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Introduction: The objective of this study was a comparative analysis of cement augmentation by means of RFS and CSP with regard to outcome and cost-effectiveness., Patients and Methods: CT-guided cement augmentation was performed on 100 patients with a total of 168 non-dislocated insufficiency fractures, 50 patients being treated with RFS and 50 patients with CSP. Leakages were detected by CT. Pain intensity was determined on a VAS before and after the intervention. The patients' self-sufficiency was assessed using the Barthel index. Patients were asked about any complications and their level of satisfaction. Costs incurred for carrying out the procedure were compared with the respective reimbursements received., Results: Both procedures were technically fully feasible. No leakages were found in the RFS group, as opposed to 8.1% asymptomatic leakages in the CSP group. The mean value for pain before intervention was 8.8 in the RFS group and 8.7 in the CSP group. On the second postoperative day, there was a significant pain reduction with a value of 2.4 for both groups, which remained more or less constant over the follow-up period. The Barthel index increased significantly from an average of 30 before the intervention to 80 on the fourth postoperative day and 70 after 24 months. No differences were found between the two procedures with regard to pain, improvement in functional status and satisfaction. Taking into account the state-wide base rate used for calculating reimbursement, 3,834.75 € remained for RFS and 5,084.32 € for CSP., Conclusion: RFS and CSP are minimally invasive procedures that achieve equally good and sustained pain reduction, leading to markedly improved self-sufficiency of the patients. With regard to possible cement leakages, RFS is the safer method. A profit can be generated with both techniques., Competing Interests: Prof. Reimer Andresen MD, Dr. Sebastian Radmer, Julian Ramin Andresen, Dr. Urs Nissen and Prof. Hans Christof Schober have no conflict of interest. Mathias Wollny was Director for Reimbursement and Marketing Europe in the firm DFINE Europe GmbH (now Merit Medical) in Mannheim Germany till November 2016./Prof. Dr. Reimer Andresen, Dr. Sebastian Radmer, Julian Ramin Andresen, Dr. Urs Nissen und Prof. Dr. Hans-Christof Schober haben keinen Interessenkonflikt. Mathias Wollny war Direktor für Reimbursement & Marketing Europe der Firma DFINE Europe GmbH (heute Merit Medical), Mannheim, Deutschland bis November 2016., (Georg Thieme Verlag KG Stuttgart · New York.)

Introduction: In elderly patients with reduced bone quality, insufficiency fractures of the sacrum are relatively common and are typically associated with severe disabling pain. The objective of the present study was to examine the feasibility of cement augmentation by CSP, to determine post-interventional leakages and other complications, and to present the outcome of pain over the course of 18 months., Materials and Methods: In 23 patients (20 women and 3 men) with an average age of 81.3 (71-92) years, a total of 41 sacral fractures were detected by MRI, 5 of them unilateral and 18 bilateral. Conservative treatment initially performed over a period of 3 weeks did not bring any satisfactory reduction in the severe disabling pain. The indication for intervention was established after an interdisciplinary case conference. The intervention was performed under intubation anaesthesia. Single-shot antibiotic prophylaxis was given routinely immediately prior to the intervention. Under sterile conditions, a Jamshidi needle was then advanced into the respective fracture zone in the sacrum from dorsal to ventral (short axis) or from lateral to medial transiliac (transiliac axis). After removing the inner needle, a flexible osteotome was inserted through the positioned hollow needle and used to extend the spongious space in the fracture zone and thus prepare a cavity for the cement filling. High-viscosity PMMA cement was then inserted discontinuously with the aid of a pressure gauge under low-dose CT control. Cement leakages were determined in the CT image on the day after the intervention, all cement outside of the cortical boundary being rated as a leakage. Pain was documented on a visual analogue scale (VAS) on the day before the intervention, on the second day, and 6, 12, and 18 months after the intervention. Additionally occurring complications were recorded, and the patients were asked to rate their satisfaction after 6 and 18 months., Results: CSP was technically feasible in all patients. In the control CT scan, sufficient cement distribution and interlocking with vital bone were found along the course of the fracture in the sacrum. An average of 6.0 ± 0.83 ml of cement was inserted per fracture. Leakage was found in 5 of 41 (12.2%) of the fractures treated, although none were symptomatic. The mean pain score on the VAS was 8.8 ± 0.59 before the intervention, a significant pain reduction (p < 0.0005) was seen on the second post-operative day, with an average value of 2.1 ± 0.36, and this was stable at 2.2 ± 0.28 after 6, 2.3 ± 0.31 after 12, and 2.2 ± 0.41 after 18 months. Now that they no longer experienced disabling pain, all of the patients were fully remobilised and discharged back home. A high level of patient satisfaction was found after 6 and 18 months., Conclusion: As a minimally invasive procedure, CSP is an effective treatment method for rapid, significant, and sustained pain reduction.

Purpose: The objective of this prospective, randomised study was to examine the feasibility and clinical outcome of balloon sacroplasty and radiofrequency sacroplasty., Methods: In 40 patients with a total of 57 sacral fractures, CT-guided cement augmentation was performed by means of BSP or RFS. For BSP, the balloon catheter was inflated and deflated in the fracture zone, and the hollow space, thus, created was then filled with PMMA cement. For RFS, the spongious space in the fracture zone was initially extended using a flexible osteotome, and the highly viscous PMMA cement, activated by radiofrequency, was then inserted into the prepared fracture zone. Pain intensity was determined on a VAS before the intervention, on the second day, and 6, 12 and 18 months after the intervention. The results were tested for significance by means of paired Wilcoxon rank-sum tests and Mann-Whitney U tests., Results: BSP and RFS were technically fully feasible in all patients. An average of 6.3 ml cement per fracture was inserted in the BSP group and an average of 6.1 ml per fracture in the RFS group. Leakage could be ruled out for both procedures. The mean pain score on the VAS before the intervention was 8.6 ± 0.55 in the BSP group and 8.8 ± 0.58 in the RFS group. On the second postoperative day, a significant pain reduction was seen (p < 0.001), with an average value of 2.5 (BSP ± 0.28, RFS ± 0.38) for both groups. After 6 (12; 18) months, these values were stable for the BSP group at 2.3 ± 0.27 (2.3 ± 0.24; 2.0 ± 0.34) and for the RFS group at 2.4 ± 0.34 (2.2 ± 0.26; 2.0 ± 0.31). With regard to pain, exceedance probability values of p = 0.86 (6 months), p = 0.94 (12 months) and p = 1 (18 months) were seen, so that neither treatment method leads to differences in results., Conclusions: BSP and RFS are interventional, minimally invasive procedures that enable reliable cement augmentation and achieve equally good clinical outcomes in the medium term.

Introduction and Objective: In elderly patients with reduced bone quality, insufficiency fractures of the sacrum are relatively common and are typically accompanied by severe, disabling pain. The objective of this study was to evaluate the feasibility of cement augmentation by RFS, as well as to determine postinterventional leakages and present the patients' outcomes., Material and Method: In 20 patients (18 women, 2 men) with an average age of 80.4 (65-92) years, a fracture of the sacrum was detected by CT and MRI. Clinically manifest osteoporosis with QCT values of below 50 mg/ml was found in all patients. An initially performed conservative treatment over a period of 3 weeks did not achieve a satisfactory reduction in the severe, disabling pain. The cement augmentation was performed under CT guidance by means of RFS under intubation anaesthesia. A Jamshidi needle was advanced into the respective fracture zone in the sacrum from dorsal to ventral (short axis) or from lateral to medial transiliac (transiliac axis). After removing the inner needle, a flexible osteotome was inserted through the positioned hollow needle and used to extend the spongious space in the fracture zone and thus prepare a cavity for the cement filling. The highly viscous polymethyl methacrylate (PMMA) cement, activated by radiofrequency, was then inserted into the prepared fracture zone through a substituted screw cannula. Cement filling was performed discontinuously under instrumental guidance at 1.3 ml/min under CT guidance. Cement leakages were determined in CT images and conventional X-rays on the day after the intervention. Pain was documented on a visual analogue scale (VAS) on the day before the intervention, on the second day, and after 6 and 12 months after the intervention. Additionally occurring complications were recorded, and the patients were asked to state how satisfied they were after 12 months., Results: RFS was technically feasible in all patients. In the control CT scans and X-rays, sufficient cement distribution and interlocking with vital bone was found along the course of the fracture in the sacrum. 7.2 (4-9) ml of cement were inserted per fracture. Leakage could be ruled out. The mean pain score on the VAS was 8.8 ± 1.2 before the intervention, and a significant reduction in pain (p < 0.001) was seen on the second postoperative day, with an average value of 2.3 ± 0.7, which was stable at 2.2 ± 1.3 after 6 months and 2.1 ± 1.1 after 12 months. All of the patients could be fully re-mobilised and discharged back home. A high level of patient satisfaction was found after 12 months, with 18 of the 20 patients stating that they would undergo the intervention again. One patient died of a stroke, another of cancer over the course., Conclusion: As a minimally invasive procedure, RFS is an effective and safe method of treatment for rapid, significant and sustained pain reduction.