대한척추외과학회지제 15 권제 3 호 Journal of Korean Spine Surg. Vol. 15, No. 3, pp 157~164, 2008 국소조각골을이용한후방추체간유합술에서탈무기질화골기질의이식골강화제로서의효과 최대정 안동기 이동송 박훈석 전영원 양승진 류창욱 서울성심병원정형외과 The Effect of Demineralized Bone Matrix as a Graft Enhancer in Posterior Lumbar Interbody Fusion Using Cage and Local Bone Chips Abstract Dae Jung Choi, M.D., Dong Ki Ahn, M.D., Song Lee, M.D., Hoon Seok Park, M.D., Young Won Jeon, M.D., Seung Jin Yang, M.D., Chang Wook Ryu, M.D. Department of Orthopedic Surgery, Seoul Sacred Heart General Hospital, Seoul, Korea Study design: A randomized, controlled study Objectives: We wanted to investigate whether osteogenesis can be enhanced when a small amount of demineralized bone matrix (1 cc/segment) is mixed with local bone chips. Summary of the Literature Review: Demineralized bone matrix (DBM) has been used for spinal arthrodesis. However, there are only a few reports about its use as a composite graft with local bone chips for posterior lumbar interbody fusion Materials and Methods: Degenerative spine patients, who would normally be treated by decompression and posterior lumbar interbody fusion with using a pedicle screw system and one cage, were randomly, prospectively selected for whether they would be treated with using local bone chips mixed with 1cc of DBM (Group I: 15 patients and 19 segments) or local bone chips (Group II: 12 patients and 13 segments) for graft material. The sampling bias was investigated for gender, age, endocrine diseases, previous operation, habits (alcohol drinking, smoking), steroid medication, bone mineral density and the amount of local bone. The amount of bone formation was measured at 6 months after operation. On the sagittal and coronal reconstruction CT images, the bone formation outside of the cage was measured, and this was interpreted in a blinded fashion by 2 independent doctors who did not take part in the operations. Results: There was no sampling bias between the 2 groups except for age (Group I= 65.3±7.1, Group II=58.9±6.0, p=0.010). The ratio of local bone chips and DBM was 5.98:1 in Group I. There was moderate concurrence between the 2 interpreters (kappa coefficiency=0.494, p<0.001 for the sagittal plain images and kappa co-efficiency=0.467, p<0.001 for the coronal plain images) and Group I showed significantly more bone formation (p=0.003). Conclusion: DBM that is mixed with local bone chips, even with small amount, enhanced bone formation in the posterior lumbar interbody fusion. This is regarded to act as a graft enhancer to increase the fusion rate, even when using local bone chips for graft material, for the cases that show unfavorable conditions for fusion or for the cases that are prone to loosening of hardware. Address reprint requests to Dong Ki Ahn, M.D. Department of Orthopedic Surgery, Seoul Sacred Heart General Hospital 40-12 Chungryangri-dong, Dongdaemoon-gu, Seoul Tel: 82-2-966-1616, Fax: 82-2-968-2394, E-mail: adkajs@hanmail.net - 157 -
대한척추외과학회지 Vol. 15, No. 3, 2008 Key Words: Posterior lumbar interbody fusion, Demineralized bone matrix, Local bone chips, Graft enhancer 서 론 여러가지척추질환의치료방법으로척추유합술이사용되어왔으며전체골이식술의 50% 이상이이를위해사용되고있다 1,2). 유합성공률은기기고정술이발달하면서점차증가하였으나골이식술의표준적인방법인자가장골이식술로인한공여부의합병증은환자의만족도증진에제한이되었다. 이를극복하기위해동종골을사용하는방법, 국소조각골을사용하는방법, 골대체물질을사용하는방법, 추체간에골이식을시행하는방법, 그리고척추경나사못과케이지를이용하여고정의견고성을높이는방법등이단독또는조합으로시도되었다. 동종골의이식방법중신선동결골이나동결건조골에비해골유도성을강화시킨탈무기질화골기질의이식술은기기고정술을이용한후외측고정술에서는자가장골의보충물로서는효과가인정되었으나국소조각골이나골전도성을보유한여타인공물질과의복합사용은자가장골을사용한결과에미치지못하였다 3,4,5,6,7). 그러나국소조각골과탈무기질화골기질의복합이식을척추경나사못과케이지를이용한후방추체간유합술에사용하였을경우견고한고정을얻을수있어서이러한형태의이식골이구조적인지지가약한것을보상할수있으며골이식부의환경이골형성에보다유리하고국소농도를유지할수있어후외측고정술보다우수한결과를얻을수있을것으로예상되었다. 그러나이러한술식에대한연구는유용성을판단하는데있어서문헌을참고하기가어려웠다. 이에본저자들은감압술과정에서얻어지는국소조각골과일분절당 1 cc 의탈무기질화골기질을혼합사용하여국소조각골을단독으로사용한경우와조기골형성의정도를비교하여탈무기질화골기질이소량에서골형성강화제로작용하는가를연구하고자하였다. 였다. 50 세미만과 80 세이상, 3 분절이상, 동일분절의 3 회이상의수술, 그리고감염이합병된경우는대상에서제외하였다. 이식골의종류는무작위로선정하였으며모든수술은동일인에의해시행되었다. 총 39 명의환자들중에서 22 명 26 분절은국소조각골과각분절당 1 cc 의탈무기질화골기질을혼합하여이식하였으며 17 명 20 분절은국소조각골만을이식하였다. 이중술후 6 개월 ±2 주에전산화단층촬영을완료한 27 명 32 분절중국소조각골과탈무기질화골기질을복합이식한 15 명 19 분절을 I 군, 국소조각골만을사용한 12 명 13 분절을 II 군으로하였다. 2. 수술방법 일반적후방중앙접근법으로하여해당분절의감압을일측또는양측으로시행하고감압이일측만필요한경우는반대측의추궁판과하관절돌기까지를제거하여국소골로사용하였다. 추간판의제거는일측을통해서만시행하였으며삽입된척추경나사못과강봉을이용하여추체간격을신연시키고 I 군에서는감압도중얻 연구대상및방법 1. 연구대상 2006 년 3 월부터 2006 년 6 월까지퇴행성척추질환, 추간판질환그리고협부결손형척추전방전위증으로감압술과분절유합술이필요했던환자들을대상으로하 Fig. 1. PLIF with pedicle screws and one cage augmented with local bone chips. - 158 -
탈무기질화골기질의이식골강화효과 최대정외 어진국소골을 1~2 mm 의조각골로만들어한분절당 1 cc 의분말상태의탈무기질화골기질 (AlloMatrix ) 을혼합하여준비된이식골을적절한크기의 1 개의케이지에충전하고나머지는섬유윤창을통해반대측에이식한후편측에만케이지를삽입하였다. II 군에서는국소조각골만을전술한방법으로이식하고척추경나사못과강봉을사용하여적절한압박을가하여고정한후창상을봉합하였다 (Fig. 1). 사용된조각골의양은 20 cc 주사기에조각골을담아최대압박을가하였을때의용적을기준으로측정하였다 (Fig. 2). 3. 분석방법 전향적방법으로분석하였으며두군의성별, 연령, 음 Fig. 2. Measurement of local bone amount and 1 cc of DBM. 주, 흡연여부, 당뇨병, 그외의내분비질환, 동일분절의재수술여부, 골밀도그리고각분절당사용된국소조각골의양을조사하였다. 음주는주 2 회이상의음주를수술전 1 년이상유지한경우로하였고, 당뇨병은수술전검사당시공복혈당이 200 mg/dl 이상이거나당뇨병의병력이있는경우로하였으며, 골밀도는척추의경우퇴행성변화에의한부분골경화로계측치가실제골밀도보다높게측정되는경향이있어 DEXA(Dual-energy x-ray absorptiometry, Osteoprima ) 을사용하여고관절전자간부계측치로하였다. 술후 6 개월 ±2 주에 1 mm 두께의전산화단층촬영의시상및관상면재건영상을이용하여골형성의정도를파악하였다. 최종추시는 I 군에서는 75%, II 군에서는 71% 였다. 두군의통계적비교에있어서는각분절을한예로계산하였다. 방사선판독은전산화단층촬영재건영상상중앙시상면과추체의전방 1/3 지점의관상면각각에서케이지밖의골형성정도를판독하고본교실에서설정한기준을적용하였다 (Fig. 3). Grade I 은골이식부위에골형성이없거나미약한경우, Grade II 는골이식부위에 50% 미만의골형성이있는경우, Grade III 는골이식부위에 50% 이상의골형성은있으나연속성이불완전한경우, Grade IV 는골이식부위에미만성의연속적골형성이있고상하추체종판의연결이완전한경우로정의하였고, 각각의 Grade 에따라 1, 2, 3, 4 점을부과하였다. 본수술과관련이없는 2 명의정형외과의사가맹검으로판독하여두면의점수를합산한치를다시 2 명의판독자가합산하여계산된최종수치를비교하였다. 통계방법은두군간의표집오차는 T-test 와 Fisher s exact test, 판독자간의일치도는 Kappa test, 그리고두군 Fig. 3. Bone formation grading system which is measured at out of cage, mid-sagittal and anterior one third coronal plane CT reconstruction view. (A) Grade I: no or little bone formation at graft site. (B) Grade II: bone formation less than 50% at graft site. (C) Grade III: bone formation more than 50% at graft site. (D) Grade IV: full bone formation at graft site and continuing to adjacent end plates. - 159 -
대한척추외과학회지 Vol. 15, No. 3, 2008 Table 1. Sampling bias Characteristics Group I Group II p-value Age (years) 65.32±7.06 58.92±5.98 *0.010* Sex 5:14 4:9 0.545 Alcohol 3 4 0.364 Smoking 3 3 0.470 Previou op. 2 0 0.195 DM 5 4 0.545 Endocrine disorder 0 1 0.406 BMD -2.24±0.80-1.84±0.80 0.178 Amount of local bone -5.98±0.51-6.39±0.58 0.054 *p-value <0.050 Diabetes mellitus Bone mineral density Table 2. Bone formation score Interpretation I Interpretation II Total Average Coronal Sagittal Coronal Sagittal score score (p=0.003) Group I 10.37 2 2 2 2 08 3 3 3 2 11 3 1 2 2 08 2 2 3 3 10 3 2 3 2 10 3 3 2 2 10 3 3 3 3 13 1 1 1 1 04 3 3 1 1 08 2 3 3 3 11 2 3 3 3 11 3 1 3 3 10 2 3 3 3 11 Group II 1 1 1 1 04 6.92 2 2 1 1 06 1 1 1 1 04 1 1 1 1 04 2 1 1 1 05 3 3 3 2 11 1 2 1 1 05 1 1 1 1 04 2 2 2 2 08 3 2 3 3 11 2 1 3 2 08 2 2 2 2 08-160 -
탈무기질화골기질의이식골강화효과 최대정외 간의차이는 Mann-Whitney test 를적용하였으며 SPSS 11.5 package 를사용하였다 결 과 두군간의표집오차는표 1 과같았다. I 군에서연령이유의하게고령이었으며국소골의사용량이 I 군 5.98 cc, II 군 6.39 cc 로그차이가유의수준에근접하였고그외의비교에서는유의한차이가없었다 (Table 1). I 군에서국소조각골과탈무기질화골기질의혼합비는평균 5.98:1 이었다. 두판독자의판독은시상면상의판독 (kappa=0.494, p<0.001) 과관상면상의판독 (kappa= 0.467, p<0.001) 모두에서중등도의일치를보였다. 두판독자각각의시상면과관상면점수를합산한수치를다시총합산하여두군사이의차이를비교한결과 I 군 10.37±2.14, II 군 6.92±2.96 으로 I 군에서보다우수한골형성을보였다 (p=0.003, Table 2). 고 찰 척추유합술에있어서자가장골의이식은오랫동안표준적인방법으로사용되어왔으며유합률을증가시키는데필수적인역할을하였다 2). 척추고정기기의발달은골유합조건이불리한고령환자에게서도높은유합률을보장하게되어퇴행성요추질환에서후외측유합술은 90% 8,9,10), 후방추체간유합술은 100% 에근접하며과거에기기고정술을시행하지않을때에비해월등히증가하였다 11,12). 그러나자가장골의채취에따른합병증이골소실, 골절, 신경손상, 감염, 수술시간및출혈의증가, 만성적동통등으로다양하게보고되고있으며특히만성적동통은 30% 에달해환자의주관적만족도가감소하는원인이되고있다 13,14,15). 가장이상적인이식골로는골세포로분화해가는다양한단계의골모세포와골아세포가포함되어있어야하며, 여러형태의원시세포를골형성에관계된세포로발전시키는신호를낼수있는물질이포함, 즉골유도성이있어야하고혈관형성과골형성에필요한비계를제공하는골전도성이있어야하고이식되는수혜부의필요에따라구조적지지를제공할수있어야한다 16). 이러한조건을모두갖추고있는이식골은자가장골이유일하다고할수있으나최근에는골공여부의합병증을피하고부족한자가골을보충하기위해여러대체이식물이시도되었다. 신선동결동종골이식은최근에국내의골은행이활성화됨에따라비교적가격이저렴하고접근이용의하나골전도성만있을뿐골유도성이결여되어척추유합술에있어서의단독사용이그다지성공적이지못했으며여러 가지감염의위험을모두배제할수없다는문제점이있다. Urist 17) 가 1965 년에탈무기질화한피질골을피하와근육하에이식하여이소골형성을보고함으로서그안에주변의줄기세포를골형성에관계된세포로발전시킬수있는골유도성물질, 즉골형성단백이있다는것을증명하였다. 그후여러연구에의해이외에도 insuline like growth factor, platelet derived growth factor, fibroblast growth factor, 그리고 transforming growth factor 등이이에관계된것으로보고되었다 3,18,19,20,21,22,23). 피질골을탈무기질화하면 93% 의교원섬유와 2% 의잔여무기질, 그리고이러한골유도성물질이 5% 포함되어있는데, 피질골에묻혀있던이러한물질이탈무기질화에의해노출되어골유도를일으키게된다 7). 가장강력한골유도성을갖는 BMP 는 20microgram 을만드는데 10 kg 의피질골이필요하여 24) 생산가격이현실적이지못하므로유전자기술을이용하며생산하지만여전히고가로서실제사용에제한이있는실정이다. 이에비해동종골에서직접처리하여얻을수있는탈무기질화골기질은비교적현실적인가격에생산이가능하나최종사용가능단계까지의여러공정에의해골유도성물질의활동능력이심각하게영향을받을수있어상업적으로생산되어있는여러종류의상품은각기골유도능력의차이가있을수있는것으로보고되었다 25,26). 공여골을혈청학적, 현미경적으로선발시험을하고의학적, 사회적과거력상결격이있는가를조사하고알콜과항생제을사용하여세척하는것까지는모든제품이동일하나담체 (carrier) 로사용하는물체와혼합비, 최종무균적처리방법, 그리고최종보관상태등은각회사가고유한방법을쓰고있다. 본연구에사용된 AlloMatrix 는담체로 calcium sulfate hemihydrate 를사용하고탈무기질화골기질 86% 에 14% 의담체을혼합하고있다. 최종무균처리방법으로는 electron beam 을채택하고동결건조상태로상온보관하도록되어있다. 척추유합술에있어서탈무기질화골기질의사용은자가장골과혼합하여사용하였을경우골보충제또는골형성강화제로는역할이인정되나단독으로사용하거나골전도성을갖는인공물질과혼합사용하였을경우는골유합이성공적이지못한것으로보고되어여전히자가장골의채취를완전히배재할수없는것으로생각되었다. Sassard 등 27) 은후외측유합술에있어서국소골과탈무기질화골기질을 1:3 으로혼합사용하였을경우자가장골을사용한경우와유사한유합율은얻을수있다고하였으나많은양을사용해야함으로서지나친비용의증가를피할수없다. 본저자들은감압술이필요한퇴행성척추질환에있어서수술도중얻어지는 - 161 -
대한척추외과학회지 Vol. 15, No. 3, 2008 국소골을소량의탈무기질화골기질과혼합하여후방추체간유합술을시행함으로서자가장골의채취를배재하고비용부담이저렴하면서골유합을증가시킬수있는방법이유용한가를증명하고자하였다. 척추경나사못과국소조각골을사용한후방추체간유합술은신등 28,29) 에의하면 47.6%, 안등 30) 에의하면 75% 의성공률을보였으나삼피질자가장골을사용한경우에는미치지못하였고붕괴유합을보인경우가많았다. 그러나케이지를병용함으로서유합률을 100% 까지높일수있다고보고되었으며 11,22), Harris 등 31) 은단일케이지만을사용하여도생역학적으로근소한차이가있으나유합률과임상결과에는차이가없다고하였다. 본저자들의경험으로는골다공증이있는고령환자나추체종판의골경화상을보이는환자에게서편측케이지만을사용하였을경우, 유합전에내고정물의해리가발생하거나추체간의이식골이흡수되어버리는경우를빈번히경험하였다. 이에탈무기질화골기질을소량혼합하여골형성이조기에증가하는가를증명하면이러한경우에골유합을증가시키는데도움이될것으로생각되었다. 일반방사선소견으로는케이지에의해골영상이중복되어정확한유합의판독에어려움이있고수술후골유합에필요한충분한시간이경과한후에는탈무기질화골기질의효과를증명하는데보다다양한교란인자가발생할것으로생각되어수술후 6 개월에전산화단층촬영을이용한시상면과관상면의재구성사진을사용하여골형성의정도를계측하였다. 탈무기질화골기질이이소골을형성하는기전은일차로연골을형성하고이것이다시골로치환되어가는연골내골화에의한것인데, Wang 등 32,33,34) 의연구에의하면두개골의결손부위에서는직접막내골화를통해골아세포가생산되는것이관찰되어이식수혜부의조건에따라골형성기전이다를수있는것으로생각되었고 Kenneth 등 1) 은이러한차이의이유를해부학적부위에따라간엽줄기세포가갖고있는연골형성또는골형성에관계하는단백질에대한수용체의우세가서로다르기때문인것으로설명하였다. 횡돌기간에비해추체간은혈액순환이왕성한넓은추체종판이있으며추체의해면골에서골모세포로분화할수있는원시세포의공급이원활할것으로생각되어연골형성단계를거치지않고직접골형성이가능할것으로예상되었다. 또한이식후국소에탈무기질화골기질의농도를유지시키는것이횡돌기간에비해용이할것으로생각되었다. 본연구에서는실험군과대조군의표집오차를줄이기위해전향적연구방법을사용하였으며동일한기간내의대상에대해무작위로이식방법을선택하여한명의의사가모든수술을시행하였다. 2 개의케이지를사용 할경우, 케이지에가려져서유합상태를판단하기가어려울것으로생각되어 1 개만을사용한경우로제한하였고일측접근방법을사용하여수핵제거와추체종판의연골제거를시행하였다. 연령, 유합분절수그리고수술횟수등의교란효과를배제하기위해 50 세미만과 80 세이상, 3 분절이상의유합, 그리고해당부위에 3 회이상의수술은대상에서제외하였다. 그러나표집오차의검증에서 1 군이유의하게고령이었으며유의수준에는이르지않았으나재수술횟수, 사용된국소조각골의양에서모두 1 군의조건이골형성에불리하게표집되어본연구의제한점으로생각된다. 그러나골형성정도의분석결과 1 군에서뚜렷하게골형성이우수하게관찰되어탈무기질화골기질이골형성을증가시키는이식골강화제로서의역할이있다고판단하는데는오류가없을것으로생각된다. 조기에골형성을증가시켰다는것은척추유합술에서유합의성공여부가유합의진행과고정기구의실패사이의시간경쟁이라는것을고려할때 1) 최종적으로골유합을증가시키는데당연히유리하게작용할것으로생각된다. 본연구에서사용된국소조각골과의비율은 5.98:1 이었으나어떠한혼합비에서골형성이최대가될지는아직알수없으며이를위해서는다양한비율의복합이식에대한비교연구가필요할것으로생각된다. 결 론 후방추체간유합술에서국소조각골과혼합하여사용된탈무기질화골기질은소량에서도골형성을증가시켰으며, 이로미루어골유합에불리한조건이있거나골다공증으로고정기구의해리가예상되는환자에게서국소조각골과혼합하여사용하였을경우에추체간유합율을증가시킬수있는골형성강화제로유용할것으로생각된다. 참고문헌 01) Lee KJ, Roper JG, Wang GC: Demineralized bone matrix and spinal arthrodesis. Spine 2005; 5: 217-223. 02) Vaccaro AR, Chiba K, Heller JG, et al: Bone grafting alternatives in spinal surgery. Spine 2002; 2: 206-215. 03) Aspenberg P, Albrektsson T, Thorngren K: Local application of IGR-1 to healing bone Acta Orthop Scan 1989; 60: 607-610. 04) Cook DB, Dalton JE, Tan EH, Whitecloud TS, Rueger DC: In vivo evaluation of recombinant human osteogenic - 162 -
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대한척추외과학회지 Vol. 15, No. 3, 2008 induced osteogenesis in rat calvarial bone defects:i. Differences in the cellular response to demineralized bone matrix implanted in calvarial defects and in subcutaneous sites. Calcif Tissu Int 1999; 65: 156-165. 33) Wang J, Glimcher MJ: Charaterization of matrix induced osteogenesis in rat calvarial bone defects II Origins of bone-forming cells. Clcif Tissue Int 1999; 65: 486-493. 34) Wang J, Tang R, Gerstenfeld LC, Glimcher MJ: Characterization of demineralized bone matrix-induced osteogenesis in rat calvarial bone defects. Gene and protein expression. Calcif Tissue Int 2000; 67: 314-320. 국문초록 연구계획 : 후방요추체간유합술에서국소조각골에혼합된탈무기질화골기질의효과에대한전향적비교연구. 연구목적 : 탈무기질화골기질은척추유합술에널리쓰이고있으나국소골과의복합이식으로후방요추체간유합술식에사용된보고는매우드물어유용성을판단하기가어려웠다. 이에본저자들은소량의탈무기질화골기질을 (1 분절당 1 cc) 국소골과혼합이식하였을때골형성을증가시키는가를조사하고자하였다. 대상및방법 : 퇴행성척추질환으로후방감압술과후방요추체간유합술로치료를계획한환자들중감압도중얻어진국소조각골과각분절당 1 cc의탈무기질화골기질을혼합하여복합이식한 I군 (15명 19분절 ) 과국소조각골만을이식한 II군 (12명 13분절 ) 을전향적, 무작위로선택하였다. 모든예에서척추경나사못고정술과일측성단일케이지삽입술을시행하였다. 두군간에표집오차를검증하고 ( 성별, 나이, 내분비질환, 이전수술여부, 음주, 흡연습관, 부신피질홀몬제복용, 골밀도, 사용된국소골의양 ), 술후6개월에전산화단층촬영의시상면과관상면재건영상상, 케이지가삽입되지않은부위의골형성의정도를수술과무관한 2명의의사가맹검으로판독하여합산한결과를비교하였다. 결과 : 양군간에유의한연령차이가있었으나 (I군 =65.3±7.1, 2군 =58.9±6.0, p=0.010) 그밖의표집오차는없었다. I 군에서국소조각골과탈무기질화골기질의혼합비는 5.98:1이었다. 두판독자는중등도의일치를보였으며 ( 시상면 ; kappa co-efficiency=0.494, p<0.001, 관상면 ; kappa co-efficiency=0.467, p<0.001), I군에서보다우수한골형성이관찰되었다 (p=0.003). 결론 : 후방요추체간유합술에서국소조각골과혼합하여사용된탈무기질화골기질은소량에서도골형성을증가시켰으며, 이로미루어골유합에불리한조건이있거나골다공증으로고정기구의해리가예상되는환자에게서국소조각골과혼합하여사용하였을경우에추체간유합률을증가시킬수있는골형성강화제로유용할것으로생각된다. 색인단어 : 후방요추체간유합술, 탈무기질화골기질, 국소조각골, 이식골강화제 통신저자 : 안동기서울특별시동대문구청량리동 40-12 서울성심병원정형외과 Tel: 82-2-966-1616 Fax: 82-2-968-2394 E-mail: adkajs@hanmail.net - 164 -