Clinical Improvement and Cost-effectiveness of CT-guided Radiofrequency Sacroplasty (RFS) and Cement Sacroplasty (CSP) – a Prospective Randomised Comparison of Methods

Reimer Andresen; Sebastian Radmer; Julian Ramin Andresen; Mathias Wollny; Urs Nissen; Hans-Christof Schober

doi:10.1055/a-0815-5073

Zeitschrift für Orthopädie und Unfallchirurgie, Table of Contents

Z Orthop Unfall 2019; 157(05): 524-533
DOI: 10.1055/a-0815-5073

Original Article/Originalarbeit

Georg Thieme Verlag KG Stuttgart · New York

Clinical Improvement and Cost-effectiveness of CT-guided Radiofrequency Sacroplasty (RFS) and Cement Sacroplasty (CSP) – a Prospective Randomised Comparison of Methods

Cement Augmentation in Insufficiency Fractures of the Sacral Bone Article in several languages: English | deutsch

Reimer Andresen

¹Institut für Diagnostische und Interventionelle Radiologie/Neuroradiologie, Westküstenklinikum Heide, Akademisches Lehrkrankenhaus der Universitäten Kiel, Lübeck und Hamburg

,

Sebastian Radmer

²Facharztpraxis für Orthopädie, Zentrum für Bewegungsheilkunde, Berlin

,

Julian Ramin Andresen

³Medizinische Fakultät, Sigmund Freud PrivatUniversität, Wien, Österreich

,

Mathias Wollny

⁴Reimbursement, Medimbursement, Tarmstedt

,

Urs Nissen

⁵Klinik für Neurochirurgie und Wirbelsäulenchirurgie, Westküstenklinikum Heide, Akademisches Lehrkrankenhaus der Universitäten Kiel, Lübeck und Hamburg

,

Hans-Christof Schober

⁶Klinik für Innere Medizin I, Klinikum Südstadt Rostock, Akademisches Lehrkrankenhaus der Universität Rostock

› Author Affiliations

Abstract

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 patientsʼ 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.

Key words

insufficiency fracture - sacrum - radiofrequency sacroplasty - pain therapy - cement sacroplasty

Full Text

References

References/Literatur
1 Lourie H. Spontaneous osteoporotic fracture of the sacrum. An unrecognised syndrome of the elderly. JAMA 1982; 248: 715-717
2 Wagner D, Ossendorf C, Gruszka D. et al. Fragility fractures of the sacrum: how to identify and when to treat surgically?. Eur J Trauma Emerg Surg 2015; 41: 349-362
3 Lyders EM, Whitlow CT, Baker MD. et al. Imaging and treatment of sacral insufficiency fractures. AJNR Am J Neuroradiol 2010; 31: 201-210
4 Nüchtern JV, Hartel MJ, Henes FO. et al. Significance of clinical examination, CT and MRI scan in the diagnosis of posterior pelvic ring fractures. Injury 2015; 46: 315-319
5 Schindler OS, Watura R, Cobby M. Sacral insufficiency fractures. J Orthop Surg (Hong Kong) 2007; 15: 339-346
6 Aretxabala I, Fraiz E, Perez-Ruiz F. et al. Sacral insufficiency fractures. High association with pubic rami fractures. Clin Rheumatol 2000; 19: 399-401
7 Alnaib M, Waters S, Shanshal Y. et al. Combined pubic rami and sacral osteoporotic fractures: a prospective study. J Orthop Traumatol 2012; 13: 97-103
8 Grasland A, Pouchot J, Mathieu A. et al. Sacral insufficiency fractures: an easily overlooked cause of back pain in elderly women. Arch Intern Med 1996; 156: 668-674
9 Dasgupta B, Shah N, Brown H. et al. Sacral insufficiency fractures: an unsuspected cause of low back pain. Br J Rheumatol 1998; 37: 789-793
10 Babayev M, Lachmann E, Nagler W. The controversy surrounding sacral insufficiency fractures: to ambulate or not to ambulate?. Am J Phys Med Rehabil 2000; 79: 404-409
11 Andresen R, Radmer S, Lüdtke CW. et al. [Conservative therapy versus CT guided balloon sacroplasty in the treatment of insufficiency fractures of the sacrum]. Osteologie/Osteology 2015; 24: 92-98
12 Tjardes T, Paffrath T, Baethis H. et al. Computer assisted percutaneous placement of augmented iliosacral screws. Spine (Phila Pa 1976) 2008; 33: 1497-1500
13 Klineberg E, McHenry T, Bellabarba C. et al. Sacral insufficiency fractures caudal to instrumented posterior lumbosacral arthrodesis. Spine (Phila Pa 1976) 2008; 33: 1806-1811
14 Josten C, Höch A. [Fractures of the sacrum: operative/conservative]. Die Wirbelsäule 2017; 1: 31-40
15 Butler CL, Given 2nd CA, Michel SJ. et al. Percutaneous sacroplasty for the treatment of sacral insufficiency fractures. AJR Am J Roentgenol 2005; 184: 1956-1959
16 Heron J, Connell DA, James SL. CT-guided sacroplasty for the treatment of sacral insufficiency fractures. Clin Radiol 2007; 62: 1094-1100
17 Frey ME, DePalme MJ, Cifu DX. et al. Percutaneous sacroplasty for osteoporotic sacral insufficiency fractures: a prospective, multicenter, observational pilot study. Spine (Phila Pa 1976) 2008; 8: 367-373
18 Bayley E, Srinivas S, Boszczyk BM. Clinical outcomes of sacroplasty in sacral insufficiency fractures: a review of the literature. Eur Spine J 2009; 18: 1266-1271
19 Andresen R, Radmer S, Kamusella P. et al. [Interventional pain relief using balloon-kyphoplasty in patients with osteoporotic-based fatigue fractures of the os sacrum]. Rofo 2012; 184: 32-36
20 Talmadge J, Smith K, Dykes T. et al. Clinical impact of sacroplasty on patient mobility. J Vasc Interv Radiol 2014; 25: 911-915
21 Onen MR, Yuvruk E, Naderi S. Reliability and effectiveness of percutaneous sacroplasty in sacral insufficiency fractures. J Clin Neurosci 2015; 22: 1601-1608
22 Andresen R, Radmer S, Wollny M. et al. [CT-guided balloon sacroplasty (BSP), radiofrequency sacroplasty (RFS), vertebrosacroplasty (VSP) and cement sacroplasty (CSP) in non-dislocated insufficiency fractures – a comparison of methods with regard to outcome, costs and reimbursement]. Die Wirbelsäule 2018; 2: 75-84
23 Rommens PM, Hofmann A. Comprehensive classification of fragility fractures of the pelvic ring: recommendations for surgical treatment. Injury 2013; 44: 1733-1744
24 Pfeilschifter J, Baum E, Braun J. et al. DVO guideline 2009 for prevention, diagnosis and therapy of osteoporosis in adults. Osteologie/Osteology 2011; 20: 55-74
25 Denis F, Davis S, Comfort T. Sacral fractures: an important problem. Retrospective analysis of 236 cases. Clin Orthop Relat Res 1988; 227: 67-81
26 Andresen R, Radmer S, Kamusella P. et al. Treatment of Denis 1, 2 and 3 insufficiency fracture zones of the os sacrum. Individual approaches adapted to the course of the fracture in CT-assisted balloon sacroplasty. Osteologie/Osteology 2012; 21: 168-173
27 Lübke N, Meinck M, von Renteln-Kruse W. [The Barthel Index in geriatrics. A context analysis for the Hamburg Classification Manual]. Z Gerontol Geriatr 2004; 37: 316-326
28 Institut für das Entgeltsystem im Krankenhaus (InEK). G-DRG Report-Browser für HA V2015/2017. Im Internet: http://www.g-drg.de/G-DRG-System_2017/Abschlussbericht_zur_Weiterentwicklung_des_G-DRG-Systems_und_Report_Browser/Report-Browser_2017 Stand: 15.03.2018
29 Institut für das Entgeltsystem im Krankenhaus (InEK). Kalkulation von Fallkosten. Handbuch zur Anwendung in Krankenhäusern. Version 3.0, 2007, DKVG mbH. Im Internet: http://www.g-drg.de/Kalkulation2/DRG-Fallpauschalen_17b_KHG/Kalkulationshandbuch Stand: 03.10.2016
30 Statistisches Bundesamt. Stationäre Krankenhauskosten 2015 auf 84,2 Milliarden Euro gestiegen. Pressemitteilung Dezember 2016-464/16. Im Internet: https://www.destatis.de/DE/PresseService/Presse/Pressemitteilungen/2016/12/PD16_464_231.html Stand: 22.12.2016
31 Garant M. Sacroplasty: a new treatment for sacral insufficiency fracture. J Vasc Interv Radiol 2002; 13: 1265-1267
32 Bastian JD, Keel MJ, Heini PF. et al. Complications related to cement leakage in sacroplasty. Acta Orthop Belg 2012; 78: 100-105
33 Andresen R, Radmer S, Wollny M. et al. CT-guided cement sacroplasty (CSP) as pain therapy in non-dislocated insufficiency fractures. Eur J Orthop Surg Traumatol 2017; 27: 1045-1050
34 Prokop A, Andresen R, Chmielnicki M. [Balloonsacroplasty: C-arm or CT controlled application?: Experience with 46 patients]. Unfallchirurg 2016; 119: 929-935
35 Andresen R, Lüdtke CW, Radmer S. et al. Radiofrequency sacroplasty (RFS) for the treatment of osteoporotic insufficiency fractures. Eur Spine J 2015; 24: 759-763
36 Eichler K, Zangos S, Mack MG. et al. Outcome of long-axis percutaneous sacroplasty for the treatment of sacral insufficiency fractures with a radiofrequency-induced, high-viscosity bone cement. Skeletal Radiol 2014; 43: 493-498
37 Yang SC, Tsai TT, Chen HS. et al. Comparison of sacroplasty with or without balloon assistance for the treatment of sacral insufficiency fractures. J Orthop Surg (Hong Kong) 2018; 26: 1-8
38 Andresen R, Radmer S, Andresen JR. et al. Comparison of the 18 months outcome after the treatment of osteoporotic insufficiency fractures by means of balloon sacroplasty (BSP) and radiofrequency sacroplasty (RFS) in comparison: a prospective randomised study. Eur Spine J 2017; 26: 3235-3240
39 Richards AM, Mears SC, Knight TA. et al. Biomechanical analysis of sacroplasty: does volume or loacation of cement matter?. AJNR Am J Neuroradiol 2009; 30: 315-317
40 Trouvin AP, Alcaix D, Somon T. et al. Analgesic effect of sacroplasty in osteoporotic sacral fractures: a study of six cases. Joint Bone Spine 2012; 79: 500-503
41 Andresen R, Radmer S, Banzer D. Bone mineral density and spongiosa architecture in correlation to vertebral body insufficiency fractures. Acta Radiol 1998; 39: 538-542
42 Krüger A, Wollny M, Oberkircher L. et al. [Revenue and losses with vertebral augmentation under the G-DRG system 2012 – a comparison of supply costs in the context of vertebroplasty and kyphoplasty]. Z Orthop Unfall 2012; 150: 539-546
43 Krüger A, Oberkircher L, Ruchholtz S. et al. [Reimbursement for kyphoplasty in the German diagnosis-related groups system 2011/2012. Material costs versus treatment costs]. Unfallchirurg 2014; 117: 54-59