Precise Acetabular Prosthesis Positioning Using a Novel Robot-Assisted Total Hip Arthroplasty System: A Multicenter, Randomized Controlled Trial

Abstract

Objective: Total hip arthroplasty (THA) is currently one of the most effective treatment methods for end-stage hip joint disease, and its long-term effectiveness largely depends on the accurate placement of the acetabular prosthesis. In conventional surgery, the placement of the acetabular prosthesis mainly relies on the surgeon’s clinical experience and surgical techniques. To further improve the accuracy of prosthesis placement, a new robotic system for THA is designed. The purpose of this study is to verify the effectiveness and safety of THA assisted by this robotic system.

Method: A multicenter, prospective, randomized controlled, superiority study design was adopted with statistical methods of t test and Chi-squared test. Participants undergoing primary THA have been enrolled in three centers of joint surgery in China since July 17, 2023. Robotic THA was operated in the experimental group, and conventional instruments were used in the control group. The primary outcome is the proportion of anteversion and inclination angles in the safe zone. The secondary outcomes include operation time, WOMAC score, Harris score, SF-36 health questionnaire, dislocation rate of hip joint, and rates of adverse events and serious adverse events.

Results: A total of 138 patients were included in this study. The proportion of both anteversion and inclination angles in the safe zone was 92.2% in the experimental group and 50.8% in the control group, with significant difference (p < 0.01). The average operation time in the experimental group and control group was 116.4 and 80.5 min respectively, with significant difference (p < 0.01). There was no significant difference in WOMAC score, Harris score, and SF-36 between the two groups (6 ± 2) weeks after operation (p > 0.05). The dislocation rate of hip joint in the experimental group and control group were 3.0% and 1.5%, respectively, without significant difference (p > 0.05). The rate of adverse events and severe adverse events in the experimental group and control group also showed no significant difference (p > 0.05). No adverse events or serious adverse events were judged to be “definitely related” to the experimental instruments.

Conclusion: Robotic THA could prolong the operation time within an acceptable range, but more precise acetabular prosthesis positioning could be obtained when compared with conventional surgery. Besides, no significant difference was found in function scores, dislocation rate or other adverse events, which indicates that this new robot system shows both good effectiveness and safety in THA.

Trial Registration: Clinical Trials: NCT05947734

Keywords

acetabular prosthesis positioning / anteversion angle / inclination angle / robotic surgery / total hip arthroplasty

References

[1] W. Konarski, T. Poboży, A. Śliwczyński, et al., “Avascular Necrosis of Femoral Head—Overview and Current State of the Art,” International Journal of Environmental Research and Public Health 19 (2022): 7348,

[2] J. N. Katz, K. R. Arant, and R. F. Loeser, “Diagnosis and Treatment of Hip and Knee Osteoarthritis: A Review,” JAMA 325 (2021): 568–578,

[3] C. Changjun, L. Donghai, Z. Xin, C. Liyile, W. Qiuru, and K. Pengde, “Mid-To Long-Term Results of Modified Non-Vascularized Allogeneic Fibula Grafting Combined With Core Decompression and Bone Grafting for Early Femoral Head Necrosis,” Journal of Orthopaedic Surgery and Research 15 (2020): 116,

[4] B. Vander Cruyssen, N. Vastesaeger, and E. Collantes-Estévez, “Hip Disease in Ankylosing Spondylitis,” Current Opinion in Rheumatology 25 (2013): 448–454,

[5] R. J. Ferguson, A. J. Palmer, A. Taylor, M. L. Porter, H. Malchau, and S. Glyn-Jones, “Hip Replacement,” Lancet 392 (2018): 1662–1671,

[6] I. D. Learmonth, C. Young, and C. Rorabeck, “The Operation of the Century: Total Hip Replacement,” Lancet 370 (2007): 1508–1519,

[7] J. R. Danoff, J. T. Bobman, G. Cunn, et al., “Redefining the Acetabular Component Safe Zone for Posterior Approach Total Hip Arthroplasty,” Journal of Arthroplasty 31 (2016): 506–511,

[8] G. E. Lewinnek, J. L. Lewis, R. Tarr, C. L. Compere, and J. R. Zimmerman, “Dislocations After Total Hip-Replacement Arthroplasties,” Journal of Bone and Joint Surgery. American Volume 60 (1978): 217–220.

[9] X. Chen, J. Xiong, P. Wang, et al., “Robotic-Assisted Compared With Conventional Total Hip Arthroplasty: Systematic Review and Meta-Analysis,” Postgraduate Medical Journal 94 (2018): 335–341,

[10] V. Kumar, S. Patel, V. Baburaj, R. K. Rajnish, and S. Aggarwal, “Does Robotic-Assisted Surgery Improve Outcomes of Total Hip Arthroplasty Compared to Manual Technique? A Systematic Review and Meta-Analysis,” Postgraduate Medical Journal 99 (2021): 375–383,

[11] K. F. Schulz, D. G. Altman, D. Moher, and CONSORT Group, “CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials,” BMC Medicine (2010): 18,

[12] T. Scheerlinck, “Cup Positioning in Total Hip Arthroplasty,” Acta Orthopaedica Belgica 80 (2014): 336–347.

[13] N. Bellamy, W. W. Buchanan, C. H. Goldsmith, J. Campbell, and L. W. Stitt, “Validation Study of WOMAC: A Health Status Instrument for Measuring Clinically Important Patient Relevant Outcomes to Antirheumatic Drug Therapy in Patients With Osteoarthritis of the Hip or Knee,” Journal of Rheumatology 15 (1988): 1833–1840.

[14] W. H. Harris, “Traumatic Arthritis of the Hip After Dislocation and Acetabular Fractures: Treatment by Mold Arthroplasty. An End-Result Study Using a New Method of Result Evaluation,” Journal of Bone and Joint Surgery. American Volume 51 (1969): 737–755.

[15] J. E. Brazier, R. Harper, N. M. Jones, et al., “Validating the SF-36 Health Survey Questionnaire: New Outcome Measure for Primary Care,” British Medical Journal 164 (1992): 305,

[16] A. Combes, H. Migaud, J. Girard, A. Duhamel, and M. H. Fessy, “Low Rate of Dislocation of Dual-Mobility Cups in Primary Total Hip Arthroplasty,” Clinical Orthopaedics and Related Research 471 (2013): 3891–3900,

[17] D. Piacentino, A. Ogirala, R. Lew, et al., “A Novel Method for Deriving Adverse Event Prevalence in Randomized Controlled Trials: Potential for Improved Understanding of Benefit-Risk Ratio and Application to Drug Labels,” Advances in Therapy 41 (2024): 152–169,

[18] B. G. Domb, Y. F. El Bitar, A. Y. Sadik, C. E. Stake, and I. B. Botser, “Comparison of Robotic-Assisted and Conventional Acetabular Cup Placement in THA: A Matched-Pair Controlled Study,” Clinical Orthopaedics and Related Research 472 (2014): 329–336,

[19] X. Kong, M. Yang, S. Jerabek, G. Zhang, J. Chen, and W. Chai, “A Retrospective Study Comparing a Single Surgeon’s Experience on Manual Versus Robot-Assisted Total Hip Arthroplasty After the Learning Curve of the Latter Procedure – A Cohort Study,” International Journal of Surgery 77 (2020): 174–180,

[20] T.-Y. Tsai, D. Dimitriou, J.-S. Li, and Y.-M. Kwon, “Does Haptic Robot-Assisted Total Hip Arthroplasty Better Restore Native Acetabular and Femoral Anatomy?,” International Journal of Medical Robotics and Computer Assisted Surgery 12 (2016): 288–295,

[21] B. G. Domb, J. M. Redmond, S. S. Louis, et al., “Accuracy of Component Positioning in 1980 Total Hip Arthroplasties: A Comparative Analysis by Surgical Technique and Mode of Guidance,” Journal of Arthroplasty 30 (2015): 2208–2218,

[22] R. K. Elmallah, J. J. Cherian, J. J. Jauregui, D. A. Padden, S. F. Harwin, and M. A. Mont, “Robotic-Arm Assisted Surgery in Total Hip Arthroplasty,” Surgical Technology International 26 (2015): 283–288.

[23] R. L. Illgen, B. R. Bukowski, R. Abiola, et al., “Robotic-Assisted Total Hip Arthroplasty: Outcomes at Minimum Two-Year Follow-Up,” Surgical Technology International 30 (2017): 365–372.

[24] X. Wang and X. Ji, “Sample Size Estimation in Clinical Research: From Randomized Controlled Trials to Observational Studies,” Chest 158 (2020): S12–S20,

[25] K. N. Kunze, P. Bovonratwet, E. M. Polce, K. Paul, and P. K. Sculco, “Comparison of Surgical Time, Short-Term Adverse Events, and Implant Placement Accuracy Between Manual, Robotic-Assisted, and Computer-Navigated Total Hip Arthroplasty: A Network Meta-Analysis of Randomized Controlled Trials,” JAAOS Global Research & Reviews 6 (2022): e21.00200,

[26] N. Kort, P. Stirling, P. Pilot, and J. H. Müller, “Clinical and Surgical Outcomes of Robot-Assisted Versus Conventional Total Hip Arthroplasty: A Systematic Overview of Meta-Analyses,” EFORT Open Reviews 6 (2021): 1157–1165,

[27] C. J. Hadley, E. L. Grossman, M. A. Mont, H. S. Salem, F. Catani, and A. Marcovigi, “Robotic-Assisted Versus Manually Implanted Total Hip Arthroplasty: A Clinical and Radiographic Comparison,” Surgical Technology International 37 (2020): 371–376.

[28] L. T. Samuel, A. J. Acuña, B. Mahmood, A. K. Emara, and A. F. Kamath, “Comparing Early and Mid-Term Outcomes Between Robotic-Arm Assisted and Manual Total Hip Arthroplasty: A Systematic Review,” Journal of Robotic Surgery 16 (2022): 735–748,

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2024 The Author(s). Orthopaedic Surgery published by Tianjin Hospital and John Wiley & Sons Australia, Ltd.