A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty_Chinese Journal of Reparative and Reconstructive Surgery

Authors：

LI Yicheng ¹ ,  ZHANG Xiaogang ¹ ,  CAO Li ¹ , SUN Yongqiang ² , YE Ye ² , XIE Jie ³ , HU Yihe ³ , LI Zhong ⁴ , TANG Bensen ⁵

1. Department of Orthopedics, the First Affiliated Hospital of Xinjiang Medical University, Urumqi Xinjiang, 830054, P. R. China;
2. Department of Orthopedics, Luoyang Orthropedic-Traumatological Hospital of Henan Province (Henan Provincial Orthopedic Hospital), Zhengzhou Henan, 450016, P. R. China;
3. Department of Orthopedics, the First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou Zhejiang, 310006, P. R. China;
4. Department of Orthopedics, the Affiliated Hospital of Southwest Medical University, Luzhou Sichuan, 646099, P. R. China;
5. Department of Orthopedics, the Guizhou Provincial Orthopedic Hospital, Guiyang Guizhou, 550007, P. R. China;

Corresponding author：

ZHANG Xiaogang, Email: zxgjohn1972@sina.com; CAO Li, Email: xjbone@sina.com

Keywords：

Knee osteoarthritis; total knee arthroplasty; robot-assisted surgery; multicenter study

DOI：

10.7507/1002-1892.202307078

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Objective To investigate the accuracy, safety, and short-term effectiveness of a domestic robot-assisted system in total knee arthroplasty (TKA) by a multicenter randomized controlled trial. Methods Between December 2021 and February 2023, 138 patients with knee osteoarthritis who received TKA in 5 clinical centers were prospectively collected, and 134 patients met the inclusion criteria were randomly assigned to either a trial group (n=68) or a control group (n=66). Seven patients had lost follow-up and missing data, so they were excluded and the remaining 127 patients were included for analysis, including 66 patients in the trial group and 61 patients in the control group. There was no significant difference (P>0.05) in gender, age, body mass index, side, duration of osteoarthritis, Kellgren-Lawrence grading, preoperative Knee Society Score (KSS) and Western Ontario and McMaster University Osteoarthritis Index (WOMAC) score between the two groups. The trial group completed the TKA by domestic robot-assisted osteotomy according to the preoperative CT-based surgical planning. The control group was performed by traditional osteotomy plate combined with soft tissue release. Total operation time, osteotomy time of femoral/tibial side, intraoperative blood loss, and postoperative complications were recorded and compared between the two groups. The radiographs were taken at 5 and 90 days after operation, and hip-knee-ankle angle (HKA), lateral distal angle of femur (LDFA), and posterior tibial slope (PTS) were measured. The difference between the measured values of the above indexes at two time points after operation and the preoperative planning target values was calculated, and the absolute value (absolute error) was taken for comparison between the two groups. The postoperative recovery of lower limb alignment was judged and the accuracy was calculated. KSS score and WOMAC score were used to evaluate the knee joint function of patients before operation and at 90 days after operation. The improvement rates of KSS score and WOMAC score were calculated. The function, stability, and convenience of the robot-assisted system were evaluated by the surgeons. Results The total operation time and femoral osteotomy time of the trial group were significantly longer than those of the control group (P<0.05). There was no significant difference in the tibial osteotomy time and the amount of intraoperative blood loss between the two groups (P>0.05). The incisions of both groups healed by first intention after operation, and there was no infection around the prosthesis. Nine patients in the trial group and 8 in the control group developed lower extremity vascular thrombosis, all of which were calf intermuscular venous thrombosis, and there was no significant difference in the incidence of complications (P>0.05). All patients were followed up 90 days. There was no significant difference in KSS score and WOMAC score between the two groups at 90 days after operation (P>0.05). There was significant difference in the improvement rate of KSS score between the two groups (P<0.05), while there was no significant difference in the improvement rate of WOMAC score between the two groups (P>0.05). Radiological results showed that the absolute errors of HKA and LDFA in the trial group were significantly smaller than those in the control group at 5 and 90 days after operation (P<0.05), and the recovery accuracy of lower limb alignment was significantly higher than that in control group (P<0.05). The absolute error of PTS in the trial group was significantly smaller than that in the control group at 5 days after operation (P<0.05), but there was no significant difference at 90 days between the two groups (P>0.05). The functional satisfaction rate of the robot-assisted system was 98.5% (65/66), and the satisfaction rates of stability and convenience were 100% (66/66). Conclusion Domestic robot-assisted TKA is a safe and effective surgical treatment for knee osteoarthritis, which can achieve favorable lower limb alignment reconstruction, precise implant of prosthesis, and satisfactory functional recovery.

Citation： LI Yicheng, ZHANG Xiaogang, CAO Li, SUN Yongqiang, YE Ye, XIE Jie, HU Yihe, LI Zhong, TANG Bensen. A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty. Chinese Journal of Reparative and Reconstructive Surgery, 2023, 37(11): 1326-1334. doi: 10.7507/1002-1892.202307078 Copy

1.	Rezuş E, Burlui A, Cardoneanu A, et al. From pathogenesis to therapy in knee osteoarthritis: bench-to-bedside. Int J Mol Sci, 2021, 22(5): 2697.
2.	梅轶芳, 张志毅. 中国骨关节炎流行病学调查研究: 任重而道远. 中华风湿病学杂志, 2019, 23(2): 73-75.
3.	Long H, Zeng X, Liu Q, et al. Burden of osteoarthritis in China, 1990-2017: findings from the Global Burden of Disease Study 2017. The Lancet Rheumatology, 2020, 2(3): e164-e172.
4.	Choi YJ, Ra HJ. Patient satisfaction after total knee arthroplasty. Knee Surg Relat Res, 2016, 28(1): 1-15.
5.	St Mart JP, Goh EL. The current state of robotics in total knee arthroplasty. EFORT Open Rev, 2021, 6(4): 270-279.
6.	Held MB, Grosso MJ, Gazgalis A, et al. Improved compartment balancing using a robot-assisted total knee arthroplasty. Arthroplast Today, 2021, 7: 130-134.
7.	Sherman WF, Wu VJ. Robotic Surgery in total joint arthroplasty: a survey of the AAHKS membership to understand the utilization, motivations, and perceptions of total joint surgeons. J Arthroplasty, 2020, 35(12): 3474-3481.
8.	Wang JC, Piple AS, Hill WJ, et al. Computer-navigated and robotic-assisted total knee arthroplasty: increasing in popularity without increasing complications. J Arthroplasty, 2022, 37(12): 2358-2364.
9.	夏润之, 童志成, 张经纬, 等. 国产 “鸿鹄” 膝关节置换手术机器人的早期临床研究. 实用骨科杂志, 2021, 27(2): 108-113, 117.
10.	乔桦, 何锐, 张经纬, 等. 机器人辅助全膝关节置换术的多中心临床研究. 中华骨科杂志, 2023, 43(1): 23-30.
11.	Xia R, Zhai Z, Zhang J, et al. Verification and clinical translation of a newly designed “Skywalker” robot for total knee arthroplasty: A prospective clinical study. J Orthop Translat, 2021, 29: 143-151.
12.	Cherian JJ, Kapadia BH, Banerjee S, et al. Mechanical, anatomical, and kinematic axis in TKA: Concepts and practical applications. Curr Rev Musculoskelet Med, 2014, 7(2): 89-95.
13.	Zapata G, Sanz-Pena I, Verstraete M, et al. Effects of femoral component placement on the balancing of a total knee at surgery. J Biomech, 2019, 86: 117-124.
14.	MacDessi SJ, Griffiths-Jones W, Harris IA, et al. Coronal plane alignment of the knee (CPAK) classification. Bone Joint J, 2021, 103-B(2): 329-337.
15.	Begum FA, Kayani B, Magan AA, et al. Current concepts in total knee arthroplasty: mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open, 2021, 2(6): 397-404.
16.	Chang JS, Kayani B, Wallace C, et al. Functional alignment achieves soft-tissue balance in total knee arthroplasty as measured with quantitative sensor-guided technology. Bone Joint J, 2021, 103-B(3): 507-514.
17.	Clark G, Steer R, Wood D. Functional alignment achieves a more balanced total knee arthroplasty than either mechanical alignment or kinematic alignment prior to soft tissue releases. Knee Surg Sports Traumatol Arthrosc, 2023, 31(4): 1420-1426.
18.	Kayani B, Konan S, Tahmassebi J, et al. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials, 2020, 21(1): 194.
19.	Kim KI, Kim DK, Juh HS, et al. Robot-assisted total knee arthroplasty in haemophilic arthropathy. Haemophilia, 2016, 22(3): 446-452.
20.	Rivière C, Iranpour F, Auvinet E, et al. Alignment options for total knee arthroplasty: A systematic review. Orthop Traumatol Surg Res, 2017, 103(7): 1047-1056.
21.	Song EK, Seon JK, Yim JH, et al. Robotic-assisted TKA reduces postoperative alignment outliers and improves gap balance compared to conventional TKA. Clin Orthop Relat Res, 2013, 471(1): 118-126.
22.	Zhang J, Ndou WS, Ng N, et al. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc, 2022, 30(8): 2677-2695.
23.	Hampp EL, Sodhi N, Scholl L, et al. Less iatrogenic soft-tissue damage utilizing robotic-assisted total knee arthroplasty when compared with a manual approach: A blinded assessment. Bone Joint Res, 2019, 8(10): 495-501.
24.	Khlopas A, Sodhi N, Hozack WJ, et al. Patient-reported functional and satisfaction outcomes after robotic-arm-assisted total knee arthroplasty: early results of a prospective multicenter investigation. J Knee Surg, 2020, 33(7): 685-690.
25.	Bhimani SJ, Bhimani R, Smith A, et al. Robotic-assisted total knee arthroplasty demonstrates decreased postoperative pain and opioid usage compared to conventional total knee arthroplasty. Bone Jt Open, 2020, 1(2): 8-12.
26.	Li Z, Chen X, Wang X, et al. HURWA robotic-assisted total knee arthroplasty improves component positioning and alignment—A prospective randomized and multicenter study. J Orthop Translat, 2022, 33: 31-40.
27.	Jeon SW, Kim KI, Song SJ. Robot-assisted total knee arthroplasty does not improve long-term clinical and radiologic outcomes. J Arthroplasty, 2019, 34(8): 1656-1661.
28.	Vermue H, Luyckx T, Winnock de Grave P, et al. Robot-assisted total knee arthroplasty is associated with a learning curve for surgical time but not for component alignment, limb alignment and gap balancing. Knee Surg Sports Traumatol Arthrosc, 2022, 30(2): 593-602.

1. Rezuş E, Burlui A, Cardoneanu A, et al. From pathogenesis to therapy in knee osteoarthritis: bench-to-bedside. Int J Mol Sci, 2021, 22(5): 2697.
2. 梅轶芳, 张志毅. 中国骨关节炎流行病学调查研究: 任重而道远. 中华风湿病学杂志, 2019, 23(2): 73-75.
3. Long H, Zeng X, Liu Q, et al. Burden of osteoarthritis in China, 1990-2017: findings from the Global Burden of Disease Study 2017. The Lancet Rheumatology, 2020, 2(3): e164-e172.
4. Choi YJ, Ra HJ. Patient satisfaction after total knee arthroplasty. Knee Surg Relat Res, 2016, 28(1): 1-15.
5. St Mart JP, Goh EL. The current state of robotics in total knee arthroplasty. EFORT Open Rev, 2021, 6(4): 270-279.
6. Held MB, Grosso MJ, Gazgalis A, et al. Improved compartment balancing using a robot-assisted total knee arthroplasty. Arthroplast Today, 2021, 7: 130-134.
7. Sherman WF, Wu VJ. Robotic Surgery in total joint arthroplasty: a survey of the AAHKS membership to understand the utilization, motivations, and perceptions of total joint surgeons. J Arthroplasty, 2020, 35(12): 3474-3481.
8. Wang JC, Piple AS, Hill WJ, et al. Computer-navigated and robotic-assisted total knee arthroplasty: increasing in popularity without increasing complications. J Arthroplasty, 2022, 37(12): 2358-2364.
9. 夏润之, 童志成, 张经纬, 等. 国产 “鸿鹄” 膝关节置换手术机器人的早期临床研究. 实用骨科杂志, 2021, 27(2): 108-113, 117.
10. 乔桦, 何锐, 张经纬, 等. 机器人辅助全膝关节置换术的多中心临床研究. 中华骨科杂志, 2023, 43(1): 23-30.
11. Xia R, Zhai Z, Zhang J, et al. Verification and clinical translation of a newly designed “Skywalker” robot for total knee arthroplasty: A prospective clinical study. J Orthop Translat, 2021, 29: 143-151.
12. Cherian JJ, Kapadia BH, Banerjee S, et al. Mechanical, anatomical, and kinematic axis in TKA: Concepts and practical applications. Curr Rev Musculoskelet Med, 2014, 7(2): 89-95.
13. Zapata G, Sanz-Pena I, Verstraete M, et al. Effects of femoral component placement on the balancing of a total knee at surgery. J Biomech, 2019, 86: 117-124.
14. MacDessi SJ, Griffiths-Jones W, Harris IA, et al. Coronal plane alignment of the knee (CPAK) classification. Bone Joint J, 2021, 103-B(2): 329-337.
15. Begum FA, Kayani B, Magan AA, et al. Current concepts in total knee arthroplasty: mechanical, kinematic, anatomical, and functional alignment. Bone Jt Open, 2021, 2(6): 397-404.
16. Chang JS, Kayani B, Wallace C, et al. Functional alignment achieves soft-tissue balance in total knee arthroplasty as measured with quantitative sensor-guided technology. Bone Joint J, 2021, 103-B(3): 507-514.
17. Clark G, Steer R, Wood D. Functional alignment achieves a more balanced total knee arthroplasty than either mechanical alignment or kinematic alignment prior to soft tissue releases. Knee Surg Sports Traumatol Arthrosc, 2023, 31(4): 1420-1426.
18. Kayani B, Konan S, Tahmassebi J, et al. A prospective double-blinded randomised control trial comparing robotic arm-assisted functionally aligned total knee arthroplasty versus robotic arm-assisted mechanically aligned total knee arthroplasty. Trials, 2020, 21(1): 194.
19. Kim KI, Kim DK, Juh HS, et al. Robot-assisted total knee arthroplasty in haemophilic arthropathy. Haemophilia, 2016, 22(3): 446-452.
20. Rivière C, Iranpour F, Auvinet E, et al. Alignment options for total knee arthroplasty: A systematic review. Orthop Traumatol Surg Res, 2017, 103(7): 1047-1056.
21. Song EK, Seon JK, Yim JH, et al. Robotic-assisted TKA reduces postoperative alignment outliers and improves gap balance compared to conventional TKA. Clin Orthop Relat Res, 2013, 471(1): 118-126.
22. Zhang J, Ndou WS, Ng N, et al. Robotic-arm assisted total knee arthroplasty is associated with improved accuracy and patient reported outcomes: a systematic review and meta-analysis. Knee Surg Sports Traumatol Arthrosc, 2022, 30(8): 2677-2695.
23. Hampp EL, Sodhi N, Scholl L, et al. Less iatrogenic soft-tissue damage utilizing robotic-assisted total knee arthroplasty when compared with a manual approach: A blinded assessment. Bone Joint Res, 2019, 8(10): 495-501.
24. Khlopas A, Sodhi N, Hozack WJ, et al. Patient-reported functional and satisfaction outcomes after robotic-arm-assisted total knee arthroplasty: early results of a prospective multicenter investigation. J Knee Surg, 2020, 33(7): 685-690.
25. Bhimani SJ, Bhimani R, Smith A, et al. Robotic-assisted total knee arthroplasty demonstrates decreased postoperative pain and opioid usage compared to conventional total knee arthroplasty. Bone Jt Open, 2020, 1(2): 8-12.
26. Li Z, Chen X, Wang X, et al. HURWA robotic-assisted total knee arthroplasty improves component positioning and alignment—A prospective randomized and multicenter study. J Orthop Translat, 2022, 33: 31-40.
27. Jeon SW, Kim KI, Song SJ. Robot-assisted total knee arthroplasty does not improve long-term clinical and radiologic outcomes. J Arthroplasty, 2019, 34(8): 1656-1661.
28. Vermue H, Luyckx T, Winnock de Grave P, et al. Robot-assisted total knee arthroplasty is associated with a learning curve for surgical time but not for component alignment, limb alignment and gap balancing. Knee Surg Sports Traumatol Arthrosc, 2022, 30(2): 593-602.

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A multicenter randomized controlled trial of domestic robot-assisted and conventional total knee arthroplasty

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