1. 서론 ··········································································································· 1
1.1 평가배경 ··················································································································· 1
1.2 의료기술 개요 및 관련 현황 ··················································································· 3
2. 평가방법 ··································································································· 15
2.1 개요 ·························································································································· 15
2.2 문헌검색전략 ··········································································································· 15
2.3 개별 문헌의 질 평가 ································································································ 20
2.4 의료기술의 근거의 판정기준 ·················································································· 21
2.5 자료추출 ··················································································································· 22
2.6 자료분석 방법 ·········································································································· 23
3. 평가결과 ··································································································· 24
3.1 개요 ·························································································································· 24
3.2 안전성 결과 ·············································································································· 27
3.3 유효성 결과 ·············································································································· 27
4. 결론 ··········································································································· 40

고관절 부위의 고난이도 수술에서 환자 맞춤형 3D 프린팅 모형을 이용한 수술 시뮬레이션은 고관절 부위의 고난 이도 수술 환자를 대상으로 수술 전 3D 프린팅 기술을 이용하여 제작한 3차원 골모형을 이용하여 수술 시뮬레이 션을 수행함으로써 수술 결과 개선에 도움을 주기 위한 기술로, 의료법 제53조 및 신의료기술평가에 관한 규칙 제3조의 규정에 따라 2022년 11월 16일 신의료기술평가로 신청되었다. 2022년 제12차 신의료기술평가위원회 (2022. 12. 23.)는 동 안건을 정형외과(고관절 수술분야 및 3D분야) 4인, 영상의학과(근골격영상 및 3D분야) 2 인, 근거기반의학 1인의 총 7인의 전문가로 구성된 소위원회를 통해 안전성 및 유효성을 평가하도록 심의하였다. 신청 당시 동 기술은 ‘모의수술을 위한 환자 맞춤형 3차원 뼈모델(Patient-specific 3D bone model for surgery simulation)’이라는 명칭으로 신청되었으나 임상에서 사용하는 표준 용어 등을 고려하여 소위원회 논 의 하에 의료행위에 부합하도록 최종 기술명을 변경하였다. 고관절 부위의 고난이도 수술 환자에 대해서는 신청자가 제시한 ⅰ) 고관절 변형(발달성 고관절 이형성증 의 후유증, 감염성 고관절염의 후유증, 고관절 골성 유합, 비구골절 등으로 인한 외상후성 골관절염, 골반 및 고관절 내 방사선 치료의 후유증 중 1개 이상에 해당)으로 인한 이차성 고관절염으로 인공 고관절 전치 환술을 고려 중인 환자, ⅱ) 인공 고관절 전치환술 후 심한 골용해로 인공 고관절 재치환술을 수행하기 어 려운 환자, ⅲ) 골반골, 근위대퇴골의 분쇄골절 환자로 정복과 내고정술을 하기 어려운 환자, ⅳ) 골 종양 이 발생하여 인공대치물로 치료가 필요한 환자로 정의하였다. 고관절은 비구(Acetabulum)와 대퇴골 근위부(Proximal Femur)로 이루어지는 관절로, 체중 부하 전달과 굴곡 -신전, 외전-내전, 회전 등 광범위한 관절 운동 기능을 가능하게 한다(대한정형외과 학회, 2020). 이러한 고관절 부위에 골절 혹은 골관절염 등의 질환이 발생하면 통증이 유발되거나 운동기능이 제한되어 하지 근력의 약화, 일상생활 능력의 장애를 초래하며 삶의 질에 부정적인 영향을 미칠 수 있으며, 골 종양이 발생하면 주변 조직을 침범 혹은 전이를 일으켜 사망에 이르도록 할 수 있어 치료가 필요하다(권영삼&김희중, 2009; 이성원, 2002; 대한정형외과 홈페이지).