207 pissn : 1226-2102, eissn : 2005-8918 Original Article J Korean Orthop Assoc 2016; 51: 207-213 http://dx.doi.org/10.4055/jkoa.2016.51.3.207 www.jkoa.org 후측방유합술시탈무기질화골기질을적용한경우의유효성과안정성 안재성 이호진 박유진재진 노창균 이기영 충남대학교의과대학정형외과학교실 Efficiency and Safety of Demineralized Bone Matrix for Posterolateral Fusion Jae-Sung Ahn, M.D., Ho-Jin Lee, M.D., Eugene Park, M.D., Chang-Kyun Noh, M.D., and Ki Young Lee, M.D. Department of Orthopaedic Surgery, Chungnam National University School of Medicine, Daejeon, Korea Purpose: The purpose of this study is to analyze the effects of demineralized bone matrix on posterolateral lumbar fusion. Materials and Methods: From 2009 to 2012, 30 patients who had undergone posterolateral fusions using demineralized bone matrix (group I) and 30 who had received autogenous posterior iliac bone grafts (group II) were investigated. Bone union was determined by evaluating serial simple lumbar radiographs taken during the 24 months after surgery. Bone status was classified according to Lenke s scale and the bone fusion was finally determined by flexion/extension lateral radiographs. We also examined halo signs around the pedicular screws evident on the radiographs, scored back pain using a visual analogue scale (VAS), and Oswestry disability index (ODI) score 2 years after surgery to evaluate clinical status of patients. Results: In group I, 19 patients showed union and 11 patients did not; the values for group II were 22 and 8. These proportions did not differ significantly (p=0.57). Time to union was somewhat shorter in group II (25.3±7.9 weeks), but did not differ significantly from that of group I (p=0.097). No statistical significance in the periscrew Halo count, VAS for back pain, and ODI score was observed between the two groups. Conclusion: The union rate after using demineralized bone matrix for lumbar posterolateral fusion is similar to that attained when autogenous bone grafts are employed, and lacks the morbidity associated with such grafts. Thus, demineralized bone matrix is an effective bone graft substitute when posterolateral fusion surgery of the lumbar spine is required. Key words: lumbar vertebrae, posterior vertebral fusion, demineralized bone matrix, fusion rate 서론 척추유합술시에사용하는자가골은골형성, 골유도및골전도의성질을모두지닌가장이상적인재료로서골유합률이높고저렴하여흔히사용되어왔다. 1-3) 하지만골편채취량의제한, 수 Received November 7, 2015 Revised December 20, 2015 Accepted January 26, 2016 Correspondence to: Ho-Jin Lee, M.D. Department of Orthopaedic Surgery, Chungnam National University School of Medicine, 266 Munhwa-ro, Jung-gu, Daejeon 35015, Korea TEL: +82-42-280-7353 FAX: +82-42-252-7098 E-mail: leeleo98@gmail.com 술시간의지연및공여부위의통증, 출혈, 창상부위의감염, 신경손상과이식골의붕괴및흡수등의합병증이발생할수있다. 4-7) 이에동종골, 골이식대체재등이골유합술에사용되기도한다. 특히골이식대체재는자가골이식이제한적이거나여러차례의재수술로인하여다분절의유합이필요할경우에유용하다. 골이식대체재로는골유도의성질이강한탈무기질화골기질 (demineralized bone matrix), 비콜라겐성및콜라겐성단백, 혈소판으로부터추출한자가성장인자농축성분등이있고골전도의역할을하는인산칼슘 (calcium phosphate, hydroxyapatite), 황산칼 The Journal of the Korean Orthopaedic Association Volume 51 Number 3 2016 Copyright 2016 by The Korean Orthopaedic Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
208 Jae-Sung Ahn, et al. 슘 (calcium sulfate) 등의세라믹제재들이있다. 8-12) 탈무기질화골기질은동종골의면역성을제거한형태로, 골유도성이없으나탈회과정을거친후골재생의촉진효과를지니게된다. 12) 이에는골형성단백질 (bone morphogenetic protein, BMP) 등의골성장인자가함유되어있어미분화간엽세포 (mesenchymal stem cell) 를증식시키고세포들이조골세포 (osteoblast) 로분화하도록자극한다. 13) 이는자가골이식과비교하여도골유도및골전도의능력이유사한것으로보고하고있다. 14-16) 또한탈무기질화골기질은최근동종골이식재와함께사용시골증량제 (bone extender) 의역할뿐아니라골형성증량제 (enhancer) 로작용하여척추수술시이용되는골이식대체물로많이사용되고있다. 17,18) 하지만그효과에대해서는연구자에따라유합률에다양한결과를보고하고있으며, 탈무기질화골기질의종류에따라그효능이다양하게보고되고있다. 11,19-24) 이에본연구는요추후회방유합술이필요하였던환자를대상으로동종골이포함된탈무기질화골기질을사용한군 (I) 과후방장골의자가골을사용한군 (II) 을비교하여분석하였다. 대상및방법 1. 연구대상 2009년부터 2012년까지충남대학교병원에서척추전방혹은후방전위증, 척추관협착증등의요추부퇴행성질환으로 3개분절이하로후측방유합술을받고추적관찰이완료된환자를대상으로하였다. 만 20세이상 75세미만의남녀에서 60예의환자를연구대상으로선정하였고, 골절, 급성감염의기왕력, 출혈성질환, 악성종양자및악성종양병력이있던경우, 그리고책임연구자의판단으로본임상시험수행이곤란하다고여겨지는대상자는본연구대상에서제외하였다. 유합술시상품화된동종골첨가탈무기질화골기질인 Allomix (CGBIO, Seongnam, Korea) 를적용한군 (I) 과환자의후방장골에서자가골편을채취하여이식한군 (II) 으로나누어비교분석하였다. 본연구는충남대학교병원임상시험심사위원회 (institutional review board, IRB) 의승인을받아진행되었다 (IRB No. 2015-06-046). 2. 수술방법수술은한명의척추외과전문의가시행하였다. 연구대상으로포함된전환자에서복와위를통한후방도달법으로정중선을절개하여이환부위를노출시킨후후방감압술을시행하였고척추경나사못과강봉 (Stryker XIA, Kalamazoo, MI, USA) 을이용하여내고정하였다. 해당분절의감압술은양측으로시행하고전추궁판, 전하관절돌기와상관절돌기의일부까지제거하였으며채취된국소골은두군모두에서이식재와혼합하여사용하였다. I 군에서는탈무기질화골기질을유합분절당 2.5 ml를취하여국소골과혼합하여이식하였고 II군에서는자가골편을분절당 2.5 ml로제한하여후방장골에서채취한후국소골과혼합하여후측방유합술을시행하였다. 채취된자가골및국소골의양은채취후 1-2 mm 조각골로만들어 10 ml 주사기에담아최대압박을가하였을때의용적을기준으로각각측정하였다. 3. 술후관리후측방유합술을시행후 8주간흉요천추보조기를착용하도록하였다. 보행은수술후 3일째부터보행기를이용하여시도하였다. 4. 연구방법후향적연구로서대상환자의병록기록과검사소견을토대로임상평가를하였으며방사선적소견은수술전, 후, 3, 5, 8개월, 1년, 2년째에단순방사선사진촬영을시행하여본수술과관련이없는 1명의척추외과전문의 (X) 와 1명의영상의학과전문의 (Y) 에의해평가를시행하였고각각 2회에걸쳐측정하였다. 관찰자들에게는환자에대한사전정보를전혀제공하지않았고, 계측시기에따른기억효과를배제하기위해 2차계측은 1차계측후최소 2주이상의간격을두었다. 골유합이완성되는기간은방사선사진에서유합골의변화가더이상일어나지않는최종시점으로결정하였으며, 골유합은전후방방사선사진에서 Lenke s scale 25) 에따라 type A, B, C, D로분류한후 (Table 1), A와 B등급중굴곡-신연측면방사선사진상 3 mm 이하의전위를보이고 5도미만의각형성을보이는경우로정의하였으며 (Fig. 1), 나머지는모두불유합으로정의하였다. 또한수술후 2년째척추경나사못주위방사선투과대 (Periscrew Halo sign) 의여부를조사하였으며단 Table 1. Lenke s Scale* Evaluation Type Description Union A Definitely solid with bilateral stout fusion masses present B Probably solid with unilateral stout fusion mass & contralateral thin fusion mass Nonunion C Probably not solid with thin unilateral fusion mass & probable pseudoarthrosis on the contralateral side D Definitely not solid with thin fusion masses bilaterally with obvious pseudoarthrosis or bone graft dissolution bilaterally *Data from the article of Lenke et al. (J Bone Joint Surg Am. 1992;74:1056-67). 25)
209 Efficiency and Safety of Demineralized Bone Matrix for Posterolateral Fusion A B C D Figure 1. A 71-year-old female with degenerative lumbar disease underwent surgery with posterior decompression and posterolateral fusion using autogenous posterior iliac bone graft mixed with local bone. (A) Initial anteroposterior and lateral radiographs show degenerative lumbar disease with L4 5 anterolisthesis. (B) Postoperative anteroposterior and lateral radiographs show that the posterior laminectomy and posterolateral fusions were done on the level of L3 4 5 S1. (C) At 30 weeks after the operation, anteroposterior and lateral radiographs show that the fusion mass was formed bilaterally, which was defined as Lenke s scale A. (D) There was no significant translation and angulation on the flexion-extension lateral radiographs at 30 weeks after surgery. 결 과 순 방사선 사진 촬영에서 척추경 나사못 주위 방사선 투과대를 관찰하여 1 mm 이상의 방사선적 투과대가 확인될 때 의미가 있 는 것으로 판단하였다. Table 2는 선정된 60명에 대하여 나이, 성별, 흡연여부, 수술을 시 환자의 술 후 임상증상에 대한 평가는 수술 후 2년째의 요통의 행한 분절 수, 그리고 분절 부위에 대하여 양 군을 비교하여 보여 정도와 Oswestry disability index (ODI)를 이용하여 평가하였으며 준다. 이 항목들에 따른 두 군 간의 통계적 차이는 없었으며 특히 요통의 정도는 시각통증등급(visual analogue scale, VAS)을 이용하 제5요추-1천추 분절의 포함 여부에 있어서도 통계적 차이는 없 여 측정하였다. 통계적 분석은 SPSS ver. 12.0 (SPSS Inc., Chicago, 었다(p=0.267). 그리고 수술 중 채취하여 이식한 국소골의 양을 분 IL, USA)을 이용하였으며, 각 군의 비교는 연속 변수의 경우에는 절당으로 환산하여 두 군 간의 차이를 비교하였으나 통계적 유의 Kologorov-Smirnov test를 통하여 정규성 검증을 한 후 정규분포 성은 없었다(p=0.11). 를 하는 경우에는 t-test를, 그렇지 않은 경우나 서열변수의 경우 Table 3은 양 군에서 Lenke s scale에 따른 분류 및 유합률의 차 에는 Mann-Whitney U-test를 실시하였다. 명목 변수에 대해서는 이를 비교하여 보여주며 수술 후 유합까지의 소요시간, 척추경 chi-square test와 Fisher s exact test를 하였다. 관찰자내 재현성 및 나사못 주위 방사선 투과대 여부, 요통의 VAS 점수 및 ODI에 대 관찰자간 신뢰성은 kappa test를 통하여 평가하였다. 하여 각 군의 차이를 보여준다. 관찰자내 판독은 X (kappa=0.526, p 0.001)와 Y (kappa=0.493, p 0.001) 모두 중등도의 일치를 보
210 Jae-Sung Ahn, et al. Table 2. Demographic Data Characteristic Group I* Group II p-value Age (yr) 59.8±10.3 58.6±7.8 0.67 Sex 0.60 Male 11 (36.7) 14 (46.7) Female 19 (63.3) 16 (53.3) Smoker 9 (30.0) 6 (20.0) 0.55 No. of segment 0.873 1 level 14 (46.7) 13 (43.3) 2 level 6 (20.0) 7 (23.3) 3 level 10 (33.3) 10 (33.3) Operation level L1 2 2 0 L2 3 8 12 L3 4 13 16 L4 5 26 17 L5 S1 7 12 Operation level group 0.267 <L5 23 (76.7) 18 (60.0) L5 7 (23.3) 12 (40.0) Local bone graft harvesting per segment (ml) 19.1±3.0 17.8±3.3 0.11 Values are presented as mean±standard deviation, number (%), or number only. *Undergone posterolateral fusions using demineralized bone matrix (n=30). Received autogenous posterior iliac bone grafts (n=30). 였으며, 두관찰자간판독 (kappa=0.412, p<0.001) 또한중등도의 일치를보였고유합률에있어서, 두군에서통계적으로유의한차이는보이지않았다 (p=0.57). 유합까지의소요시간에있어서, II 군에서평균 25.3±7.9주로상대적으로작았으나두군간의통계적차이는없었다 (p=0.097). 수술후 24 개월에평가한척추경나사못주위방사선투과대여부, 요통의 VAS 점수 (p=0.39) 와 ODI (p=0.22) 에있어서도각각양군간의통계적인유의성은없었다. II군에서골채취후발생한공여부합병증은 1건 (3.3%) 의천부수술부위감염이었으며정맥항생제투여로해결되었다. 고찰 척추유합술을시행하는경우고정술후안정성을획득하기위하여골이식술이필수적이며골형성 (osteogenesis), 골유도 (osteoconduction), 그리고골전도 (osteoinduction) 를모두가진자가골이식이가장이상적으로알려져골이식의재료로표준화되어왔다. 1-3) 하지만골채취로인한공여부골절, 통증, 혈종형성, 신경손상, 감염및채취골량의제한등의문제점이있다. 4-7) 이에대한대안으로골이식대체재를이용한유합술을시행할수있으며 Table 3. Results Factor Group I* Group II p-value Lenke s scale A 11 (36.7) 14 (46.7) B 10 (33.3) 9 (30.0) C 9 (30.0) 7 (23.3) D 0 (0) 0 (0) Fusion 0.57 Success 19 (63.3) 22 (73.3) Fail 11 (36.7) 8 (26.7) Mean union time (wk) 27.7±7.2 25.3±7.9 0.097 Periscrew Halo sign 6 (20.0) 5 (16.7) 1.0 Back pain (VAS) 2.4±1.6 2.0±1.2 0.39 ODI 11.3±2.8 10.7±2.2 0.22 Donor-site complication 0 (0) 1 (3.3) Values are presented as number (%) or mean±standard deviation. *Undergone posterolateral fusions using demineralized bone matrix (n=30). Received autogenous posterior iliac bone grafts (n=30). VAS, visual analog scale; ODI, Oswestry disability index. 탈무기질골기질은다양한대체재중하나이다. 이것은골형성을유도하는 BMP 등의골성장인자가함유되어있어미분화간엽세포를증식시키고주위세포들이조골세포로분화되도록자극하기때문에동종골이식제와함께골이식대체물로최근많이사용되고있다. 12,14,26,27) Martin 등 19) 은탈무기질화골기질은유합술에사용시골촉진재 (enhancer) 로써역할을할수있다고보고하였으나 Helm 등 20) 은탈무기질화골기질의사용시오히려골의유합을저해하는결과를보였다고보고하였다. 또한다기관이참여한경추유합술에대한연구에서는탈무기질화골기질을동종골과함께사용한경우에서이식골의불유합률과붕괴가더높았다고보고한바있다. 11) Sassard 등 21) 은후외측유합술에있어서국소골과탈무기질화골기질을 1:3으로혼합사용하였을경우자가장골을사용한경우와유사한유합률을얻을수있다고보고한바있다. 이러한탈무기질화골기질에대한다양하고혼란스러운보고들은그것이상품화되어나오기까지거치게되는여러공정이정해져있지않고, 각회사에따라달라비롯되는것으로생각된다. 실제로탈무기질화골기질이최종상품화까지의여러단계에의해골유도성물질의능력이심각하게영향을받을수있어시중에존재하는각상품들은그골유도능력에서차이가있을수있는것으로보고되었다. 28,29) 공여골을혈정학적, 현미경적으로선발시험을하고의학적, 사회적과거력상결격이있는가를조사하며알코올과항생제를사용하여세척하는것까지는모든제품이동일하나담체 (carrier) 로사용하는물체와그혼합비, 최종무균적처리방법, 그리고최종보관상태등은각회사가고유한방
211 Efficiency and Safety of Demineralized Bone Matrix for Posterolateral Fusion 법을쓰고있다. 27) 본연구에사용된 Allomix 는담체로서탈무기질화골기질자체를사용하여 100% 탈무기질화골기질이며최종무균처리방법으로감마선을이용한방사선멸균을채택하고동결건조상태로상온보관하도록되어있다. 본연구에서는 60예의퇴행성요추질환이있는환자를대상으로후측방유합술시에이식제로서, I군에서는 Allomix 를분절당 2.5 ml로제한하고후방감압술시얻어진국소골과혼합하여사용하고 II군은후방자가장골이식을역시분절당 2.5 ml로제한하고국소골과혼합하여사용한후비교분석하였다. 본저자들은감압술중얻어지는국소골을소량의탈무기질화골기질과혼합하여후측방유합술을시행함으로써자가장골의채취를배재하고그합병증을최소화하면서골유합을증가시킬수있는가를증명하고자하였다. II군에서골채취후발생한공여부합병증은 1건으로, 천부수술부위감염이었다. 수술후의유합률, 골유합시기에서두군간의유의한차이를볼수없었으며방사선적유합정도의평가에서도통계적차이는없었다. 수술후 2년째에시행한척추경나사못주위방사선투과대소견의유무, 요통의 VAS 점수, ODI 점수에서도역시두군간의유의한차이는보이지않았다. 이에본연구에서는골전도성을지닌탈무기질화골기질은자가골이식을대체할수는없지만, 그것의한계점및제한점을극복하고유합술시유사한결과를가져올수있는훌륭한골이식확장재혹은보조재임을확인할수있었다. 본연구의제한점으로는첫째, 두군의유합률은통계적으로유의한차이를보이지않으나탈무기질화골기질을사용한군의유합률 (63.3%) 이기존의연구들 14-18) 에서발표한유합률에비하여다소낮다. 이는두군의수가상대적으로적어발생한결과로생각되며추후더많은환자군으로추가연구가필요할것으로생각된다. 둘째, 본연구에서는수술후유합여부를판단하는데있어서컴퓨터단층촬영을제외하고단순방사선촬영만을사용하여결과를분석하여그신빙성에의문을제기할수있을것으로생각된다. 이에저자들은굴곡-신연측면방사선사진을추가로분석하였고관찰자내재현성및관찰자간신뢰성을평가하여분석하여이를보완하고자하였다. 마지막으로단일제품을사용하여연구의신뢰성을부여하였으나특정제품에국한된결과의가능성을배제할수없어추후다양한제품군간의비교연구가필요할것으로생각된다. 결론 후측방유합술시탈무기질화골기질은국소자가골이식으로인한공여부골절, 통증, 혈종형성, 신경손상, 감염등의합병증을피할수있으며유합률에있어서도좋은결과를보이는훌륭한골이식확장재혹은보조재로생각된다. CONFLICTS OF INTEREST The authors have nothing to disclose. REFERENCES 1. Cloward RB. Lesions of the intervertebral disks and their treatment by interbody fusion methods. The painful disk. Clin Orthop Relat Res. 1963;27:51-77. 2. Bono CM, Lee CK. Critical analysis of trends in fusion for degenerative disc disease over the past 20 years: influence of technique on fusion rate and clinical outcome. Spine (Phila Pa 1976). 2004;29:455-63; discussion Z5. 3. Dawson EG, Lotysch M 3rd, Urist MR. Intertransverse process lumbar arthrodesis with autogenous bone graft. Clin Orthop Relat Res. 1981;154:90-6. 4. Dick HM, Strauch RJ. Infection of massive bone allografts. Clin Orthop Relat Res. 1994;306:46-53. 5. Gupta AR, Shah NR, Patel TC, Grauer JN. Perioperative and long-term complications of iliac crest bone graft harvesting for spinal surgery: a quantitative review of the literature. Int Med J. 2001;8:163-6. 6. Wiltberger BR. Intervertebral body fusion by the use of posterior bone dowel. Clin Orthop Relat Res. 1964;35:69-79. 7. Summers BN, Eisenstein SM. Donor site pain from the ilium. A complication of lumbar spine fusion. J Bone Joint Surg Br. 1989;71:677-80. 8. Bucholz RW, Carlton A, Holmes RE. Hydroxyapatite and tricalcium phosphate bone graft substitutes. Orthop Clin North Am. 1987;18:323-34. 9. Lane JM, Bostrom MP. Bone grafting and new composite biosynthetic graft materials. Instr Course Lect. 1998;47:525-34. 10. Lee SK, Kim CH, Cheong JH, Bak KH, Kim JM, Oh SJ. Efficacy of calcium sulfate pellets as bone graft substitute in lumbar posterolateral fusion. J Korean Neurosurg Soc. 2001;30: 605-10. 11. An HS, Simpson JM, Glover JM, Stephany J. Comparison between allograft plus demineralized bone matrix versus autograft in anterior cervical fusion. A prospective multicenter study. Spine (Phila Pa 1976). 1995;20:2211-6. 12. Vaccaro AR, Stubbs HA, Block JE. Demineralized bone matrix composite grafting for posterolateral spinal fusion. Orthopedics. 2007;30:567-70.
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213 pissn : 1226-2102, eissn : 2005-8918 Original Article J Korean Orthop Assoc 2016; 51: 207-213 http://dx.doi.org/10.4055/jkoa.2016.51.3.207 www.jkoa.org 후측방유합술시탈무기질화골기질을적용한경우의유효성과안정성 안재성 이호진 박유진재진 노창균 이기영 충남대학교의과대학정형외과학교실 목적 : 요추후측방유합술시탈무기질화골기질의효과를분석하고자한다. 대상및방법 : 2009 년부터 2012 년까지탈무기질화골기질을사용한 30 예 (I 군 ) 와자가후방장골을사용한 30 예 (II 군 ) 를조사하였다. 수술후 2 년동안주기적단순방사선사진을촬영하여 Lenke s scale 에따라분류후굴곡 - 신연측면방사선사진을통해골유합여 부를확인하였다. 또한수술후 2년째척추경나사못주위방사선투과대여부를조사하였으며, 환자의임상증상평가를위해 visual analogue scale 과 Oswestry disability index (ODI) 점수를각각조사하여분석하였다. 결과 : I군중 19예는유합, 11예는불유합되었으며, II군중 22예는유합, 8예는불유합되어두군에서통계적으로유의한차이는보이지않았다 (p=0.57). 유합이일어난주수에있어서도두군간의통계적차이는없었다 (p=0.097). 수술후 2년째에평가한척추경나사못주위방사선투과대여부, 요통과 ODI 점수에있어서도각각양군간의통계적인유의성은없었다. 결론 : 요추후측방유합술시탈무기질화골기질의사용은자가골과유사한골유합률을보이며, 자가골이식에따른합병증을피할수있어효과적인골대체재로생각된다. 색인단어 : 요추, 후방척추유합술, 탈무기질화골기질, 유합률 접수일 2015 년 11 월 7 일수정일 2015 년 12 월 20 일게재확정일 2016 년 1 월 26 일책임저자이호진 35015, 대전시중구문화로 266, 충남대학교의과대학정형외과학교실 TEL 042-280-7353, FAX 042-252-7098, E-mail leeleo98@gmail.com 대한정형외과학회지 : 제 51권제 3호 2016 Copyright 2016 by The Korean Orthopaedic Association This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.