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Improved accuracy of implant placement with an imageless handheld robotic system compared to conventional instrumentation in patients undergoing total knee arthroplasty: a prospective randomized controlled trial using CT-based assessment of radiological outcomes

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Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope

Abstract

Purpose

Image-free handheld robotic-assisted total knee arthroplasty (RATKA) has shown to achieve desired limb alignment compared to conventional jig-based instrumented total knee arthroplasty (CTKA). The aim of this prospective randomized controlled trial (RCT) was to evaluate the accuracy of a semi-autonomous imageless handheld RATKA compared to CTKA in order to achieve the perioperative planned target alignment of the knee postoperatively.

Methods

Fifty-two patients with knee osteoarthritis were randomized in 1:1 ratio to undergo unilateral CTKA or an imageless handheld RATKA. A full-length lower limb CT-scan was obtained pre- and 6-week postoperative. The primary outcomes were radiologic measurements of achieved target hip–knee–ankle axis (HKA-axis) and implant component position including varus and external rotation and flexion of the femur component, and posterior tibial slope. The proportion of outliers in above radiographic outcomes, defined as > 3° deviation in postoperative CT measurements as compared to perioperative planned target, were also noted. Knee phenotypes were compared with use of the Coronal Plane Alignment of the Knee (CPAK) classification.

Results

Baseline conditions were comparable between both groups. The overall proportion and percentage of outliers (n = 38, 24.4% vs n = 9, 5.8%) was statistically significant (p < 0.001) in favor of RATKA. The achieved varus–valgus of the femoral component (varus 1.3° ± 1.7° vs valgus − 0.1° ± 1.9°, p < 0.05) with statistically significant less outliers (0% vs 88.5%, p < 0.01), the achieved HKA-axis (varus 0.4° ± 2.1° vs valgus − 1.2° ± 2.1°, p < 0.05) and the posterior tibial slope (1.4° ± 1.1° vs 3.2° ± 1.8°, p < 0.05) were more accurate with RATKA. The most common postoperative CPAK categories were type II (50% CTKA vs 61.5% RATKA), type I (3.8% CTKA vs 23.1% RATKA) and type V (26.9% CTKA vs 15.4% RATKA). CPAK classification III was only found in CTKA (19.2%). Type VI, VII, VIII, and IX were rare in both populations.

Conclusions

The present trial demonstrates that an imageless handheld RATKA system can be used to accurately perioperatively plan the desired individual component implant positions with less alignment outliers whilst aiming for a constitutional alignment.

Level of evidence

I.

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Funding

This investigator-initiated RCT is funded by Smith & Nephew, Memphis, TN, USA.

Author information

Authors and Affiliations

  1. Department of Orthopedic Surgery, St. Trudo Hospital, Sint-Truiden, Belgium

    Peter Bollars, Daniel Janssen & Wim De Weerdt

  2. Department of Orthopedic Surgery, Mediclinic City Hospital, Dubai Healthcare City, Dubai, United Arab Emirates

    Ali Albelooshi & Prashant Meshram

  3. Orthocure Medical Center, Dubai, United Arab Emirates

    Ali Albelooshi & Prashant Meshram

  4. Department of Mechanical, Aerospace, and Biomedical Engineering, University of Tennessee, Knoxville, TN, USA

    Thang D. Nguyen & Michael T. Lacour

  5. Department of Orthopedic Surgery and Traumatology, Zuyderland Medical Center, Sittard-Geleen, The Netherlands

    Martijn G. M. Schotanus

  6. School of Care and Public Health Research Institute, Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands

    Martijn G. M. Schotanus

Authors
  1. Peter Bollars
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  2. Daniel Janssen
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  6. Thang D. Nguyen
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Contributions

PB: co-conceived and designed the study, gathered and analyzed all the data, wrote the initial draft of the manuscript and managed the study. DJ: co-conceived the study ensured the accuracy of the data and the analysis, wrote and revised the manuscript. WW: designed the study and revised the manuscript. AA: designed the study and revised the manuscript. PM: ensured the accuracy of the data and the analysis. ML: analyzed the data and revised the manuscript. TND: interpretation of data for the work and ensured the accuracy of the analysis. MS: co-conceived the study, analyzed the data, wrote and revised the manuscript. All authors read and approved the final version of the manuscript.

Corresponding author

Correspondence to Peter Bollars.

Ethics declarations

Conflict of interest

PB and AB are paid consultants for Smith & Nephew, outside of this work.

Ethical approval

The Ethics Committee Research UZ/KU Leuven in Belgium (Nr. S64149) gave written approval to carry out this trial.

Informed consent

All patients gave oral and written consent to be included in this trial.

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Bollars, P., Janssen, D., De Weerdt, W. et al. Improved accuracy of implant placement with an imageless handheld robotic system compared to conventional instrumentation in patients undergoing total knee arthroplasty: a prospective randomized controlled trial using CT-based assessment of radiological outcomes. Knee Surg Sports Traumatol Arthrosc 31, 5446–5452 (2023). https://doi.org/10.1007/s00167-023-07590-x

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