specificity of the alarm device to detect MCD displacement, time to hemostasis (TTH), time to ambulation (TTA), time to hospital discharge (TTHD), hospital costs (HC), complication rates, and patient satisfaction. The sensitivity and specificity of the alarm device in detecting MCD displacement were 94.44% and 88.46%, respectively. The study group achieved shorter TTH (p =.034), shorter TTA (p =.021), lower complication rates (p =.025), and better patients' satisfaction (p <.001) compared to the control group. However, no significant difference was observed in TTHD (p =.361) and HC (p =.583). The alarm device is highly sensitive in detecting MCD displacement, while achieving better clinical outcomes compared with artificial monitoring. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to assess the clinical outcome of percutaneous kyphoplasty (PKP) assisted with mixed reality (MR) technology in treatment of osteoporotic vertebral compression fracture (OVCF) with intravertebral vacuum cleft (IVC). Method: Forty cases of OVCF with IVC undergoing PKP were randomized into a MR technology-assisted group (group A) and a traditional C-arm fluoroscopy group (group B). Both groups were performed PKP and evaluated by VAS scores, ODI scores, radiological evidence of vertebral body height, and kyphotic angle (KA) at pre-operation and post-operation. The volume of injected cement, fluoroscopy times, and operation time were recorded. And cases of non-PMMA-endplates-contact(NPEC) in radiological evidence was also recorded postoperatively. The clinical outcomes and complications were evaluated afterwards. All patients received 10 to 14 months follow-up, with an average of 12 months. Result: This MR-assisted group (group A) acquired more about the amount of the polymethyl methacrylate (PMMA) injection and postoperative vertebral height and less about postoperative KA, fluoroscopy times, and operation time compared with the control group (group B) (P < 0.05). The VAS scores and ODI scores in both groups have improved, but more significantly in group A (P < 0.05). Also, more cases achieve both-endplates-touching of cement in group A (P < 0.05). And there are less of the loss of vertebral height, KA, and occurrence of re-collapse of the vertebra in group A during the follow-up (P < 0.05). Conclusion: PKP assisted with MR technology can accurately orientate the position of IVC area, which can be augmented by the balloon leading to more satisfied vertebral height improvement, cement diffusion, and pain relief. Trial registration: ClinicalTrials.gov Identifier: NCT03959059. Registered 25 September 2016. [ABSTRACT FROM AUTHOR]