Radiofrequenz-Kyphoplastie – ein neues Verfahren zur Augmentation von osteoporotischen Wirbelkörperfrakturen

Zusammenfassung

Einleitung: Die Radiofrequenz (RF)-Kyphoplastie ist ein neues Verfahren zur Augmentation von osteoporotischen Wirbelkörperfrakturen. Osteoplastische Verfahren der Wirbelsäule erlauben die mechanische Stabilisierung der frakturierten Wirbelkörper durch Knochenzement und reduzieren dadurch den Schmerz. Die Hauptkomplikationen dieser minimal invasiven Verfahren sind die Zementaustritte in das umgebende Gewebe, in den Spinalkanal und in die Gefäße. Diese werden für die Vertebroplastie in guten Studien bis zu 72 % und bei der Ballon-Kyphoplastie bis 27 % beschrieben. Der Hintergrund der vorliegenden Studie war es, das neue RF-Kyphoplastie-Verfahrens bei Neuanwendern zu evaluieren.

Patienten, Material und Methoden: Die ersten 20 RF-Kyphoplastien in den sieben verschiedenen Zentren in Deutschland und der Schweiz wurden in die Beobachtungsstudie mit einbezogen. Nach jeder Anwendung der RF-Kyphoplastie bearbeiteten die Chirurgen einen weitreichenden Fragebogen und stellten die Röntgenbilder zur Verfügung. Die Dokumentation beinhaltete Informationenüber die Grunderkrankung, die Höhe der Fraktur, den Zugang zum Wirbelkörper, das Alter der Fraktur, das applizierte Volumen, und Zementaustritte. Alle Dokumentationen wurden von einem unabhängigen Auswerter kontrolliert und die Röntgenbilder in Bezug auf den Schweregrad und die Zementaustritte ausgewertet. In den sieben Zentren wurden 138 Patienten in die Studie aufgenommen. Die Ursache für die Wirbelkörperfrakturen waren Osteoporose, sekundäre Osteoporose und maligne Erkrankungen des Knochens.

Ergebnisse: Von den 186 behandelten Wirbelkörpern wurden 73 % auf einer Höhe versorgt, 20 % auf zwei Höhen, 6 % auf drei Höhen und 1 % auf vier Höhen. Der gewählte Zugang war in 95 % unipedikulär. Zementaustritte wurden in 15,5 % auf den Röntgenbildern gefunden, aber ohne (0 %) klinische Komplikationen. Bei allen Patienten wurde eine signifikante Verbesserung der Zufriedenheit und der Funktion kurz nach der Intervention beschrieben. Minimal invasive perkutane Osteoplastie ist ein Standard der schmerzhaften osteoporotischen Kompressionsfrakturen. Die Ergebnisse der vorliegenden Studie zeigen, dass die RF-Kyphoplastie mit hoch viskösem Knochenzement als sicheres Verfahren für den Patienten und den Anwender betrachtet werden kann. Zementaustritte waren geringer als in den randomisierten prospektiven Studien zur Vertebroplastie und Ballon-Kyphoplastie.

Schlussfolgerung: Das lässt die Schlussfolgerung zu, das selbst in Händen von neuen Anwendern des Verfahrens, nach einem Training, eine hohe Sicherheit für den Patienten und eine problemloses Handling für den Chirurgen besteht.

Summary

Introduction: Radiofrequency Kyphoplasty (RFK) is a novel vertebral augmentation procedure that consists of non-balloon, targeted delivery of an ultra-high viscosity cement. The most likely mechanism for pain relief after osteoplasty of fractured vertebral bodies is the mechanical stabilization of the vertebral body. The main risk of these minimally invasive techniques is leakage of PMMA into the venous system, reported to be as high as 72 % and 27 % in large prospective randomized trials of vertebroplasty and balloon kyphoplasty, respectively. The purpose of the present study was to evaluate the novel device usability and procedural adaptation with observational evaluation of procedural and short term clinical outcomes.

Methods: The first 20 RFK cases performed at six German centers and one Swiss center were enrolled in this observational study. Following each case, physicians completed extensive questionnaires and provided pre-and postoperative radiographs that documented pro-cedural and clinical detail of each RFK procedure. The questionnaire consisted of questions about the underlying cause of the vcfs, site of the procedure, the approach, the estimated age of the fracture, cement volume delivered per level, cement extravasation, height restoration, improvement of the patient, and satisfaction of the surgeon. All report forms and preoperative and postoperative x-rays were independently analyzed by a third reader.

Results: In seven centers 138 patients were enrolled into the observational study. The underlying cause of the fracture was postmenopausal or secondary osteoporosis, and malignant bone diseases of the spine. Of the 186 vertebral bodies augmented, 101 patients (73 %) were treated for one level, 27 (20 %) for two levels, 9 (6 %) for 3 levels and 1 (1 %) for 4 levels. All multiple levels interventions were performed in the same procedure. The approach to the spine was unipediculate in 95 % and bipedicular in 5 %. There was no evidence of clinical complications and only one technical complication (0.7 %) of the device. Cement extravasation (after re-evaluation of the x-rays) was found in 15,5 % of all cases, but no clinical significant complication was reported (0 %). In all patients was an improvement of the patient’s satisfaction and function in the short term after the intervention documented.

Conclusion: Minimal-invasive, percutaneous osteoplasty has become a standard for the treatment of painful osteoporotic vertebral compression fractures and bone metastases of the spine. The results of the observational series presented, demonstrate that RF-kyphoplasty with high-viscosity cement application can be considered a safe procedure, if performed in a hospital-based setting. The cement leakage rate was lower than those reported in large prospective clinical studies for both vertebroplasty and balloon kyphoplasty. This suggests that even after minimal initial training this procedure can be performed with a good degree of safety for the patient and convenience for the surgeon.

Schlüsselwörter

Radiofrequenz-Kyphoplastie - vertebrale Augmentation - hoch visköser Knochenzement

Keywords

Radiofrequency Kyphoplasty - vertebral augmentation procedure - ultra-high viscosity cement

• References

• 1 Black DM, Palermo L, Nevitt MC. et al. The Study of Osteoporotic Fractures Research Group. Defining incident vertebral deformity: a prospective comparison of several approaches. J Bone Miner Res 1999; 14: 90-101.
• 2 Möller G, Andresen R, Banzer D. Shape modelbased semi-automatic morphometric assessment of vertebral deformities in clinical practice results of a multi-center medical practice evaluation pilot study in Germany. Osteologie/Osteology 2011; 20: 239-247.
• 3 Steinleitner WE, Thuro HC, Schöffel D. Schmerzen bei Osteoporose – die schmerzhafte osteoporotische Wirbelkörperfraktur. Osteologie 2008; 17: 195-199.
• 4 Hadji P. et al. Presented at the Osteologie Kongress, Basel. 2012
• 5 THE EUROPEAN PROSPECTIVE OSTEOPOROSIS STUDY (EPOS) GROUP. Incidence of Vertebral Fracture in Europe: Results From the European Prospective Osteoporosis Study (EPOS). Journal of Bone and Mineral Research 2002; 17: 716-724.
• 6 Peh WC, Munk PL, Rashid F, Gilula LA. Percutaneous vertebral augmentation: vertebroplasty, kyphoplasty and skyphoplasty. Radiol Clin North Am 2008; 46: 611-635.
• 7 Gangi A, Sabharwal T, Irani FG. et al. Standards of Practice Committee of the Society of Interventional Radiology. Quality assurance guidelines for percutaneous vertebroplasty. Cardiovasc Intervent Radiol 2006; 29: 173-178.
• 8 Haas H, Amling M, Baier M. et al. Zur Anwendung der Ballon-Kyphoplastie/Vertebroplastie. Osteologie 2008; 17: 11-16.
• 9 McGraw JK, Lippert JA, Minkus KD. et al. Prospective evaluation of pain relief in 100 patients undergoing percutaneous vertebroplasty: results and follow-up. J Vasc Interv Radiol 2002; 13: 883-886.
• 10 Liu JT, Liao WJ, Tan WC. et al. Balloon kyphoplasty versus vertebroplasty for treatment of osteoporotic vertebral compression fracture: a prospective, comparative, and randomized clinical study. Osteoporos Int 2010; 21: 359-364.
• 11 Bornemann R, Hanna M, Kabir K. et al. Continuing conservative care versus crossover to radiofrequency kyphoplasty: a comparative effectiveness study on the treatment of vertebral body fractures. Eur Spine J 2012; 21: 930-936.
• 12 Taylor RS, Taylor RJ, Fritzell P. Balloon kyphoplasty and vertebroplasty for vertebral compression fractures: a comparative systematic review of efficacy and safety. Spine (Phila Pa 1976) 2006; 31: 2747-2755.
• 13 Klazen CAH, Lohle PNM, de Vries J. et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomized trial. Lancet 2010; 376: 1031-1033.
• 14 Wardlaw D, Cummings SR, Van Meirhaeghe J. et al. Efficacy and safety of balloon kyphoplasty compared with non-surgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet 2009; 373: 1016-1024.
• 15 Hochmuth K, Proschek D, Schwarz W. et al. Percutaneous vertebroplasty in the therapy of osteoporotic vertebral compression fractures: a critical review. Eur Radiol 2006; 16: 998-1004.
• 16 Pflugmacher R, Bornemann R, Koch ME. et al. Comparison of clinical and radiological data in the treatment of patients with osteoporotic vertebral compression fractures using radiofrequency kyp hoplasty or balloon kyphoplasty. Z Orthop Unfall 2012; 150: 56-61.
• 17 Lenchik L, Rogers LF, Delmas PD, Genant HK. Diagnosis of osteoporotic vertebral fractures: importance of recognition and description by radiologists. Am J Roentgenol 2004; 183: 949-958.
• 18 Deramond H, Depriester C, Toussaint P, Galibert P. Percutaneous vertebroplasty. Semin Musculoskelet Radiol 1997; 1: 285-296.
• 19 McGraw JK, Cardella J, Barr JD. et al SIR Standards of Practice Committee. Society of Interventional Radiology quality improvement guidelines for percutaneous vertebroplasty. J Vasc Interv Radiol 2003; 14: 827-831.
• 20 Nussbaum DA, Gailloud P, Murphy K. A review of complications associated with vertebroplasty and kyphoplasty as reported to the Food and Drug Administration medical device related web site. J Vasc Interv Radiol 2004; 15: 1185-1192.
• 21 Yeom JS, Kim WJ, Choy WS. et al. Leakage of cement in percutaneous transpedicular vertebroplasty for painful osteoporotic compression fractures. J Bone Joint Surg (Br) 2003; 85: 83-89.
• 22 Gangi A, Wong L, Guth S, Dietermann J. Percutaneous vertebroplasty: indications, technique, and results. Semin Intervent Radiol 2002; 19: 265-270.
• 23 Heran MK, Legiehn GM, Munk PL. Current concepts and techniques in percutaneous vertebroplasty. Orthop Clin North Am 2006; 37: 409-434.
• 24 Gangi A, Guth S, Imbert JP. et al. Percutaneous vertebroplasty: indications, technique, and results. Radiographics 2003; 23: e10.
• 25 Padovani B, Kasriel O, Brunner P, Peretti-Viton P. Pulmonary embolism caused by acrylic cement: a rare complication of percutaneous vertebroplasty. Am J Neuroradiol 1999; 20: 375-377.
• 26 Choe DH, Marom EM, Ahrar K. et al. Pulmonary embolism of polymethyl methacrylate during percutaneous vertebroplasty and kyphoplasty. Am J Roentgenol 2004; 183: 1097-1102.
• 27 Lin EP, Ekholm S, Hiwatashi A, Westesson PL. Vertebroplasty: cement leakage into the disc increases the risk of new fracture of adjacent vertebral body. Am J Neuroradiol 2004; 25: 175-180.