ROSA® Knee System은 정형외과 의사가 인공관절 무릎수술 시 환자의 슬관절 구조를 화면에 3D로 재구성하거나 영상정보 없이도 화면에서 연조직의 상태를 구현하여 임플란트의 삽입 위치를 사전에 계획하고, 개별 환자의 관절 구조를 고려한 수술 진행과 슬관절 절제를 돕는 로봇 플랫폼입니다
*측정값의 정확도: ±2° 로봇팔 위치 정확도: < 0.75mm RMS
로봇 인공관절 수술이란?
ROSA 란?
Surgeon-Centered : 의사 주도
정형외과 의사 개인의 노하우와 수술 테크닉을 발휘하면서 로봇 수술이 가능합니다.
정량화된 정보: 연조직을 객관적으로 측정하고 뼈절삭에 앞서 균형잡힌 각도, 위치, 방향의 임플란트 삽입을 사전 계획합니다.
짧은 시간 안에 초기 러닝커브를 극복할 만큼 수술이 쉽습니다.1,2
향상된 슬관절전치환술 전문성: 로봇의 지원을 통해 의사의 스트레스와 긴장도를 낮춥니다. 3
짐머바이오메트 브랜드의 임플란트 사용: Persona® The Personalized Knee® 4-7, Vanguard® Knee System 8 , NexGen® Complete Knee Solution 9
Accurate: 정확도
최근 생체내 연구 보고에 따르면:
ROSA plan vs. 수술 후 슬관절 절삭 결과값의 차이는 평균 1° 미만, 1mm 미만(표준편차 1미만)이었으며,
ROSA plan vs. 수술 후 HKA(hip-knee-ankle) 각도 값의 차이는 평균 1.2° ± 1.1° 이었습니다.
전통적 수술법과 비교하여 향상된 정밀도와 정확도11
기존 무릎전치환술 기구를 사용한 수술과 로봇수술을 비교한 카데바 연구에 따르면, 전통적 방식으로 진행된 무릎수술의 25%에서 ±3°각도의 정렬 오차가 있던 반면, ROSA Knee 로봇 수술을 통한 모든 로봇 사례들은 사전계획된 각도 정렬값과 비교하여 오차범위가 ±3° 이내였습니다.
Efficient: 효율성
효율적인 화면 옵션: 기본 옵션(Image-free)과 이미지 기반(Image-based) 옵션 중 하나를 선택할 수 있습니다. 기본적으로는 이미지 없이도 효율적으로 프로세스를 진행시킬 수 있으며, 2D 이미지를 직관적인 3D화면으로 변환하여 활용하기도 합니다.
Data-Driven: 데이터 기반
중요한 순간, 최선의 의사결정을 내리기 위해서는 객관적 데이터에 기반한 사고가 필요합니다.
짐머바이오메트는 최첨단 통합 디지털 기술력, 로봇공학 및 임플란트 솔루션 제품군의 잠재력을 발휘하기 위하여 다이내믹하게 변화하고 있습니다.
로봇 수술절차
사전 계획
- 수술 전 의사의 결정에 따라 X-ray 혹은 MRI 촬영을 통해 환자의 무릎구조를 직관적인 3D화면으로 재구성합니다.
- 기본적으로는 이미지 없이도 수술 당일 효율적으로 프로세스를 진행시킬 수 있습니다(Image-free)
랜드마킹
- 대퇴골 및 경골 포인트를 획득하여 소프트웨어에 등록시킵니다.
- 최소한의 포인트로 환자 다리 정렬에 필요한 핵심적 기계적인 축(Mechanical axis)이 계산됩니다.
계획 및 평가
- ‘초기-수술 중-최종’ 단계를 거쳐 환자 무릎 특성(운동 범위, 정렬, 이완, 공간 등)을 실시간 수치화하고 저장합니다.
- 최적의 임플란트를 선택하여 사이즈를 조정, 뼈 절삭량을 계획합니다.
수술 (뼈 절삭 및 임플란트 삽입)
- 의사의 주도 하에 로봇 팔을 움직여 계획에 따른 수술을 진행합니다.
- 수술절차에 따라 자동모드-공동모드-고정모드가 작동됩니다.
- 최적의 인공관절을 삽입합니다.
수술 후 평가
- 최종적인 슬관절 평가로 뼈 절삭량 및 균형정도를 확인합니다.
관련 자료 및 논문
Individualized alignment and ligament balancing technique with the ROSA® robotic system for total knee arthroplasty.
Rossi SMP, Benazzo F. Int Orthop. 2023 Mar;47(3):755-762. doi: 10.1007/s00264-022-05671-z. Epub 2023 Jan 4. PMID: 36596998.
Key Takeaway: The ROSA Knee System is showing a favorable gap balancing technique and the possibility to create individualized alignment.
The ROSA® robotic system has been recently introduced in the market and presents specific and peculiar features to optimize ligament balancing and an individualized alignment of the implant in a three dimensional prospective.
Imageless robotic-assisted total knee arthroplasty is accurate in vivo: a retrospective study to measure the postoperative bone resection and alignment
Schrednitzki D, Horn CE, Lampe UA, Halder AM. Arch Orthop Trauma Surg. 2022 Oct 21. doi: 10.1007/s00402-022-04648-2. Epub ahead of print. PMID: 36269397.
Key Takeaway: The imageless mode of ROSA Knee is accurate in vivo.
The use of the ROSA Knee imageless pathway is accurate in terms of coronal alignment and bone resections. This is consistent with published studies. The present paper is the first to show that the accuracy previously reported only in cadavers can also be achieved in patients.
Image-Free Robotic-Assisted Total Knee Arthroplasty Results in Quicker Recovery but Equivalent One-Year Outcomes Compared to Conventional Total Knee Arthroplasty.
Khan IA, Vaile JR, DeSimone CA, Parsell DE, Heinze JD, Alessi A, Xu W, Shah RP, Pickering T, Cafferky NL, Lonner JH. J Arthroplasty. 2023 Feb 18:S0883-5403(23)00131-6. doi: 10.1016/j.arth.2023.02.023. Epub ahead of print. PMID: 36801477.
Key Takeaway: ROSA® Knee has resulted in a faster recovery following total knee arthroplasty in regards to KOOS JR scores.
Image-free RA-TKA reduces pain and improves early functional recovery compared to C-TKA at 4 to 6 weeks, but functional outcomes at 1 year are equivalent based on the MCID and PASS for KOOS-JR.
Earlier Gains in Active Range of Motion Following Robotic-Assisted Total Knee Arthroplasty Compared with Conventional Instrumentation.
Fary, C. Tripuraneni K, Klar B, Ren AN, Abshagen S, Verheul R. Orthopaedic Proceedings. 2023;105-B(SUPP_2):43-43. doi:doi:10.1302/1358-992X.2023.2.043.
Key Takeaway: ROSA® Knee has resulted in a faster recovery following total knee arthroplasty in regards to range-of-motion.
raTKA resulted in greater AROM flexion gains in the early postoperative period than cTKA. Additional research is needed to understand if these earlier gains in AROM are associated with improved patient satisfaction and continued improvements with time.
A new robotically assisted technique can improve outcomes of total knee arthroplasty comparing to an imageless navigation system
Mancino F, Rossi SMP, Sangaletti R, Lucenti L, Terragnoli F, Benazzo F. Arch Orthop Trauma Surg. 2022
Key Takeaway
: Imageless robotic TKA demonstrates improved ROM and
less pain at 12 months following TKA compared to imageless navigation.
Introduction of ROSA robotic-arm system for total knee arthroplasty is associated with a minimal learning curve for operative time
Bolam SM, Tay ML, Zaidi F, et al. Journal of Experimental Orthopaedics. 2022;9(1):86.
Key Takeaway
: The most pertinent finding of this study was that
there was a learning curve of between 5 and 15 cases associated with
the introduction of this RA TKA system. There was no significant
increase in operative time in the RA TKA group compared to the
conventional TKA group. There were no post-operative complications
associated with the introduction of this system.
An anatomo-functional implant positioning technique with robotic assistance for primary TKA allows the restoration of the native knee alignment and a natural functional ligament pattern, with a faster recovery at 6 months compared to an adjusted mechanical technique.
Parratte S, Van Overschelde P, Bandi M, Ozturk BY, Batailler C. Knee Surg Sports Traumatol Arthrosc. 2022.
Key Takeaway
: Faster recovery using an anatomo-functional implant
positioning (AFIP) technique for robotic total knee arthroplasty
compared to an adjusted mechanical alignment (aMA) technique.
“The AFIP concept allowed the restoration of the native knee anatomy and alignment with a natural ligament pattern.
With a more physiological target for ligament balancing, robotically-assisted AFIP technique had equivalent clinical outcomes at 12 months compared to aMA, with a faster recovery”
Comparative outcomes between a new robotically assisted and a manual technique for total knee arthroplasty in patients with osteoarthritis: a prospective matched comparative cohort study.
Kenanidis E, Paparoidamis G, Milonakis N, Potoupnis M, Tsiridis E. European Journal of Orthopaedic Surgery & Traumatology. 2022.
Key Takeaway: raTKA was associated with the same complication risk, less pain level, better patient satisfaction, and PROMs on 6-month follow-up than the mTKA group.
“One of the first comparative clinical studies evaluating outcome differences between ROSA raTKA and mTKA”, and the “results indicate that raTKA may help enhance the early functional recovery of TKA patients and promote a better satisfaction level in the early postoperative period.”
Total Knee Arthroplasty With Robotic Surgical Assistance Results in Less Physician Stress and Strain Than Conventional Methods
Haffar A, Krueger CA, Goh GS, Lonner JH. 2022 Jun;37(6S):S193-S200.
Key Takeaway: Robotic assistance may help to increase surgical efficiency and reduce physician workload
Total energy expenditure was lower in robotic TKA than conventional TKA. Average heart rate was lower in robotic TKA. Robotic TKA resulted in less lumbar flexion and a reduction in the time spent in demanding lumbar flexion. Neck rotation was significantly reduced by robotic TKA.
Is sequential bilateral robotic total knee arthroplasty a safe procedure? A matched comparative pilot study.
Batailler C, Anderson MB*, Flecher X, Ollivier M, Parratte S. Archives of Orthopaedic and Trauma Surgery 2022.
Key Takeaway: Sequential bilateral TKA performed with robotic assistance more accurately restores knee alignment with similar perioperative outcomes and better Knee Society functional scores at six months postoperative compared to conventional instrumentation, despite a longer surgical time.
Bilateral sequential TKA is a valid option for improving accuracy and early outcomes, without posing an additional risk of complications.
A Personal Journey through, and review of, the Landscape of Surgical Robotics in Knee Arthroplasty: My Transition from Mako® to NAVIO™ and finally to the ROSA® Knee System†
Lonner H. Jess, Journal of Orthopaedic Experience & Innovation 2022.
Key Takeaway: The potential of the confluence of the ROSA Knee System and analytics platforms to simplify the surgical procedure, improve accuracy, and provide a vehicle for mass customization and individualization of care for each patient is a noteworthy advance.
Dr. Lonner concludes that the value of contemporary knee robotics may not yet be fully appreciated, which is emphasized by the prospects of advancing AI with pre, intra, and post-operative data in order to further optimize outcomes for TKA. He feels that robotics in arthroplasty is on the verge of becoming “self-evident”.
The initial learning curve for the ROSA® Knee System can be achieved in 6-11 cases for operative time and has similar 90-day complication rates with improved implant alignment compared to manual instrumentation in total knee arthroplasty.
Vanlommel, Luc, Enrico Neven, Mike B. Anderson*, Liesbeth Bruckers, Jan Truijen. Journal of Experimental Orthopaedics (2021) 8:119
Key Takeaway: The data demonstrated a relatively rapid learning curve for operative times associated with adoption of this novel robotic system.
As the digital age of medicine continues to develop, advanced technologies may disrupt the industry, but should not disrupt the care provided. This cutting guide positioning robotic system can be integrated relatively quickly with a rapid initial learning curve (6-11 cases) for operative times, similar 90-day complication rates, and improved component positioning compared to mTKA. Proficiency of the system requires additional analysis, but it can be expected to improve over time.
Using Standard X-ray Images to Create 3D Digital Bone Models and Patient-Matched Guides for Aiding Implant Positioning and Sizing in Total Knee Arthroplasty†
Massé, Vincent and Raju S. Ghate. Computer Assisted Surgery, 26:1, 31-40, published online 15 Mar 2021
Key Takeaway: X-Atlas™ imaging technology could effectively predict implant sizing.
The X-Atlas™ imaging technology proved to be accurate to reconstruct a 3D bone model and results have shown that it might provide benefits to surgeons seeking improved planning and precision without the problems of obtaining 3D imaging.
Registration of Bony Landmarks and Soft Tissue Laxity During Robotic Total Knee Arthroplasty is Highly Reproducible.
Charette, R., Sarpong, N., Weiner, T., Shah, R., Cooper, J. Surg Technol Int. 2022
Key Takeaway: High reproducibility of bony landmarks and tissue laxity among robotic TKA experienced and novice surgeons.
Excellent intra-rater reliability for both rTKA experienced (ICC = 0.952) and inexperienced (ICC = 0.925) surgeons. Excellent inter-rater reliability between rTKA experienced and inexperienced surgeons for both imageless and image-based. Excellent reliabilities for soft tissue laxities suggest that inherent differences in tension applied by physicians during the dynamic stress evaluation will not affect the ROSA Knee System gap analysis.[The] results show a high repeatability of registration of anatomic landmarks and gap assessment among observers using this robotic system for both image-based and [imageless] software.
High accuracy of a new robotically assisted technique for total knee arthroplasty: an in vivo study.
Rossi SMP, Sangaletti R, Perticarini L, Terragnoli F, Benazzo F. Knee Surg Sports Traumatol Arthrosc 2022
Key Takeaway: The ROSA Knee system demonstrated a high degree of in vivo accuracy.
The average difference between planned and validated measures were below 1 mm or under 1 degree with SD < 1.
The average difference between planned HKA and measured was 1.2 ± 1.1 degrees.
“…using this new surgical robot in total knee arthroplasty [makes it] possible to perform accurate bone cuts and to achieve the planned angles and resections.”
동영상
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ROSA Introductory BioSkills Event
Up Next: May 15, 2022
One full day cadaveric experience in preparation for live cases. Event will consist of didactive presentations, sawbone based demonstrations, and a cadaveric specimen for each participating surgeon.
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유한회사 짐머바이오메트코리아
서울특별시 용산구 한남동
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Disclaimer
본 사이트의 모든 콘텐츠는 달리 명시하지 않는 한 Zimmer Biomet 또는 그 계열사가 소유하거나 라이선스를 부여받은 저작권, 상표 및 기타 지적 재산권에 의해 보호되며, Zimmer Biomet의 서면 동의 없이 전체 또는 일부를 재배포, 복제 또는 공개할 수 없음을 명시합니다.
본 자료들은 의료 전문가를 위한 페이지이므로 다른 이에게 배포하는 것은 금지되어 있습니다.
적응증, 금기 사항, 경고, 주의 사항, 잠재적 부작용 및 환자 상담 정보를 포함한 제품 정보는 제품의 패키지를 직접 참조하십시오
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- Internal Persona Knee Cumulative Sales Report – Sales Globally as of May 2019.
- Statement based on: 5 million implantations7h 300+ Publications7g 100% Survivorship at 17 Years Lowest revision rate7b-e Benchmark for PROMs7f 10A* ODEP rating for CR and PS knees both with and without patella7g Every 90 seconds a patient receives a NexGen knee7h 1 in 5 knees implanted globally is a NexGen Knee7i 7a. Kim, Y.H., et al. Cementless and cemented total knee arthroplasty in patients younger than fifty five years. Which is better? International Orthopaedics (SICOT) (2014) 38:297–303. 7b. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide.AOA 2016: Table KT9 Cumulative Percent Revision of Primary Total Knee Replacement with Cement Fixation. 7c. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide.AOA 2016: Table KT10 Cumulative Percent Revision of Primary Total Knee Replacement with Cementless Fixation. 7d. Australian Orthopaedic Association National Joint Replacement Registry. Annual Report. Adelaide. AOA 2016: Table KT11 Cumulative Percent Revision of Primary Total Knee Replacement with Hybrid Fixation. 7e. Select variants from the 2016 Swedish National Registry available at http://myknee.se/en/ (pgs 42-43). 7f. Baker, P.N., et al. The effect of surgical factors on early patient-reported outcome measures (PROMs) following total knee replacement. J Bone Joint Surg Br. 94:1058, 2012. 7g. Latest ODEP ratings can be found at http://www.odep. org.uk. 7h. 2015 Sales data available at Zimmer Biomet. 7i. EMBASE search: «NexGen» AND «Knee».
- Seidenstein A, Birmingham M, Foran J, Ogden S. Better accuracy and reproducibility of a new robotically-assisted system for total knee arthroplasty compared to conventional instrumentation: a cadaveric study. Knee Surg Sports Traumatol Arthrosc. 2020 May 24. doi: 1007/s00167-020- 06038-w. Epub ahead of print. PMID: 32448945. Cadaveric testing is not necessarily indicative of clinical performance
- Parratte, S., et al. Instability After Total Knee
Arthroplasty. Journal of Bone Joint Surgery (America). 90(1): 184,
2008. Cadaveric testing is not necessarily indicative of clinical
performance.