Journal of Korean Society of Spine Surgery Percutaneous Vertebral Augmentation for the Treatment of Osteoporotic Spinal Fractures Young-Woo Kim, M.D.,

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1 Journal of Korean Society of Spine Surgery Percutaneous Vertebral Augmentation for the Treatment of Osteoporotic Spinal Fractures Young-Woo Kim, M.D., Ph.D., Jong-Mun Ha, M.D., Koo-Hyun Jung, M.D. J Korean Soc Spine Surg 2015 Dec;22(4): Originally published online December 31, 2015; Korean Society of Spine Surgery Department of Orthopedic Surgery, Gangnam Severance Spine Hospital, Yonsei University College of Medicine, 211 Eunju-ro, Gangnam-gu, Seoul, 06273, Korea Tel: Fax: Copyright 2015 Korean Society of Spine Surgery pissn eissn The online version of this article, along with updated information and services, is located on the World Wide Web at: This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

2 Review Article pissn eissn J Korean Soc Spine Surg Dec;22(4): Percutaneous Vertebral Augmentation for the Treatment of Osteoporotic Spinal Fractures Young-Woo Kim, M.D., Ph.D., Jong-Mun Ha, M.D., Koo-Hyun Jung, M.D. Department of Orthopedic Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-Do, Korea Study Design: Review of the literature. Objectives: To present updated information on percutaneous vertebral augmentation (PVA) for osteoporotic spinal fractures (OSFs). Summary of Literature Review: Vertebroplasty and kyphoplasty have been used to treat osteoporotic spinal fractures for many years. A recent meta-analysis provides strong evidence in favor of cement augmentation in the treatment of symptomatic vertebral compression fractures. Materials and Methods: Review of the relevant literature. Results: A meta-analysis showed greater pain relief, functional recovery, and improvement in quality of life with cement augmentation compared with control subjects. Conclusions: Percutaneous vertebral augmentation of osteoporotic spinal fractures results in shorter hospital stays, reduced incidence of complications, and more rapid return of functional independence. Key Words: Osteoporotic spinal fractures, Surgical treatment, Percutaneous vertebral augmentation 서론 골다공증성척추골절 (osteoporotic spinal fractures, OSFs) 이발생하면사용할수있는치료방법이많지않은데, 침상안정및보조기와진통제등의약물을사용하여전통적인보존적가료를시행하거나, 골절된척추체에골시멘트를주입하는경피적척추보강술 (percutaneous vertebral augmentation, PVA) 을시행하거나, 골절부위를절개하여신경을감압하고골절된척추를고정하는관혈적수술등의방법을사용할수있다 년미국정형외과학회 (American Academy of Orthopaedic Surgeons, AAOS) 는골다공증성척추골절에대한치료지침을발표하면서척추성형술 (vertebroplasty) 은시행하지말것을강력하게권고하였고, 풍선성형술 (kyphoplasty) 은통증이동반될경우에사용될수있는치료방법이라고하였다. 1) 하지만 2014 년에는 8개의신경외과와영상의학과관련단체들이모여보존적인치료에반응하지않는통증을동반한골다공증성척추골절에대한경피적척추보강술은의학적으로증명된적절한치료방법이라고공식적인입장을천명하였다. 2) 본론 1. 경피적척추보강술의적응증및금기증 가장흔한적응증은보존적치료에반응하지않는통증을동 반한골다공증성척추골절이다. 다른적응증으로는광범위한혈 관종이나거대세포종, 병적골절을동반한골용해성전이암등 이있을수있고 Kümmell 병으로알려져있는골다공증성척추 골절의통증성불유합에도사용될수있다. 3) 금기증으로는증상이없거나보존적가료로증상이회복되는 Received: November 18, 2015 Revised: December 1, 2015 Accepted: December 21, 2015 Published Online: December 31, 2015 Corresponding author: Young-Woo Kim, M.D., Ph.D. Department of Orthopedic Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Gyeonggi-Do, Korea 40, Sukwoo-Dong, Hwaseong-Si, Gyeonggi-Do, , Korea TEL: , FAX: ywkimmd@gmail.com 192 Copyright 2015 Korean Society of Spine Surgery

3 Journal of Korean Society of Spine Surgery Percutaneous Vertebral Augmentation 골절, 척추에골수염병력이있는경우, 골시멘트나조영제에대한과민반응이있을경우, 교정되지않은혈액응고장애, 종양에의한병적골절이척수를압박하고있는경우등이다. 3) 2. 경피적척추보강술의시행시기골절의급성기인수상후 2-3주내에조기시술을할경우시행하지않아도되는환자에게불필요하게시술하게되는경우가늘어난다. 4) 반대로수상후 2-3개월이후에지연시술을할경우환자에게오랜기간고통과움직임에제한을주고만족스럽지않은시술결과를낳게된다. 따라서대부분의학자들은경피적척추보강술을하기전에 2-6주간의보존적가료를권유하고있다. 5) 하지만방출성골절이거나, 척추체의압박이심한경우, 흉요추이행부에골절이있는경우에는조기시술을권유하기도한다. 6) 3. 경피적척추보강술의임상적결과역사적으로골다공증성척추골절환자에대한관혈적수술치료는합병증의발생률이높기때문에신경학적결손이있거나불안정성골절이있는환자에게만제한적으로시행되어왔다. 하지만풍선성형술이나척추성형술같은경피적척추보강술이도입되면서골다공증성척추골절환자의치료에있어중요한관점의변화가일어나서, 많은환자들에게수술적치료를시행하게되었다. 지금까지보고된논문을바탕으로분석한경피적척추보강술의임상적결과는다음과같다. 등으로미루어환자를선정하는데문제가있었음을제기하기도 하였다. 23) 2) 척추성형술대비수술적치료 2007 년부터 2014 년까지척추성형술과비수술적치료를비교 4, 9-13) 하는 6편의무작위대조연구가발표되었다. 아급성및만성골다공증성척추골절환자를대상으로한초 기연구 (VERTOS) 에서 Voormolen 등 13) 은 50 세이상을대상으로 18 명은척추성형술로 16 명은비수술적으로치료하였는데, 치료 시작 2 주후비수술적치료군에있던환자의 88% 가척추성형술 군으로이동하였고, 수술후 2 주째시행한삶의질평가에서는 척추성형술군이통계적으로의미있는우수한결과를보였다. 6 주이하의급성골절환자를대상으로한무작위대조연구 (VERTOS II) 에서는 50 세이상의환자중 101 명이척추성형술군 에다른환자 101 명이비수술적치료군에배정되었는데, 치료시 작 1 년후평가에서척추성형술군에서월등하게통증이감소되 었으며삶의질평가점수도빠르게향상되었다. 12) Blasco 등 9) 은한개의기관에서골절이발생된지 12 개월미 만의환자 125 명을대상으로척추성형술 64 명과비수술적치료 61 명으로나누어전향적무작위대조연구결과를발표하였는데 2 개월추시시점에서척추성형술군이월등한통증의감소와삶 의질향상을가져왔으나, 12 개월추시시점에서는두군간에잔 존요통, 삶의질점수, 진통제의사용량등에서통계적으로유의 한차이가없었다. 1) 척추성형술대가장수술 (sham operation) 2009 년 8 월호 NEJM(New England Journal of Medicine) 에 가장수술을대조군으로하여골다공증성척추골절에대한척추 성형술의효과를분석한 2 편의전향적무작위대조연구가발표 되었다. 7,8) 발표된 2 편의논문에서모두가장수술을시행한대조 군과척추성형술을시행한시험군사이에통계적으로의미있 는차이가발견되지않았다고발표하였다. 미국정형외과학회 (American Academy of Orthopaedic Surgeons) 에서는이두편의 논문을근거로골다공증성척추골절의치료에척추성형술을시 행하지말것을강력하게권고하였고미국과몇몇나라의보험 회사에서는척추성형술에대한치료비지급을거부하는사태까 지발생하게되었다. 하지만이두편의논문에대하여북미척추학회 (North American Spine Society) 는몇가지의오류를지적하였는데, 대상환자 를증상발현후 12 개월까지의오래된골절까지포함하였고, 급 성골절에대한명확한정의가없으며, 가장수술을시행할때부 분마취제를주입하였기때문에진정한가장수술이아니며, 참 여가가능했던대상환자의 60% 이상이참여를거절하였던점 3) 풍선성형술대비수술적치료 FREE (Fracture Reduction Evaluation) 연구는급성의증상이있는척추골절환자를 149명의풍선성형술군과 151명의비수술적치료군으로나누어시행한대단위의무작위대조연구이다. 14) 골절발생후연구에참여한시기는풍선성형술군은평균 5.6 주, 비수술적치료군은평균 6.4주였다. 1개월추시시점에서 SF-36 Physical Component Summary 점수가풍선성형술군이비수술적치료군보다 5.2점더증가하였다 (p<0.0001). 하지만이점수의차이는 12개월추시시점에서 1.5점으로감소하였다 (p=0.21). 또한풍선성형술군에서 1개월과 12개월시점의삶의질평가점수가더많이증가되었으며, VAS 점수는 1주시점에는 2.2점이, 12개월시점에서는 0.9점이풍선성형술군에서더감소하였다. 이러한풍선성형술군의우세는 24개월까지지속되었다. 4) 척추성형술대풍선성형술 (Fig. 1) 2010 년이후에골다공증성척추골절에대한척추성형술과풍선성형술을비교하는 2개의무작위대조연구가발표되었는데, Liu 등 15) 은흉요추부 (T12-L1) 에급성기골다공증성척추골절을 193

4 Young-Woo Kim et al Volume 22 Number 4 December 2015 A B C D Fig. 1. A 68-year-old woman experienced multiple osteoporotic spinal fractures after a slip in the bathroom (A). After conservative management for 1 month, she still had severe low back pain. A fat-suppressed T2-weighted mid-sagittal magnetic resonance image shows high signal intensities (arrows) at T11, L1, L2, and L3, which indicates acute fracture (B). Kyphoplasty was performed at L1 and vertebroplasty at T11, L2, and L3 (C). At the 8-month follow-up, the spinal alignment was good, without kyphotic deformity or vertebral body collapse (D). 동반한 100명의환자를척추성형술에 50명, 풍선성형술에 50명을배정하여연구를진행하였다. 6개월간추시한결과요통에대한통증점수가풍선성형술에서 5.4점, 척추성형술에서 5.6점이감소하여통계적으로유의한차이를보이지않았다. 이러한통증의감소는 5년의추시기간동안지속되었다. Dohm 등 16) 은 1-3개의급성골다공증성척추골절환자들을풍선성형술에 191명, 척추성형술에 190명을무작위배정하여비교하였는데 24개월추시시점에서양군모두에서통계적으로의미있는요통의감소를보였고, SF-36 PCS, EQ-5D, ODI 점수가향상되었으며, 마약성진통제의사용이감소되었다. 하지만척추성형술군과풍선성형술군간에통계적으로의미있는차이는없었다. 4. 경피적척추보강술의합병증경피적척추보강술의합병증으로는골시멘트의유출, 색전증, 새로운인접척추체골절의발생등이있다. CT를이용한연구를보면골시멘트의유출이대부분의환자에서 (18-88%) 일어나지만임상적인증상을일으키지는않는다. 17) 시멘트유출의빈도를보면가장흔한부위가추간판내 (45%), 척추체측면 (35%), 경막외공간 (20%), 척추체전방 (18%) 의순으로발생한다. 골시멘트의유출은주입당시골시멘 트의점도가낮을수록, 골절이심할수록, 골시멘트의주입량이많을수록흔하게발생한다. 18) 골시멘트의유출로인한신경학적합병증의발생률은 1% 미만이지만발생하면수술적치료를요하게되며영구적인신경손상을야기하기도한다. 19) 골시멘트의혈관내유출로인한심폐기관의색전증은진단방법에따라 2-26% 로다양하며, 골시멘트뿐만아니라골수내지방도색전증을일으킬수있다. 20) 경피적척추보강술후에골시멘트의주입으로인해척추골의강도가강해져서인접분절로가는부하가커짐에따라새로운골절이야기된다는주장이있다. 하지만척추보강술과비수술적치료를비교한무작위대조연구에대한메타분석을보면척추보강술에의해인접척추체의골절위험도가증가하지않는다고보고되고있다. 21) Zhang 등 22) 은새로운추체골절에대한체계적문헌고찰과메타분석을통해서경피적척추보강술후 21% 의환자에서새로운척추체골절이발생하며골밀도가낮거나, 신체용적지수가낮거나, 추간판내로시멘트의유출이있을경우후속골절의빈도가증가한다고하였다. 5. 경피적척추보강술의수술후처치골다공증성척추골절을당한환자들은합병증을최소화하고신체기능과환자의독립성을최대한유지하기위해서조기에거 194

5 Journal of Korean Society of Spine Surgery Percutaneous Vertebral Augmentation 동을시켜야한다. 경피적척추보강술이후에보조기를착용해야하는가하는문제에있어서는현재까지출판된논문중에서높은근거를제시하는논문은없는실정이다. 하지만골시멘트가골절된척추체를영구적으로고정시킬수없는충전제이고골시멘트로채워진골절부위에계속적으로미세한움직임이일어날경우골유합의지연이나불유합을초래할수있고, 시술부위의진행성압박혹은응고된골시멘트가척추체외부로빠져나가는등의합병증을야기할수있다. 결론 통증을유발하는골다공증성척추골절을당한환자중대부분이행동수정및안정, 진통제, 보조기등의비수술적치료에반응을하지만, 꽤많은수의환자들이이러한비수술적치료요법으로적절한통증완화를얻지못한다. Anderson 등 21) 이시행한메타분석에따르면비수술적치료군에비하여경피적척추보강술을시행받은환자군에서더많은통증의감소와기능적회복과삶의질향상을가져온것으로보고되었다. 척추성형술과풍선성형술간에는증상이없는시멘트의유출을포함하여합병증의발생율이두군간에통계적으로의미있는차이가없는것으로알려졌다. 또한증상이있는골다공증성척추골절치료후에발생하는인접부위척추체의후속골절의경우도척추성형술, 풍선성형술, 비수술적치료군간에발생률에있어서통계적인차이가없는것으로밝혀졌다. 골다공증성척추골절환자를비수술적으로치료했을때유병율과사망률이높은것을감안하고, 지금까지출판된여러편의메타분석과체계적문헌고찰논문을고려했을때, 골다공증성척추골절에대한경피적척추보강술은환자의입원기간을줄여주고합병증을감소시키며신속하게독립적인활동이가능하도록해주는좋은치료방법이라고할수있다. REFERENCES 1. Esses SI, McGuire R, Jenkins J, et al. The treatment of symptomatic osteoporotic spinal compression fractures. J Am Acad Orthop Surg. 2011;19: Barr JD, Jensen ME, Hirsh JA, et al. Position statement on percutaneous vertebral augmentation. J Vasc Interv Radiol. 2014;25: Savage JW, Schroeder GD, Anderson PA. Vertebroplasty and kyphoplasty for the treatment of osteoporotic vertebral compression fractures. J Am Acad Orthop Surg. 2014;22: Rousing R, Andersen MO, Jespersen SM, et al. Percutaneous vertebroplasty compared to conservative treatment in patients with painful acute or subacute osteoporotic vertebral fractures: three-months follow-up in a clinical randomized study. Spine (Phila Pa 1976). 2009;13: Papanastassiou ID, Filis A, Gerochristou MA, et al. Controversial Issues in kyphoplasty and vertebroplasty in osteoporotic vertebral fractures. Biomed Res Int Mar 4. Epub ahead of print 6. Suzuki N, Ogikubo O, Hansson T. The prognosis for pain, disability, activities of daily living and quality of life after an acute osteoporotic vertebral body fracture: its relation to fracture level, type of fracture and grade of fracture deformation. Eur Spine J. 2009;18: Buchbinder R, Osborne RH, Ebeling PR, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009;361: Kallmes DF, Comstock BA, Heagerty PJ, et al. A randomized trial of vertebroplasty for osteoporotic spinal fractures. N Engl J Med. 2009;361: Blasco J, Martinez-Ferrer A, Macho J, et al. Effect of vertebroplasty on pain relief, quality of life, and the incidence of new vertebral fractures: a 12-month randomized followup, controlled trial. J Bone Miner Res. 2012;27: Chen D, An ZQ, Song S, et al. Percutaneous vertebroplasty compared with conservative treatment in patients with chronic painful osteoporotic spinal fractures. J Clin Neurosci. 2014;21: Farrokhi MR, Alibai E, Maghami Z. Randomized controlled trial of percutaneous vertebroplasty versus optimal medical management for the relief of pain and disability in acute osteoporotic vertebral compression fractures. J Neurosurg Spine. 2011;14: Klazen CA, Lohle PN, de Vries J, et al. Vertebroplasty versus conservative treatment in acute osteoporotic vertebral compression fractures (Vertos II): an open-label randomised trial. Lancet. 2010;376(9746): Voormolen MH, Mali WP, Lohle PN, et al. Percutaneous vertebroplasty compared with optimal pain medication treatment: short-term clinical outcome of patients with subacute or chronic painful osteoporotic vertebral compression fractures. The VERTOS study. AJNR Am J Neurora- 195

6 Young-Woo Kim et al Volume 22 Number 4 December 2015 diol. 2007;28: Wardlaw D, Cummings SR, Van Meirhaeghe J, et al. Efficacy and safety of balloon kyphoplasty compared with nonsurgical care for vertebral compression fracture (FREE): a randomised controlled trial. Lancet. 2009;373(9668): 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: Dohm M, Black CM, Dacre A, et al. A randomized trial comparing balloon kyphoplasty and vertebroplasty for vertebral compression fractures due to osteoporosis. AJNR Am J Neuroradiol. 2014;35: Martin DJ, Rad AE, Kallmes DF. Prevalence of extravertebral cement leakage after vertebroplasty: Procedural documentation versus CT detection. Acta Radiol. 2012; 53: Verlaan JJ, Dhert WJ, Verbout AJ, et al. Balloon vertebroplasty in combination with pedicle screw instrumentation: A novel technique to treat thoracic and lumbar burst fractures. Spine (Phila Pa 1976). 2005;30:E Patel AA, Vaccaro AR, Martyak GG, et al. Neurologic deficit following percutaneous vertebral stabilization. Spine (Phila Pa 1976). 2007; 32: Wang LJ, Yang HL, Shi YX, et al. Pulmonary cement embolism associated with percutaneous vertebroplasty or kyphoplasty: A systematic review. Orthop Surg. 2012;4: Anderson PA, Froyshteter AB, Tontz WL Jr. Meta-analysis of vertebral augmentation compared with conservative treatment for osteoporotic spinal fractures. J Bone Miner Res. 2013;28: Zhang Z, Fan J, Ding Q, et al. Risk factors for new osteoporotic vertebral compression fractures after vertebroplasty: A systematic review and meta-analysis. J Spinal Disord Tech. 2013;26:E Bono CM, Heggeness M, Mick C, et al. North American Spine Society: Newly released vertebroplasty randomized controlled trials: a tale of two trials. Spine J. 2010;10: 골다공증성척추골절에대한경피적척추보강술 김영우 하종문 정구현 한림대학교의과대학동탄성심병원정형외과학교실 연구계획 : 문헌고찰목적 : 골다공증성척추골절의치료법인경피적척추보강술에대한최신정보를제시하고자한다. 선행문헌의요약 : 척추성형술과풍선성형술은골다공증성척추골절의치료를위해오랫동안사용되어왔다. 최근의메타분석은증상이있는골다공증성척추골절의치료방법으로골시멘트를이용한척추보강술이우수하다는강력한증거를제시한다. 대상및방법 : 관련된문헌의고찰결과 : 메타분석을통하여비수술적치료보다골시멘트를이용한척추보강술이더많은통증감소와, 기능회복과, 삶의질향상에기여한다는것을알수있다. 결론 : 골다공증성척추골절에대한경피적척추보강술은환자의입원기간을줄이고, 골절과관련된합병증을감소시키며, 기능적으로독립적인상태로빨리돌아갈수있게해준다. 색인단어 : 골다공증성척추골절, 수술적치료, 경피적척추보강술 약칭제목 : 경피적척추보강술 196

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