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529 pissn : 1226-2102, eissn : 2005-8918 Original Article J Korean Orthop Assoc 2017; 52: 529-536 https://doi.org/10.4055/jkoa.2017.52.6.529 www.jkoa.org 쇄골간부골절에서잠김금속판을이용한치료 : 관혈적금속판고정술과최소침습적금속판고정술의비교 방진영 박병욱 서용민 김대욱 이동현 김영복 김영창 김지완 인제대학교의과대학해운대백병원정형외과학교실 Surgical Treatment of Clavicle Midshaft Fractures Using a Locking Compression Plate: Conventional Open Reduction and Plating with Internal Fixation versus Minimal Invasive Plate Osteosynthesis Jin-Young Bang, M.D., Byung Ook Park, M.D., Yong Min Seo, M.D., Dae Wook Kim, M.D., Dong-Hyun Lee, M.D., Youngbok Kim, M.D., Young Chang Kim, M.D., Ph.D., and Ji Wan Kim, M.D., Ph.D. Department of Orthopaedic Surgery, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea Purpose: The purpose of this study was to make a comparison between minimally invasive plate osteosynthesis (MIPO) and conventional open reduction and plating (COP) to treat displaced clavicle shaft fractures. Materials and Methods: We retrospectively reviewed patients with clavicle shaft fractures, who underwent surgery by using a locking plate between May 2011 and August 2016. The inclusion criteria were: 1) displaced 20 mm, 2) acute fracture of less than 2 weeks from injury, 3) skeletally mature patients, and 4) follow-up of at least 6 months. The demographic data and clinical outcomes, including operation time, fracture union rate, union time, shortening of clavicle, shoulder functional score (University of California at Los Angeles score), and complications, were evaluated. The clavicle length ratio was measured to evaluate shortening. We compared the clinical outcomes between two groups: the COP group that included 21 patients treated with COP (group 1) and the MIPO group that included 19 patients treated with MIPO (group 2). Results: In all cases, union of fractures was successfully achieved. The mean union time was 14.9 weeks in group 1 and 14.2 weeks in group 2 (p=0.713). Both groups had good functional scores (34.0 vs. 33.7, p=0.658). Group 2 had shorter operation time and less bleeding. There were no secondary interventions or infections. The clavicle length ratio was similar between the two groups; and all patients in both groups showed no shortening (less than 3%). There were no implant failures in either group. Conclusion: The clinical and radiologic outcomes were satisfactory in both groups. We suggest that MIPO may be a safe and effective method for displaced clavicle shaft fractures. Key words: clavicle, clavicle fracture, minimally invasive plate osteosynthesis, plate, outcomes 서론 Received March 14, 2017 Revised May 12, 2017 Accepted June 7, 2017 Correspondence to: Ji Wan Kim, M.D., Ph.D. Department of Orthopaedic Surgery, Haeundae Paik Hospital, Inje University College of Medicine, 875 Haeun-daero, Haeundae-gu, Busan 48108, Korea TEL: +82-51-797-0668 FAX: +82-51-797-0669 E-mail: bakpaker@hanmail.net 쇄골간부골절은과거에는비수술적치료의대상이었으나최근에는골절의전이로인한문제점, 동반손상요인, 환자측요인을고려하여수술적치료가선호되고있다. 1-4) 이러한쇄골간부골절의수술적치료로는금속정을이용한내고정술, 유관나사못을이용한고정, 금속판을이용한내고정술등다양한수술방법이 The Journal of the Korean Orthopaedic Association Volume 52 Number 6 2017 Copyright 2017 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.

530 Jin-Young Bang, et al. 제시되었다. 5-8) 그러나금속정을사용한경우생물학적고정을얻을수있지만금속정파손, 회전불안정성및길이단축의문제가발생하는것으로알려져있다. 8) 이러한단점을극복하기위하여관혈적정복및금속판고정술이많이시행되고있고우수한결과를보이고있다. 9,10) 관혈적고정및금속판고정술의단점으로는내고정시광범위한골막박리로인하여심부감염, 불유합및향후금속판제거술시재골절의문제가발생할수있다. 11-13) 이러한합병증을줄이기위해최근생물학적고정술의중요성이부각되면서최소침습적금속판내고정술을상완골간부및원위경골골절등다양한부위에서사용하고있다. 14-16) 본연구의가설은쇄골간부골절에있어서최소침습적금속판내고정술이전통적관혈적정복및내고정술과동등한임상결과를보이거나더우수할것이라는것이다. 이번연구의목적은쇄골간부골절에있어서최소침습적금속판내고정술과관혈적정복및금속판을임상적및방사선적결과와비교하여평가하는것이다. 대상및방법 1. 연구대상단일연구기관에서 2011년 5월부터 2016년 8월까지수술적치료를시행한쇄골간부골절환자의연속되는증례들을대상으로후향적조사를시행하였다. 본연구는인제대학교해운대백병원임상시험심사위원회의승인을받고이루어졌다. 연구대상포함기준은다음과같다. 1) 20 mm 이상의전이성쇄골간부골절, 2) 불안정성분쇄골절, 3) 수상 2주이내의급성골절, 4) 골성장이완료된환자, 5) 수술후 6개월이상추시관찰한환자였다. 쇄골원위부골절, 금속정을이용한내고정술을시행한환자, 동측상지에다른골절이동반되어있는환자, 병적골절, 의무기록에서자료가충분치못했던환자는제외하였다. 상기기준을만족하는 40명의환자를조사대상으로설정하였다. 관혈적정복및금속판을이용한고정술을시행한경우는 21예 (1군), 최소침습적금속판고정술을시행한경우는 19예 (2군) 로평균연령은 41.5세 (17-85세 ) 였다. 수상기전은낙상 28예, 교통사고 15예, 직접타격 1예였다. AO/OTA 분류 17) 에따르면 15-A1 2예, 15-A2 1예, 15-A3 3 예, 15-B1 7예, 15-B2 11예, 15-B3 15예, 15-C1 1예였다. A B C D E F G H I J Figure 1. Surgical technique of minimal invasive plate osteosynthesis. (A) Patient positioning. Black arrow indicates padding on the interscapular space. (B) Marking of fracture configuration. (C) Plate positioning under fluoroscopic images. (D) Submuscular tunneling. (E) Use of reduction forces. (F) Reduced fragment. (G) Maintenance of clavicle length with a drill bit on each fragment. (H) Indirect reduction with a cortical screw. (I) Confirmation of alignment and fixation of 3 screws on each fragment. (J) A 2 cm-length separate skin incisions.

531 Surgical Treatment of Clavicle Midshaft Fractures: MIPO vs. ORIF 2. 수술방법및수술후처치수술은전문의 2명에의해시행되었으며 1명의경우관혈적정복술및금속판고정술만을시행하였고, 나머지 1명은두가지방법모두시행하였다. 최소침습적금속판고정술을 1차적으로시행하였으나피부절개전방사선투과영상에서골편의도수정복이잘되지않는경우관혈적정복술및내고정술을시행하였고 1예에해당하였다. 전예에서금속판은해부학적잠김금속판 (LCP superior clavicle plate; Synthes, Oberdorf, Switzerland) 을사용하였다. 고식적금속판고정술인관혈적정복및금속판고정술 (1군) 시에는전신마취하에환자를해변의자자세로앉힌뒤골절부를중심으로랑거선 (Langer line) 을따라피부절개를시행하고심부절개를하여골편을노출시켰다. 이때가능한한상쇄골신경을보존하였으며골막은골편부위만박리하였다. 해부학적정복후나선형 (spiral) 혹은사선형 (oblique) 골절의경우지연나사를이용하여고정한뒤잠김압박금속판을이용하여고정하였고, 횡 형 (transverse) 골절의경우피질골나사못을이용한역동적압박을한이후압박금속판을고정하였다. 근위부및원위부에각각최소 3개의나사못 6개의피질골을고정하였다. 최소침습적금속판고정술을시행한경우 (2군) 는관혈적정복술과같이준비를하였고양측견갑골사이에패딩을하여견갑골이뒤당김 (retraction) 되도록하였으며환측상지를조작하여놓은다음쇄골골절의정복을할수있도록하였다 (Fig. 1A). 방사선투과가능한수술대에서방사선투과기가머리쪽으로 10도, 0 도, 그리고다리쪽으로 45도돌릴수있도록하였다. 방사선투과기로골절부위및형태를확인하고골절의형태, 금속판의위치및절개부위를표시하였다 (Fig. 1B, 1C). 근위부는쇄골의전방경계 (anterior border) 를따라 2-3 cm 절개를하고넓은목근 (platysma) 을박리하였다. 원위부는삼각근 (deltoid) 과등세모근 (trapezius) 사이에서 2-3 cm 절개를가하였다. 근위부부위와원위부부위를연결하는쇄골골막바깥쪽, 근육하터널을만들어금속판을통과시킬준비를하였다 (Fig. 1D). 도수정복으로정복 A B C Figure 2. A 34-year-old male patient treated with conventional open reduction plating. (A) Preoperative x-ray. (B) Immediate postoperative x-ray. (C) Postoperative x-ray at 12 months follow-up.

532 Jin-Young Bang, et al. A B C Figure 3. A 35-year-old male patient treated with minimal invasive plate osteosynthesis. (A) Preoperative x-ray. (B) Immediate postoperative x-ray. (C) Postoperative x-ray at 12 months follow-up. 이만족스럽지못한경우정복겸자 (pointed reduction forceps) 혹은 Kapandji 기법을이용하여쇄골의정복및정렬을맞추고, 금속판을터널로통과시켜위치시켰다 (Fig. 1E, 1F). 쇄골정복시시상면앞뒤방향으로정복을확인하고쇄골길이의회복을확인한다음드릴비트를금속판의가장근위부및원위부에삽입하여임시고정을하였다 (Fig. 1G). 다리쪽 45도영상에서골절편의위아래관계를확인후피질골나사못을이용하여골편을간접정복하였으며 (Fig. 1H), 방사선투과기로정복상태를확인한뒤나머지나사못을고정하였다 (Fig. 1I). 이때사용한잠금압박금속판은 8 hole 금속판으로관혈적정복에서쓰던금속판에비해 1홀또는 2홀긴것을사용하였고, 금속판의굽힘 (bending) 을하지는않았다. 피부절개는나일론봉합사를이용하여봉합하였다 (Fig. 1J). 두군모두동일하게수술후팔걸이를적용하였으며견관절의수동적운동은급성기통증이완화된수술후 3일경부터시작하였고수술후 2주부터능동적운동을시행하였다. 3. 임상결과평가두군으로나누어비교-대조군연구를계획하였다. 나이, 성별, 체질량지수 (body mass index, BMI), 흡연및당뇨여부와같은인 구통계학적요소를조사하였다. 수술시간및수술중출혈량을 조사하였으며, 수술시간은피부절개부터봉합까지걸린시간을 기준으로삼았고, 출혈량은마취기록지에서기록된수치를확인 하였다. 159.82 mm 161.66 mm Figure 4. Measurement of clavicle shortening. Clavicle length ratio=a/b. 수술후임상적결과는수술후 6 개월째견관절운동범위및 University of California at Los Angeles (UCLA) 기능점수 18) 를사 용하였다. 견관절운동범위의평가는전방굴곡, 신전내회전및 외회전을각도기를이용하여환측을측정하였다. 수술후발생 한감염, 수술중신경손상, 나사못뽑힘 (pull-out), 고정실패, 재

533 Surgical Treatment of Clavicle Midshaft Fractures: MIPO vs. ORIF 수술등의합병증을조사하였다. 방사선적검사는수술후 2 주, 4 주, 8 주, 12 주, 16 주, 21 주, 26 주째에쇄골전후면사진및두부경 사면사진을촬영하였다. 수술후추시관찰한전후면및측면단 순방사선사진으로부터골유합률및골유합시기를확인하였다. 골유합의기준은관혈적정복술및내고정술의경우골절선이없 어지고골소주가골절부를통과하는양상이관찰될때로하였으 며 (Fig. 2), 최소침습적금속판고정술의경우두개의방사선 사진에서 3 면이상가골의연결 (bridging) 이관찰될때로삼았다 (Fig. 3). 저자들은수술후 6 개월방사선사진에서건측과환측의 쇄골길이를측정하여비율을계산함으로써쇄골단축정도를평 가하였다 (Fig. 4). 4. 통계적분석 수술방법에따라두군으로나누어인구통계학적요소, 골유 합률, 골유합기간, UCLA 점수를비교하였다. Kolmogorov- Smirnov 및 Shapiro-Wilk 검정을시행하여정규분포도를확인 하였으며이에따라연속형변수는독립표본 T 검정혹은 Mann- Whitney U- 검정을, 범주형변수에대해서는 chi-square 검정혹 은 Fisher 의정확검정을시행하였다. 통계적인분석은 PASW ver. 18.0 (IBM Co., Armonk, NY, USA) 소프트웨어를이용하였으며, Table. 1. Demographics of Participants Variable Group 1 (n=21) Group 2 (n= 19) p-value Sex (male/female) 16/5 18/1 0.101 Age (yr) 39.6±17.8 43.4±17.3 0.456 BMI (kg/m 2 ) 24.6±3.0 22.8±3.1 0.075 Smoking 6 (28.6) 5 (26.3) 0.873 DM 1 (4.8) 1 (5.3) 0.942 Injury mechanism 0.121 Slip down 15 10 TA 6 9 Direct blow 0 1 AO classification 0.457 A1 1 1 A2 1 0 A3 3 0 B1 2 5 B2 5 6 B3 7 7 C1 2 0 Values are presented as number only, mean±standard deviation, or number (%). Group 1, treated with conventional open reduction and plating; Group 2, treated with minimally invasive plate osteosynthesis; BMI, body mass index; DM, diabetes mellitus; TA, traffic accident. 분석에유의한 p 값은 0.05 이하로하였다. 결과 연구대상의인구학적구성은 Table 1 에정리되어있고, 나이, 당 뇨, 흡연항목에대한두군간의차이는없었다 (p>0.05). 환자들 의평균추시기간은 14.3 개월 (6-24 개월 ) 이었다. 평균수술소요 시간은 1 군의경우 98.8 분, 2 군의경우 80.7 분으로최소침습적금 속판고정술을시행한 2 군에서짧은수술시간을보였다 (p=0.039; Table 2). 수술중출혈량은각각 101.0 ml, 61.9 ml 로최소침습적 금속판고정술을시행한 2 군에서출혈량이적었다 (p=0.023). 방사선적결과로두군모두 2 차적인수술없이골유합을얻었 으며, 골유합기간은 1 군에서 14.9 주, 2 군에서 14.2 주로두군간의 유의성있는차이는없었다. 쇄골단축평가지표인환측의수술 후쇄골길이비율은 1 군에서 1.017, 2 군에서 1.026 으로두군모두 반대편쇄골길이의 3% 이내의길이를보였으며, 두군간의차이 는없었다. 견관절기능평가인 UCLA 점수는 1 군의경우 34.0 점, 2 군의경 우 33.7 점으로두군모두우수한결과를보였다. 수술후발생한 합병증중에서술후감염은두군모두보고되지않았다. 다만관 혈적정복술및금속판고정술을시행한 1 군에서나사못의뽑힘 경우가 2 예발생하였으나, 그정도가경미하여추시관찰후재수 술없이골유합을얻을수있었다. 고찰 이번연구에서쇄골간부골절에있어서최소침습적금속판내 Table 2. Clinical Features and Outcomes according to Surgical Method Variable Group 1 (n=21) Group 2 (n=19) p-value Time from injury to surgery (d) 3.8±3.8 3.3±2.7 0.658 Operation time (min) 98.8±29.6 80.7±23.2 0.039* Bleeding amount (ml) 101.0±58.4 61.9±43.6 0.023* Clavicle length ratio 1.017±0.067 1.026±0.072 0.663 Union time (wk) 14.9±7.5 14.2±3.6 0.713 UCLA score 34.0±1.5 33.7±2.2 0.658 Screw pull-out 2 0 0.168 Infection 0 0 Values are presented as mean±standard deviation or number only. *Statistically significant (p<0.05). Group 1, treated with conventional open reduction and plating; Group 2, treated with minimally invasive plate osteosynthesis; UCLA, University of California at Los Angeles.

534 Jin-Young Bang, et al. 고정술 (2군) 은관혈적정복및금속판내고정술 (1군) 과비교하였을때기능및유합기간에있어서동등한결과를보였고두방법모두기능에서도우수한결과를나타냈다. 최근쇄골간부에서보존적치료와금속판고정술을비교하는전향적연구에서금속판고정술이보존적치료에비해견관절의기능향상에도움이되고부정유합혹은불유합의빈도를낮춘다고하였다. 4,10) 이번연구에서도두방법모두우수한결과를보여금속판고정술의장점을뒷받침하는근거가될것이다. 쇄골간부골절에대한수술적방법중에서금속정을사용한내고정술은수술반흔의길이를줄이고연부조직손상을줄일수있다는장점이있다. 하지만금속정파손, 금속정의내측또는외측이동, 쇄골단축등의문제점을보였다. 19) 이번연구에서금속판을사용한고정한두방법모두쇄골단축은보이지않았으며, 최소침습적금속판고정술방법은수술반흔의길이를줄이고골절부위절개로인한추가적인연부조직손상을피할수있는특징이있다. 따라서최소침습적금속판내고정술은쇄골단축에있어서최소침습적내고정술중의하나인금속정내고정술의문제점을보완할수있을것으로생각한다. 최소침습적수술의장점이될수있는수술중출혈량은최소침습적금속판내고정술을시행한 2군에서적게나타났는데이는피부절개의최소화와연부조직박리및골막박리가관혈적정복에비해적게이루어졌기때문인것으로보인다. 최소침습적금속판내고정술의 2군에서수술소요시간이관혈적정복및금속판내고정술의 1군에비해짧은것으로나타났다. 하지만이번연구에서술자는두명으로한명은최소침습적및고식적금속판고정수술모두를, 나머지한명은고식적금속판고정술을시행하였으므로술자에따른차이의잠재적인오류를고려해야할것이다. 최소침습적금속판고정술술기에익숙해진경우연부조직박리및봉합에대한시간이줄어듦으로써전체수술시간의단축이가능할것으로해석할수도있을것이다. 한편본연구에서최소침습적금속판고정술을시도하였으나골편이근육사이에포착 (entrapment) 되어관혈적정복술로전환한경우가 1 예있었으며, 이는최소침습적도수정복이실패한경우에무리하게수술을진행하기보다는관혈적정복술로수술방법을전환하는치료전략의유연성이필요함을보여준다. 이번연구에서방사선노출시간, 급성기통증은비교하지못하였다는제한점이있는데, 방사선노출정도는최소침습적금속판내고정술의단점으로꼽히는데이에대한비교가없어아쉽다. 최소침습적수술일경우방사선조사를더많이하게되므로수술시이에대한주의와보호장치의착용이중요할것이다. 20) 쇄골의최소침습적금속판고정술에서급성기통증이상대적으로적을것이라는가설은이번연구가후향적연구라는점에서확인할수가없었다. 지금까지쇄골간부에서관혈적정복및금속판고정술과최소 침습적금속판고정술의비교연구는두건이발표되었고, 모두후향적연구이다. 21,22) 수술후임상기능에서는두방법모두우수한결과를보였다는공통된연구결과가있었고, 한연구에서는최소침습적금속판고정술에서골유합이빠르다고하였다. 21) 두연구모두수술시간에는차이가없다고하였고, 출혈량에대한결과는없었다. 이번연구의결과와함께정리하여본다면임상적기능은고식적금속판고정술과유사하에우수한결과를보이고, 골유합기간은고식적금속판에서와비슷하거나빠르다고할수있다. 이연구는한계점으로는후향적디자인의적은수의비교연구라는데있으며, 쇄골간부의골절치료시최소침습적금속판고정술의임상결과를정립화하기위해서는향후전향적연구및대규모환자군을통한검증이필요할것이다. 또한최소침습적금속판고정술에서기대할수있는적은절개길이및흉터에대한만족도에대한자료는추후연구를통한검증이필요할것이다. 두번째로는골유합기간을평가하기에는 4주간의방사선촬영간격으로인한정확한평가가이루어지지않았다는오류의가능성이있으나현실적으로더자주촬영하기에는어려움이있음을감안하여야할것이다. 결론 이번연구결과는전이성쇄골간부골절에서최소침습적금속판고정술과고식적방법인관혈적정복술및내고정술은모두기능및방사선적으로모두우수함을보였다. 따라서최소침습적금속판고정술은전이성쇄골골절의수술적치료법으로유용한한가지방법이될것이다. CONFLICTS OF INTEREST The authors have nothing to disclose. REFERENCES 1. Hill JM, McGuire MH, Crosby LA. Closed treatment of displaced middle-third fractures of the clavicle gives poor results. J Bone Joint Surg Br. 1997;79:537-9. 2. Nowak J, Holgersson M, Larsson S. Sequelae from clavicular fractures are common: a prospective study of 222 patients. Acta Orthop. 2005;76:496-502. 3. Ferran NA, Hodgson P, Vannet N, Williams R, Evans RO. Locked intramedullary fixation vs plating for displaced and shortened mid-shaft clavicle fractures: a randomized clinical trial. J Shoulder Elbow Surg. 2010;19:783-9.

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536 pissn : 1226-2102, eissn : 2005-8918 Original Article J Korean Orthop Assoc 2017; 52: 529-536 https://doi.org/10.4055/jkoa.2017.52.6.529 www.jkoa.org 쇄골간부골절에서잠김금속판을이용한치료 : 관혈적금속판고정술과최소침습적금속판고정술의비교 방진영 박병욱 서용민 김대욱 이동현 김영복 김영창 김지완 인제대학교의과대학해운대백병원정형외과학교실 목적 : 이번연구의목적은쇄골간부골절환자에서최소침습적금속판내고정술과고식적방법인관혈적정복술및금속판을이용한고정술의내고정술의수술후임상결과를비교해보고자하였다. 대상및방법 : 인제대학교해운대백병원에서 2011년 5월부터 2016년 8월까지쇄골간부골절로수술적치료를시행한환자를대상으로후향적연구를진행하였다. 전이가 20 mm 이상인경우, 수상후 2주이내의급성골절, 골의성장이완료된환자, 6개월이상추시관찰된환자를대상으로하였다. 환자의인구학적정보및수술시간, 골유합률, 골유합시기, 쇄골단축, University of California at Los Angeles 견관절기능점수, 합병증등을포함한임상결과를조사하였다. 21예의고식적금속판고정술군 (1군) 과최소침습적금속판고정술군 19예 (2군) 로나누어상기항목들을비교해보았다. 결과 : 골유합은모든예에서얻을수있었으며골유합시기는 1군에서 14.9주, 2군에서 14.2주로차이가없었다 (p=0.713). 두군모두우수한견관절기능점수를가졌다 (34.0 vs. 33.7, p=0.658). 2군에서적은출혈량및짧은수술소요시간을보였다재수술및감염은두군모두에서없었으며삽입물의파쇄도없었다. 골절된쇄골의건측쇄골에대한길이비율은 3% 이내를보여단축소견은보이지않았다. 결론 : 쇄골간부골절에서관혈적정복술및금속판고정술방법과최소침습적금속판고정술의두방법모두우수한임상적, 방사선적결과를보였다. 최소침습적금속판고정술은전이성쇄골골절의수술적치료법으로유용한한가지방법이될것이다. 색인단어 : 쇄골, 쇄골골절, 최소침습적금속판고정술, 금속판, 결과 접수일 2017 년 3 월 14 일수정일 2017 년 5 월 12 일게재확정일 2017 년 6 월 7 일책임저자김지완 48108, 부산시해운대구해운대로 875, 인제대학교의과대학해운대백병원정형외과학교실 TEL 051-797-0668, FAX 051-797-0669, E-mail bakpaker@hanmail.net 대한정형외과학회지 : 제 52 권제 6 호 2017 Copyright 2017 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.