196 Vol. 18 No., December 01 다는임플란트의직접압박고정법 (press fitting) 을선택함으로써고정력과내구성이획기적으로개선되었고, 최근에는가동형삽입물시스템인삼중구조인공발목관절 (three component total ankle arthropla

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Original Article pissn 178757 eissn 888551 J Korean Foot Ankle Soc 01;18(

.195 인공발목관절의임상시험가이드라인개발을위한문헌적고찰 박진오, 이모세, 이진우, 이수빈, 한승환 연세대학교의과대학정형외과학교실 Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty Jin Oh Park, Moses Lee, Jin Woo

of the total ankle replacement system for premarket approval. Materials and Methods: We selected and analyzed nine peerreviewed articles whose quality had been proven in a previous phase.

1 Original Article pissn eissn J Korean Foot Ankle Soc 01;18(): 인공발목관절의임상시험가이드라인개발을위한문헌적고찰 박진오, 이모세, 이진우, 이수빈, 한승환 연세대학교의과대학정형외과학교실 Review of Literatures for Development of Clinical Trial Guideline for Total Ankle Arthroplasty Jin Oh Park, Moses Lee, Jin Woo Lee, Soo Bin Lee, Seung Hwan Han Department of Orthopaedic Surgery, Yonsei University College of Medicine, Seoul, Korea Purpose: The purpose of this study is to develop guidelines for clinical trial of the total ankle replacement system for premarket approval. Materials and Methods: We selected and analyzed nine peerreviewed articles whose quality had been proven in a previous phase. Two investigators extracted parameters for guideline criteria, including number of cases, patient age, followup period, failure rate, radiographic osteolysis rate, residual pain rate, and percentage of satisfaction. In addition, the inclusion and exclusion criteria were analyzed and developed. Results: Eight level studies and one level II study were included. The average number of cases was 159 cases and the mean patient age was 6.5 years. The mean followup period was. years, ranging from two to nine. The average failure rate of total ankle replacement in mid to longterm followup was approximately 1% (%.%). The rate of osteolysis was approximately 18%. Residual pain was common (1.% 6%), but overall patient satisfaction was approximately 85.6% (67.5% 97%). Conclusion: The results could be used as criteria for designing the clinical studies, such as number of cases, patient age (over 60 years), and followup period (minimum two years). The clinical scoring system and 6item short form health survey (SF6) was the most commonly used method for clinical evaluation for total ankle arthroplasty. In addition, the overall results, including failure rate, osteolysis rate, and patient satisfaction, could be used as a parameter of guidelines for premarket approval. Key Words: Ankle, Arthritis, Ankle replacement arthroplasty, Clinical trial, Guideline 서론 폴리에틸렌경골인공관절과금속으로만든거골인공관절을이용한발목관절인공관절치환술은 197년에 Lord와 Marotte 1) 이처음시작하였으며, 말기발목관절염환자의치료로사용되었다. 이들을 1세대발목인공관절이라고하며, 고식적치료인발목관절유합술과경쟁하였으나기대이하의임상결과로인하여그사용이보편화되지는못하였다. ) 그이전에는인공고관절을발목에적 용하여인공관절술로대체하려는노력이있었으나모두실패하였고, 1세대인공관절치환술의경우도 7예중 7예에서만족할만한결과를얻는등그성적은좋지못하였으나발목인공관절의시작이라는점에서의의가있다고할수있다. ) 이를토대로디자인과생역학적모델이개선된 세대인공발목관절치환물이개발되었는데이전의인공관절에비해해부학적으로주변인대의손상을최소화하면서최대한의운동범위를구현하되모든운동범위에서안정성을얻을수있도록디자인되었다. 특히시멘트고정보 Received October 6, 01 Revised October 9, 01 Accepted October 9, 01 Corresponding Author: Seung Hwan Han Department of Orthopaedic Surgery, Gangnam Severance Hospital, Yonsei Univer sity College of Medicine, 11 Eonjuro, Gangnamgu, Seoul 1570, Korea Tel: , Fax: 85759, osmedic@yuhs.ac. Financial support: This study was supported by the grant of the Korea Food and Drug Administration. Conflict of interest: None. Copyright c01 Korean Foot and Ankle Society. All rights reserved. CC This is an Open Access article distributed under the terms of the Creative Commons Attribution NonCommercial License ( bync/.0) which permits unrestricted noncommercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

2 196 Vol. 18 No., December 01 다는임플란트의직접압박고정법 (press fitting) 을선택함으로써고정력과내구성이획기적으로개선되었고, 최근에는가동형삽입물시스템인삼중구조인공발목관절 (three component total ankle arthroplasty) 이개발되어사용되고있다. ) 그러나개발자의의도와달리인공관절물주위의해리현상 (osteolysis), 수술후잔여통증등합병증발생이빈번하여퇴출된시스템도적지않다. 따라서다양한인공발목관절의재료와디자인의개발에도불구하고임상적결과에대한논란은지속되고있으며, 실제환자에임상적으로인공발목관절을적용하기에앞서새로이개발된인공발목관절의임상효과를증명할수있는체계적인임상시험계획과가이드라인이요구되고있다. 이에본연구에서는새로이개발된인공발목관절의안정성, 유효성검증을위한체계적인임상시험가이드라인을이전의임상시험과문헌고찰을통해제시하고자한다. 대상및방법 임상시험가이드라인개발에기초가될수있는이전발표논문및임상시험관련자료를수집하여다음각항목으로분류하였고, 국내와국외가이드라인및기존임상시험자료등을참고하여분석하였다. 최근 10년안에 PubMed에등재된논문중개발자가직접저술한논문은제외하였으며, 단순증례보고형식의논문이아 닌 50명이상의대규모임상연구중개별인공관절기기에대한추적관찰결과가보고된논문을위주로문헌을선택하였다 (Table 1). 1) 1. 국내인공관절허가현황및사용현황현식품의약품안전처의료기기품목분류상인공발목관절해당품목정의를조사하고이에따른국내인공발목관절허가및사용현황, 임상시험대상의료기기여부를확인하였다.. 국내외임상시험현황분석인공발목관절관련과거 10여년간발표되었던인공발목관절과관련된대표적임상논문자료를분석하여가이드라인작성에유용한항목을도출하였다 (Table ). 1) 각연구에사용되었던임상시험항목을다음기준에의하여분석하고임상시험가이드라인에포함시켰다. 1) 임상시험대상및제외기준 (inclusion criteria and exclusion criteria) 분석인공발목관절임상시험에참여한환자의포함기준및제외기준을분석함으로써정확한인공발목관절의기능을평가할수있는환자군선택에대한고찰을시행하였다. 본분석항목에서는인공 Table 1. Patient Number, Age, and Followup Period of Selected Articles Study First author Level of study Prosthesis Cases (n) Mean age (yr) Mean followup (yr) Mean Hurowitz 6) Knecht 7) Anderson ) Valderrabano 10) Wood 1) Saltzman 8) Bonnin 5) Schweitzer 9) Valderrabano 11) II Hintegra Refer to Table for the company information of prosthesis except in the case of (DePuy, ). Table. Survivorship and Clinical Results of Implants Study First author Prosthesis Failure (%) Osteolysis (%) Residual pain (%) Satisfaction (%) Mean Hurowitz 6) Knecht 7) Anderson ) Valderrabano 10) Wood 1) Saltzman 8) Bonnin 5) Schweitzer 9) Valderrabano 11) Hintegra Values are presented as mean. Refer to Table for the company information of prosthesis except in the case of (DePuy, ).

3 Jin Oh Park, et al. Clinical Trial Guideline of Total Ankle Arthroplasty 197 발목관절의임상결과에영향을줄수있는환자군들의특징과개체들을분석하였다. ) 임상시험기간및대조군선정인공발목관절의임상시험평가기간은최소성능평가를위한평가기간과장기간의기능평가, 인공발목관절수명과연관되는내용으로각각의기간에대한평가의미와분석항목등을도출해내었다. 또한시험대상인공발목관절의적절한대조군은어떻게설정되었는지를비교검증문헌고찰을통해살펴보았다. ) 임상시험평가항목분석인공발목관절기능을임상적으로평가할수있는다양한평가방법중주로사용되는항목들을기존의문헌을분석하여도출하였고, 향후임상시험에서인공발목관절의안정성및유효성평가를위해반드시포함시켜야할일차평가지수와이차평가지수항목을도출하였다. ) 방사선학적평가항목분석인공발목관절수술이후치환물의위치및골용해정도를평가하는방법에대하여사용되는기준을분석하여제시하였다. Table. Classification of Total Ankle Replacement Implant in Korean Food and Drug Admisitration Item category code B B Class Item name Prosthesis, ankle, internal total Prosthesis, ankle, internal total biodegradable 5) 선정된임상시험평가항목분석에대한통계분석방법선정된논문에서주로사용되는평가방법에대하여, 사용가능한통계기법과이에대한활용법에대하여예를들어제시하였다. 결과 1. 국내인공발목관절허가현황및사용현황의료기기품목및품목별등급에관한규정 (01년 10월 1일개정 ) 에의하면인공발목관절은두가지품목분류로허가되어현재시판되고있다 (Table ). 발목관절부의관절성형술에사용하는임플란트로서인공경골부, 인공거골부등이개별또는한벌로구성될수있다. 안정성이확인된재질로구성되어있으며표면처리 (porous coating, 산환막등 ) 된경우는 등급으로분류되며, 안전성이확인되지않은재료 ( 생체재료, 흡수성재료등 ) 및특수표면처리한경우는 등급으로분류된다. 인광관절과관련된디자인, 즉이중구성인공관절 (two component system), 삼중구성인공관절 (three component system) 등일반적으로임상에서많이통용되는분류보다는인공관절에사용된금속의재료에따라분류가되고있다. 특히안정성이확인되지않은재료 ( 생체재료, 흡수성재료등 ) 가사용된인공관절은특수재질인공발목관절로분류하여임상시험을의무화하고있다. 현재국내에서제조되고있는인공발목관절은없으며, 모두수입하여사용되고있다. 초기 시스템은현재수입이되지않고있으며, 현재 Hintegra (Newdeal, Lyon, France), (Tornier, Edina, MN, ), Mobility (DePuy, Warsaw, IN, ), Zenith (Corin, Cirencester, England) 등 개의회사제품이사용되고있다 (Table ). 현재국내에서사용되고있는모든인공발목관절은품목분류상 Table. List of Available Total Ankle Replacement System in Current Market Market Name Company Nation Component Class Domestic International Hintegra Mobility Zenith INBONE BuechelPappas Ecplipse TARIC German Ankle system ESKA BOX Albatros Ramses Ankle Evolution CCI Evolution Alphamed Orthner TNK Trabecular Metal Newdeal Tornier DePuy Corin Wright Medical Endotec Integra Life Science Implantcast GmbH Arge Medizintechnik ESKA Implant Finsbury Orthopaedics Groupe Lepine Maitrise Orthopatique Biomet Van Straten Medical Alphamed Kyocera Zimmer Small Bone Innovation France EU England Germany Germany Germany England France France Netherlands Netherlands Austria Japan

4 198 Vol. 18 No., December 01 일반인공발목관절에해당되고, 특수재질인공발목관절항목으로허가되어사용되는인공관절은없다. 국내에수입되지않고외국에서사용되고있는인공발목관절제품을분석한결과, 일본에서사용중인 TNK 시스템 (Kyocera Medical Corp., Kyoto, Japan) 이 titanium 및 cobaltchrome 등을사용하는일반적인인공관절과는달리 ceramic을사용하는제품으로특수재질인공발목관절로분류할수있으며, hydroxyapatite가표면처리된 시스템 (Small Bone Innovation, Morrisville, PA, ) 의경우도특수표면처리로인하여 등급제품으로분류될수있다. 그외제품들은 등급인일반인공발목관절에해당된다 (Table ).. 국내외임상시험현황분석 1) 임상시험대상및제외기준문헌고찰결과대상자의평균연령은약 6.5세였으며 ( 89 세 ), 원발성또는외상후발목관절염환자중말기발목관절염환자가인공발목관절의주적용대상환자군이었다. 자가면역성발목관절염및대사성발목관절염은임상연구대상에서포함되는경우가적었다. 임상시험대상자선정기준에서통증에대한선정기준은모든문헌에서관찰되었으며, 6개월이상의일반적인보존적치료에도통증이조절되지않는경우임상시험대상자로선정되었다. 방사선학적선정기준으로는말기관절염이주대상질환으로선정되었으며, 이는 Takakura 발목관절염분류상 IIIb, 또는 Kellgren & Lawrence grade III, 이상의방사선학적관절염소견에해당된다. 1,1) 통증이심하나방사선학적분류가경미한경우임상시험대상에서제외되었다. 수술전골성숙도가낮은경우나골다공증이있는환자는인공관절의생존에영향을줄수있으므로제외하는경향이많았다. 또한정면측정사진에서발목관절의관상면변형이 0 o 5 o 이상내반또는외반되어있는경우임상시험대상에서제외되었다. 주된제외기준으로는발목관절주위활동성감염또는심부감염이있는경우, 발목뼈의무혈성괴사등으로뼈의실체가남아있지않는경우등이있었다 (Table 5). ) 임상시험기간및대조군선정임상시험기간은인체에삽입된인공발목관절의안정성과유효성을평가하는최소기간으로인공관절의초기생존율평가, 장기생존율평가에중요한지표가된다. 임상사용허가를위한평가기간은초기생존율을반영할수있는단기추적관찰을요하며, 문헌조사결과최소단기추적관찰은.5년, 중기추적관찰기간은 6년, 장기추적관찰기간은 10년이상으로나타났다. 본연구에인용된문헌의경우평균추적관찰기간은약.년 ( 9년) 으로나타났고, 최소 년이상의추적관찰을시행한것으로나타났다. 대조군의경우대부분의논문에서단일추적관찰결과를보고하여자료가많지않았으나, Saltzman 등 8) 은전향적대조군연구에서는발목관절염에대한발목관절유합술을대조군으로설정하여두군간의비교를통해인공발목관절의우수성을검증하였다. 특정두제품간의전향적비교연구는현재까지진행되지않은것으로조사되었다. ) 임상결과평가항목선정된문헌을분석한결과인공발목관절치환술이후사용되는공통된임상평가시스템은없는것으로나타났다. 그러나유효성에대한주된평가항목으로통증및기능을반영하는객관적평가지표와환자의정신적만족, 삶의질향상등을반영하는주관적평가지표가대부분의임상연구에서공통적으로사용되었다. 또한 visual analogue scale과같은단순한항목을측정하여수술전후임상결과를비교하기보다는다양한지표를종합하여평가하는 scoring system을이용하였으며, Kofoed ankle score system, 15) American Orthopaedic Foot and Ankle Society (AOFAS) anklehindfoot scale, 16) BuechelPappas score, 17) ankle osteoarthritis scale, 18) foot and ankle disability index 19) 등다양한종합임상평가방법들이사용되었다. 환자만족도및환자삶의질평가항목또한대부분의연구에서같이시행되었으며, 종합임상평가항목들과는달리 6item short form health survey (SF6) 0) 와같이널리입증된삶의질평가도구가공통적으로대다수논문에서사용되었다. Table 5. Inclusion and Exclusion Criteria of Clinical Trial Protol in Total Ankle Replacement System Inclusion criteria Exclusion criteria Severe pain, loss of function related with ankle joint End stage primary osteoarthritis, posttraumatic arthritis (Takakura stage IIIb,, Kellgren & Lawrence grade III, ) At least 6 months of conservative care with confirmation of medical record, Xray, medication record Low bone maturity Active or deep infection of ankle joint Lower extremity peripheral arterial occlusive disease Uncontrolled diabetes mellitus History of ankle arthrodesis Hindfoot angulation more than 5 o /forefoot malalignment inhibiting plantigrade foot Obesity (>115 kg) Avascular necrosis of distal tibia

5 Jin Oh Park, et al. Clinical Trial Guideline of Total Ankle Arthroplasty 199 안정성평가항목으로는인공발목관절수술이후발생하는감염률, 초기생존율, 재수술률등의항목이사용되었으며, 현재사용되고있는인공발목관절의실패율은평균 1% (%.%) 로나타났다. 인공발목관절의생존율의경우기관및인공발목관절종류에따라차이가있으나대략적으로단기추시결과평균 85% 이상이었다. ) 방사선학적평가항목분석방사선학적지표는 Hintermann 등 1) 이제시한지표들을주로사용하였다. 경골치환물의위치평가로경골삽입물에대하여전후면사진상경골의축과경골삽입물이이루는 α각, 측면사진상경골의축과경골삽입물이이루는 β각이사용되었으며, 측면사진상거골의위치평가를위한 γ각을정의하였다. 이들지표와함께삽입물주변의골음영변화를측정하여골용해 (osteolysis) 여부도측정하였는데, 조사된문헌상약 18% (1% 6%) 에서골용해가관찰되는것으로나타났으며, 골용해가반드시수술실패와연관되지는않았다. 5) 선정된임상시험평가항목에대한통계분석방법예시제안주된일차유효성평가항목은종합임상평가항목이주로사용되었으므로, 연속변량으로선정된점수비교의경우독립된평가자에의해시험군과대조군피험자들이기록한점수의평균을비교하고, 독립이표본 t검정 (two sample ttest) 또는 Wilcoxon 순위합검정 (Wilcoxon rank sum test) 을이용하여분석하는것이권고된다. 추가적인유효성평가기준으로 SF6, 설문점수등은기저값 (baseline) 대비일정시점에서의변화율이시험군과대조군간유의한차이가있는지에대해공변량분석 (analysis of covariance, ANCOVA) 을이용하여검정하는것이권고된다. 이때기저값은공변량으로한다. 정규성을만족하지못하는경우에는반응변수에적절한변환을수행한후에공변량분석을실행하는것이권고된다. 고찰 인공발목관절수술은말기발목관절골관절염또는이와비슷한대사성관절염, 자가면역관절염등다양한원인의관절염에의해방사선학적으로관절파괴가심하면서통증이심한경우시행되는수술이다. 이전의고식적발목관절유합술의경우운동제한과주변관절의관절염파생등의합병증으로인해현재점차인공발목관절수술로그추세가바뀌고있다. 임상시험에있어대상질환의선택은해당의료기기가주로적용될대표질환으로선택되어야하며, 일차성또는외상성말기발목관절염이대부분의문헌에서인공발목관절의대상질환으로선정되어있었다. 일부문헌에서대사성또는자가면역발목관절염이포함되어있기는하나, 관절염의원인이나진행양상이일차성발목관절염과달라그원인에따 라다양한결과가예상될수있다. 6) 따라서인공발목관절의다기관전향적연구가없는상태에서다양한원인에의한관절염환자를대상환자로포함하는것은임상시험에예기치않은결과를초래할수있으므로임상시험대상자선택에있어신중을기해야한다. 임상시험에있어임상시험기간은대상환자선정과더불어매우중요한부분이며, 적용된의료기기가충분히그성능을발휘하고합병증의발생이어느정도안정된시기를선택해야된다. 인공관절의내구성을시험하는것이목적이라면중장기적인추적관찰이필요할수있겠으나, 일반적으로안전성유효성의검증이필요한단계에서는단기추적관찰기간만으로충분히자료의분석이가능하다고본다. 본연구에사용된문헌의경우에도단기부터중장기까지다양한기간을가지고인공발목관절을분석하였으나대략적인인공발목관절의성능과합병증빈도의측정은 년정도의단기추적관찰기간에서시행되었으며, 이기간내에삽입된인공발목관절의생존율, 재수술률, 감염률등을측정하여안정성및유효성의기초자료로적용한것으로나타났다. 임상적용이시작된인공발목관절의경우, 평균 8년이상의장기적인추적관찰결과가보고되고있으나인허가를위한임상평가보다는사후관리및장기생존율평가측면에서지속적으로성능관리를하는데의미가있다고하겠다. 이전주요논문의수술전후임상결과성적은대조군없이특정인공발목관절을적용후특정기간이후의절대평가로해당의료기기의유효성을평가하였다. 생존율과재수술률도현재시판되고있는제품의최소한의성적이상이도출될수있는기준을정하여평가하는방법을사용할수있다. 대조군임상연구를계획하는경우현재시판되고있는제품이나특정기준치료방법을선정하여동등성, 비열등성또는우월성임상시험기법으로대상인공발목관절의임상성적을증명할수있다. 대조군의설정에있어연구자의의도에따라다양한방법과이에따른통계적분석으로결과가도출된다. 수술전후의임상결과를비교하는경우특정향상치를설정하여임의로설정된통계검증범위에서향상도를측정할수도있다. 또한, 특정수술법이나시판중인인공발목관절을대조군으로설정하는경우비열등성, 우월성및동등성임상시험으로계획하여일정폭 (margin) 이상의임상결과향상을증명하는방법도현재비교적많이사용되고있는임상시험기법이라할수있다. 특히, 임상결과차이의인정폭은많은문헌고찰과관련전문가들의의견조율에의해결정되는사항으로임상시험대상자수와통계분석기법을결정하는매우중요한지표이므로임상시험계획시연구자는반드시이에대한정의와근거가준비되어야한다. 인공관절수술이후환자의임상향상정도의평가로단일항목측정보다는다양한종합임상평가방법을이용한임상연구가대부분시행되었다. 약물치료임상에서특정항목의개선만을일차평가지수로선택하는것과는달리통증, 기능, 방사선지표, 관절운

6 00 Vol. 18 No., December 01 동범위등의항목을측정하여종합적으로평가하는방법을선택하였으며, 평가분석법마다조금씩차이는있으나임상시험자가관심을가지는항목의비중에따라다양한평가법이선택되는경향이있는것으로나타났다. 인공무릎관절이나인공엉덩이관절에서는현재대부분의연구에서학회에서인정되는하나의평가법으로연구가진행되고있으나, 인공발목관절수술은공통된평가법이없는것이문제로나타나향후이와관련된연구가진행되어야할것으로판단된다. 이들평가항목은반드시이전의통계관련분석에서유용성 (validity) 과신뢰도 (reliability) 가증명되어야하며, 19,,) 가장흔히사용되는 AOFAS scale은상기유용성과신뢰도가증명되지않은임상측정법으로향후사용에주의가필요하다고알려져있다. 또한대부분이외국어로된평가방법이어서환자의설문조사를위해이를한국어로번역하는경우이에대한적절성평가도선행되어야한다. ) 현재많은유용성과신뢰도가증명된평가방법이다양한임상시험에서삶의질평가방법으로사용되고있으나, 유료서비스가많고사용전개발자의허락이필요하며임의사용에주의를요한다. 투시방사선사진상적정한인공물위치를평가하기위하여 Hintermann 등 1) 은다음의기준을제시하였다. 경골치환물의위치평가로경골삽입물에대하여전후면사진상경골의축과경골삽입물이이루는 α각, 측면사진상경골의축과경골삽입물이이루는 β각이사용되며, 측면사진상거골의위치평가를위한 γ각을정의하였다. 이기준은 Hintegra 인공발목관절에주로특화되어사용되는기준이나이와비슷한 나 인공발목관절에도적용이어느정도가능하다. 그러나인공발목관절의디자인이다른경우이에대한방사선학적지표는보정이필요하다. 전반적인문헌고찰결과정상적인경골치환물의위치는 85 o <α<95 o, 80 o < β<90 o 를이뤄야하며, 각의변화가 o 를초과하거나연속적인방사선투과성선이 mm보다긴경우에는경골인공물의해리를의심해야한다. 거골인공물의해리는 γ각의변화가 5 o 를초과하거나길이의변화가 5 mm를초과한경우로정의한다. 또한방사선학적해리구역도인공발목관절마다발생하는위치가상이하나보편적으로적용이가능한해리구역에대한공통된의견은없는것으로조사되었으며, 이에대하여공통화된방사선학적측정지표가제시되어야할것으로판단된다. 결론 본연구에의해분석된이전의인공발목관절술의임상연구결과중대상환자수, 나이및추적관찰기간등은안정성유효성검증을위한임상시험가이드라인의참고자료로활용될수있다. 특히인공발목관절임상시험의주된임상시험대상환자군은 60세이상의일차또는외상성말기발목관절염환자였으며, 최소관찰기간 으로는 년이상이필요한것으로나타났다. 주된임상평가자료로는다양한종합임상관찰평가항목이사용되었으며, 그외에환자만족도평가인 SF6 지표와통증점수등도추가적인평가항목으로주로사용되었다. 방사선학적지표는많은논문에서사용이되었으나아직공통된평가방법은없는것으로나타났다. 인공관절주위골해리현상등의자료는향후새로운인공발목관절인허가시상대적인비교지표로사용이가능할것으로생각된다. REFERENCES 111 Lord G, Marotte JH. Total ankle prosthesis. Technic and 1st results. Apropos of 1 cases. Rev Chir Orthop Reparatrice Appar Mot. 197;59:1951. Gougoulias NE, Khanna A, Maffulli N. History and evolution in total ankle arthroplasty. Br Med Bull. 009;89: Cracchiolo A rd, Deorio JK. Design features of current total ankle replacements: implants and instrumentation. J Am Acad Orthop Surg. 008;16:500. Anderson T, Montgomery F, Carlsson A. Uncemented total ankle prostheses. Three to eightyear followup of fiftyone consecutive ankles. J Bone Joint Surg Am. 00;85: Bonnin M, Judet T, Colombier JA, Buscayret F, Graveleau N, Piriou P. Midterm results of the Total Ankle Prosthesis. Clin Orthop Relat Res. 00;(): Hurowitz EJ, Gould JS, Fleisig GS, Fowler R. Outcome analysis of agility total ankle replacement with prior adjunctive procedures: two to six year followup. Foot Ankle Int. 007;8: Knecht SI, Estin M, Callaghan JJ, Zimmerman MB, Alliman KJ, Alvine FG, et al. The total ankle arthroplasty. Seven to sixteenyear followup. J Bone Joint Surg Am. 00;86: Saltzman CL, Mann RA, Ahrens JE, Amendola A, Anderson RB, Berlet GC, et al. Prospective controlled trial of total ankle replacement versus ankle fusion: initial results. Foot Ankle Int. 009;0: Schweitzer KM, Adams SB, Viens NA, Queen RM, Easley ME, Deorio JK, et al. Early prospective clinical results of a modern fixedbearing total ankle arthroplasty. J Bone Joint Surg Am. 01;95: Valderrabano V, Hintermann B, Dick W. Scandinavian total ankle replacement: a.7year average followup of 65 patients. Clin Orthop Relat Res. 00;(): Valderrabano V, Pagenstert G, Horisberger M, Knupp M, Hintermann B. Sports and recreation activity of ankle arthritis patients before and after total ankle replacement. Am J Sports Med. 006;: Wood PL, Prem H, Sutton C. Total ankle replacement: mediumterm results in 00 Scandinavian total ankle replacements. J Bone Joint Surg Br. 008;90: Takakura Y, Tanaka Y, Kumai T, Tamai S. Low tibial osteotomy for osteoarthritis of the ankle. Results of a new operation in 18 patients. J Bone Joint Surg Br. 1995;77: Kellgren JH, Lawrence JS. Radiological assessment of osteo

7 Jin Oh Park, et al. Clinical Trial Guideline of Total Ankle Arthroplasty 01 arthrosis. Ann Rheum Dis. 1957;16: Kofoed H. Cylindrical cemented ankle arthroplasty: a prospective series with longterm followup. Foot Ankle Int. 1995;16: Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the anklehindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 199;15: Buechel FF, Pappas MJ, Iorio LJ. New Jersey low contact stress total ankle replacement: biomechanical rationale and review of cementless cases. Foot Ankle. 1988;8: Domsic RT, Saltzman CL. Ankle osteoarthritis scale. Foot Ankle Int. 1998;19: Martin RL, Irrgang JJ. A survey of selfreported outcome instruments for the foot and ankle. J Orthop Sports Phys Ther. 007;7:78. Ware JE Jr, Sherbourne CD. The MOS 6item shortform health survey (SF6). I. Conceptual framework and item selection. Med Care. 199;0:78. Hintermann B, Valderrabano V, Dereymaeker G, Dick W. The HINTEGRA ankle: rationale and shortterm results of 1 consecutive ankles. Clin Orthop Relat Res. 00;():5768. Roos EM, Brandsson S, Karlsson J. Validation of the foot and ankle outcome score for ankle ligament reconstruction. Foot Ankle Int. 001;:7889. Lee KM, Chung CY, Kwon SS, Sung KH, Lee SY, Won SH, et al. Transcultural adaptation and testing psychometric properties of the Korean version of the Foot and Ankle Outcome Score (FAOS). Clin Rheumatol. 01;:150.

세라뉴스-2011내지도큐

세라뉴스-2011내지도큐 2 2 8 17 18 22 23 24 Heinrich Wecker 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 예정된 이벤트 증례2 : 세라믹-폴리에틸렌 고관절 치환술후 발생한 비구-대퇴 해리로 세라믹-세라믹 관절면을 사용하여 재수술 진단 : 고관절 통증으로 내원한 65세 여자환자, 20년전 세라믹-폴리에틸