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Abstract

In this paper, with the goal of enhancing the minimally invasive spinal fixation procedure in osteoporotic patients, we propose a first-of-its-kind image-guided robotic framework for performing and autonomous and patient-specific procedure using a unique concentric tube steerable drilling robot (CT-SDR). Particularly, leveraging CT-SDR, we introduce the concept of J-shape drilling based on a pre-operative trajectory planned in CT scan of a patient followed by appropriate calibration, registration, and navigation steps to safely execute this trajectory in real-time using our unique robotic setup. To thoroughly evaluate the performance of our framework, we performed several experiments on two different vertebral phantoms designed based on CT scan of real patients.

Links to Paper and Supplementary Materials

Main Paper (Open Access Version): https://papers.miccai.org/miccai-2024/paper/3962_paper.pdf

SharedIt Link: pending

SpringerLink (DOI): pending

Supplementary Material: N/A

Link to the Code Repository

N/A

Link to the Dataset(s)

N/A

BibTex

@InProceedings{Sha_APatientSpecific_MICCAI2024,
        author = { Sharma, Susheela and Go, Sarah and Yakay, Zeynep and Kulkarni, Yash and Kapuria, Siddhartha and Amadio, Jordan P. and Rajebi, Reza and Khadem, Mohsen and Navab, Nassir and Alambeigi, Farshid},
        title = { { A Patient-Specific Framework for Autonomous Spinal Fixation via a Steerable Drilling Robot } },
        booktitle = {proceedings of Medical Image Computing and Computer Assisted Intervention -- MICCAI 2024},
        year = {2024},
        publisher = {Springer Nature Switzerland},
        volume = {LNCS 15006},
        month = {October},
        page = {pending}
}

Reviews

Review #1

  • Please describe the contribution of the paper

    This paper introduces an image-guided robotic framework for concentric tube steerable drilling robot (CT-SDR).

  • Please list the main strengths of the paper; you should write about a novel formulation, an original way to use data, demonstration of clinical feasibility, a novel application, a particularly strong evaluation, or anything else that is a strong aspect of this work. Please provide details, for instance, if a method is novel, explain what aspect is novel and why this is interesting.

    This paper introduces an image-guided robot. However, image-guided robot is the existed basic framework and is widely used in surgical operation. The robot includes manual preoperative planning by doctors, basic robot calibration and ICP registration method in intraoperative navigation. These methods are basic operates using in many robots and not interesting[1][2].

    [1] Shi C, Zhao X, Wu X, et al. Real-time 3D navigation-based semi-automatic surgical robotic system for pelvic fracture reduction[C]//2021 IEEE/RSJ International Conference on Intelligent Robots and Systems (IROS). IEEE, 2021: 9498-9503. [2] Woo S Y, Lee S J, Yoo J Y, et al. Autonomous bone reposition around anatomical landmark for robot-assisted orthognathic surgery[J]. Journal of Cranio-Maxillofacial Surgery, 2017, 45(12): 1980-1988.

  • Please list the main weaknesses of the paper. Please provide details, for instance, if you think a method is not novel, explain why and provide a reference to prior work.

    The proposed image-guided robotic framework is based on surgical planning, hand-eye calibration in preoperative stage, point cloud registration in the intraoperative navigation, and autonomous drilling of robotic. This drilling robot is not a novel robot and its key modules (such as surgical planning determining by the surgeon, navigation using ICP) do not present any outstanding method.

  • Please rate the clarity and organization of this paper

    Very Good

  • Please comment on the reproducibility of the paper. Please be aware that providing code and data is a plus, but not a requirement for acceptance.

    The submission does not mention open access to source code or data but provides a clear and detailed description of the algorithm to ensure reproducibility.

  • Do you have any additional comments regarding the paper’s reproducibility?

    N/A

  • Please provide detailed and constructive comments for the authors. Please also refer to our Reviewer’s guide on what makes a good review. Pay specific attention to the different assessment criteria for the different paper categories (MIC, CAI, Clinical Translation of Methodology, Health Equity): https://conferences.miccai.org/2024/en/REVIEWER-GUIDELINES.html

    The author needs to do more innovative work on key modules[3][4][5][6].

    1. Preoperative planning in this paper relies on manual annotation by doctors, and it is a basic and frequently-used method. The rapid development of deep learning provides new methods for intelligent surgical planning.
    2. In the intraoperative navigation section of this paper, the calibration and registration methods which are basic methods in exited multitudinous robots are not innovative. Collecting point cloud by hand using a calibrated digitizer tool during surgery is fundamental, difficult, and time-consuming. Since the collecting intraoperative point cloud is a part of the preoperative point cloud, and collecting point clouds usually contains noise points, the authors can focus on the method of collecting intraoperative point cloud and the method of improving the registration robustness.
    3. The control strategies which can ensure intraoperative safety and navigation accuracy are also important.

    [3] Xian Y, Zhang X, Luo X, et al. A semi-autonomous stereotactic brain biopsy robotic system with enhanced surgical safety and surgeon-robot collaboration[J]. IEEE Transactions on Biomedical Engineering, 2023. [4] Bian G B, Wei B T, Li Z, et al. Robotic Automatic Drilling for Craniotomy: Algorithms and In Vitro Animal Experiments[J]. IEEE/ASME Transactions on Mechatronics, 2023. [5] Hu J, Liu J, Guo Y, et al. A collaborative robotic platform for sensor-aware fibula osteotomies in mandibular reconstruction surgery[J]. Computers in Biology and Medicine, 2023, 162: 107040. [6] Zhang R, Wang J, Chen C. Automatic implant shape design for minimally invasive repair of pectus excavatum using deep learning and shape registration[J]. Computers in Biology and Medicine, 2023, 158: 106806.

  • Rate the paper on a scale of 1-6, 6 being the strongest (6-4: accept; 3-1: reject). Please use the entire range of the distribution. Spreading the score helps create a distribution for decision-making

    Strong Reject — must be rejected due to major flaws (1)

  • Please justify your recommendation. What were the major factors that led you to your overall score for this paper?

    This drilling robot is not a novel robot. Its key modules are basic operates using in many robots and not interesting.

  • Reviewer confidence

    Very confident (4)

  • [Post rebuttal] After reading the author’s rebuttal, state your overall opinion of the paper if it has been changed

    Reject — should be rejected, independent of rebuttal (2)

  • [Post rebuttal] Please justify your decision

    The authors claim that the novelty of the robot system is a flexible robotic system used in a drilling robot, autonomously determining the J-shaped trajectories. Admittedly a flexible robotic system for drilling is an interesting work, but the core of the system still relies on a doctor-determined J-curve, which is not novel. And the flexible instruments are strongly influenced by the subjects of surgery, and the model used for the experiments makes me worry about whether it could be used in the human body.



Review #2

  • Please describe the contribution of the paper

    The work addresses the limitations of other works such as change of surgical workflow and operation time by introducing nonlinear navigation and control techniques for a safer and more efficient drilling. The authors propose an image-guided robotic framework for performing an autonomous and patient-specific procedure for normal and osteoporotic patients using a unique concentric tube steerable drilling robot (CT-SDR). They introduce the concept of J-shape drilling based on a pre-operative trajectory planned in CT scan of a patient followed by appropriate calibration, registration, and navigation steps to safely execute this trajectory in real-time.

  • Please list the main strengths of the paper; you should write about a novel formulation, an original way to use data, demonstration of clinical feasibility, a novel application, a particularly strong evaluation, or anything else that is a strong aspect of this work. Please provide details, for instance, if a method is novel, explain what aspect is novel and why this is interesting.

    • The clinical problem was stated clearly and the literature were presented in a logical way introducing the research gaps. • The contribution of this paper is distinguishable from other works. • The method used was clearly shown and verified with clear experiments • The results were described in depth and explained

  • Please list the main weaknesses of the paper. Please provide details, for instance, if you think a method is not novel, explain why and provide a reference to prior work.

    • Figure 2, the transformations between the different frames could be more organized and the notations used could be less confusing to the reader. • The difference between a cadaver and the utilised phantom in the experiments should be mentioned along with the considerations during clinical testing on animals or human cadaver. • The operation time is compared to other literature but not the accuracy of placement.

  • Please rate the clarity and organization of this paper

    Very Good

  • Please comment on the reproducibility of the paper. Please be aware that providing code and data is a plus, but not a requirement for acceptance.

    The submission does not mention open access to source code or data but provides a clear and detailed description of the algorithm to ensure reproducibility.

  • Do you have any additional comments regarding the paper’s reproducibility?

    N/A

  • Please provide detailed and constructive comments for the authors. Please also refer to our Reviewer’s guide on what makes a good review. Pay specific attention to the different assessment criteria for the different paper categories (MIC, CAI, Clinical Translation of Methodology, Health Equity): https://conferences.miccai.org/2024/en/REVIEWER-GUIDELINES.html

    The paper is original and its contribution is significant for the application and it addresses some of the limitations of the current works but using an autonomous robot would brings challenges such as safety and acceptance by clinicians who do this type of procedure manually or through robotic assistance (not fully automated as proposed in this study). Moreover, eventhough realistic phantoms based on humans were used through CT scans, it is not clear how accurate they are from human dimensions’ and material properties and the tool-interaction with surrounding soft tissue. Additionally, it would be useful to include the translational perspective.

    Main comments:

    1. Figure 2, the transformations between the different frames could be more organised and the notations used could be less confusing to the reader.
    2. What would be the difference between a cadaver and the utilised phantom in the experiments? What would be the considerations during clinical testing on animals or humans?
    3. The operation time of the current setup is compared to other literature but not the accuracy of placement.

    Minor comments:

    1. Abstract 3rd line: “an autonomous” instead of “and autonomous”
    2. Introduction paragraph 4, line 4: “normal and osteoporotic patients”instead of “an”.
    3. Section “patient-specific autonomous robotic framework”, two lines before the last: add a comma “Next, the robot …”
    4. Section “patient-specific autonomous robotic framework”, the line before the last: “The following section describe” instead of “describes
    5. Section hardware calibration, pivot calibration 7th line: is represented by its rotation instead of “it’s”
    6. Results and disccsion section, line 17: “the” is written twice
    7. Section 3.2, capital letters are used inconsistently for the subsections. Make it consistent
    8. Figure 1 gives a good overview of the paper but needs more organisation and better selection of colors and arrows to be clearer
  • Rate the paper on a scale of 1-6, 6 being the strongest (6-4: accept; 3-1: reject). Please use the entire range of the distribution. Spreading the score helps create a distribution for decision-making

    Weak Accept — could be accepted, dependent on rebuttal (4)

  • Please justify your recommendation. What were the major factors that led you to your overall score for this paper?

    The contribution of the paper is significant and well presented. The investigation is deep enough to draw conclusions to the proposed technology with minor limitations that would not compromise the integrity of the paper. The ideas were presented clearly and to the point with very good figures and logical flow. The introduction was systematic and led smoothly to the gap in literature and the contribution of the paper. The methods used were innovative and simple at the same time and could be reproducible. Additionally, the experimental setup and conducted experiments were clearly described and helped in evaluating the proposed method. Some aspects need to be considered such as the deviation of the phantom from biological tissue. The robotics and kinematics details are not clearly presented in the current version of the manuscript.

  • Reviewer confidence

    Confident but not absolutely certain (3)

  • [Post rebuttal] After reading the author’s rebuttal, state your overall opinion of the paper if it has been changed

    N/A

  • [Post rebuttal] Please justify your decision

    N/A



Review #3

  • Please describe the contribution of the paper

    This paper describes the framework for a very complex system to assist spinal fixation: a combination of a concentric-tube steering drilling robot calibration, registration to the specific patient’s CT images and then a J-shaped drilling path. Tests are performed on a vertebral phantom and overall calibration errors of 4 mm are achieved and registration of 3 mm. Overall verification error was reported to be 3.5 mm p/m 0.64 mm.

  • Please list the main strengths of the paper; you should write about a novel formulation, an original way to use data, demonstration of clinical feasibility, a novel application, a particularly strong evaluation, or anything else that is a strong aspect of this work. Please provide details, for instance, if a method is novel, explain what aspect is novel and why this is interesting.

    Strengths: spinal fixation, especially for patients with osteoporosis, is very hard with both guidance and drilling challenges with a minimally invasive approach. This paper is ambitious in taking a full systems-level approach to all the critical steps that affect accuracy of the drill holes for the pedicle screw fixation. Each of the steps of plan -> calibrate -> register -> drill are all important in determining the overall accuracy of the final drill holes.

  • Please list the main weaknesses of the paper. Please provide details, for instance, if you think a method is not novel, explain why and provide a reference to prior work.

    Weaknesses: This is a narrow research niche: the methods are specific for pedicle screw insertion, the use of a particular steerable robot and the particular type of steerable drill (concentric tube). The errors (4 mm and 3 mm for calibration and registration and 3.5 mm overall verification error) seem borderline adequate for pedicle screw insertions. A review paper [A] on the accuracy of pedicle screw placement “It has been shown that medial pedicle perforation more than 4 mm may endanger the neural elements presenting neurological deficits. Although there is not strong evidence in the literature ensuring that pedicle violation less than 2 mm is safe, most surgeons consider it as safe zone of pedicle perforation.”, although it must be noted that a single number is not sufficient to determine success of screw placement. The point is that the errors need to be described in better context of the benefits of such guidance.

    [A] Gelalis ID, Paschos NK, Pakos EE, Politis AN, Arnaoutoglou CM, Karageorgos AC, Ploumis A, Xenakis TA. Accuracy of pedicle screw placement: a systematic review of prospective in vivo studies comparing free hand, fluoroscopy guidance and navigation techniques. Eur Spine J. 2012 Feb;21(2):247-55. doi: 10.1007/s00586-011-2011-3. Epub 2011 Sep 7. PMID: 21901328; PMCID: PMC3265579.

  • Please rate the clarity and organization of this paper

    Excellent

  • Please comment on the reproducibility of the paper. Please be aware that providing code and data is a plus, but not a requirement for acceptance.

    The submission does not provide sufficient information for reproducibility.

  • Do you have any additional comments regarding the paper’s reproducibility?

    The hardware of the image guided surgical robot is too complex for others to easily replicate.

  • Please provide detailed and constructive comments for the authors. Please also refer to our Reviewer’s guide on what makes a good review. Pay specific attention to the different assessment criteria for the different paper categories (MIC, CAI, Clinical Translation of Methodology, Health Equity): https://conferences.miccai.org/2024/en/REVIEWER-GUIDELINES.html

    The main contribution of this paper is the system integration of a series of complex steps for image guided spine surgery. The individual steps are not novel. The concentric tube steerable drilling robot has been reported earlier. The pivot calibration to determine the positioning of the end-effector refers to equation (1) and appears to be a straightforward minimization problem. The transformation between the optical tracker and the robot manipulator is done with class hand-eye calibration. The CT to patient registration is done with a conventional iterative closest point algorithm using digitized points on the surface of the vertebra. The optical tracker again used to verify the ground truth with digitized locations. An electromagnetic tracker was passed through the drill path to establish the drilling trajectory but, as the authors acknowledge, it isn’t clear whether the accuracy of the EM tracker is sufficient; the Aurora tracker has an accuracy according to its manufacturer as 0.5 mm with a 95% CI of 0.88 mm at best. It would be good to expand on the claim of 0.11 mm error in the created radius of curvature given the EM errors. Overall this paper still represents a tremendous amount of work tackling an important problem with a lot of information squeezed into the length of a MICCAI paper.

  • Rate the paper on a scale of 1-6, 6 being the strongest (6-4: accept; 3-1: reject). Please use the entire range of the distribution. Spreading the score helps create a distribution for decision-making

    Weak Accept — could be accepted, dependent on rebuttal (4)

  • Please justify your recommendation. What were the major factors that led you to your overall score for this paper?

    Although the novelty of the individual steps in the image-guided surgical robot are small, the overall effort and importance of a new system for guiding pedical screw insertions is high.

  • Reviewer confidence

    Very confident (4)

  • [Post rebuttal] After reading the author’s rebuttal, state your overall opinion of the paper if it has been changed

    Weak Accept — could be accepted, dependent on rebuttal (4)

  • [Post rebuttal] Please justify your decision

    The authors defended some of the concerns about novelty but did not defend the borderline accuracy of 3.5 mm for such a sensitive spinal surgery except to say it was their first attempt, so I cannot raise my ranking higher.



Author Feedback

We thank the reviewers and the editor(s) for their careful reading of our paper, and constructive suggestions. We have found that all comments were to the point. In the following, we respond to the major comments and respond to the main questions posed by the reviewers.

Novelty and Contribution (R3, R4): R4 comments about the novelty of our research, referencing papers that use robotic systems with rigid instruments for autonomous brain biopsies or drilling through hard tissue. However, our paper introduces a unique steerable drilling robotic framework using a continuum manipulator with flexible instruments for creating J-shaped (not straight) trajectories in spinal fixation procedures. To our knowledge, no other robotic system can autonomously create smooth curved drilling trajectories in the complex anatomy of the spine. Please see Figure 3 in our paper to fully appreciate the planned and obtained curvature of the drilling path.

We reviewed the articles mentioned by the reviewers and found that they all use rigid instruments limited to straight trajectories. The core contribution and novelty of our framework lies in using a flexible robotic system to enable J-shaped trajectories in complex anatomies like the spine. The flexibility of our system adds many benefits, but also significant complexity, which we have successfully addressed.

We acknowledge that several modules of our system are adapted from existing calibration and registration algorithms commonly used in robotics. Nonetheless, this does not diminish the novelty of our work. As R3 noted, our key contributions lie in “the system integration of a series of complex steps for image-guided spine surgery” and the first-time use of these modules in a novel steerable drilling system with flexible instruments. More advanced calibration and registration algorithms could always further enhance the performance of our framework.

Phantom Realism and Clinical Translation (R1): R1 had concerns about “the difference between a cadaver and the utilized phantom in the experiments.” We should clarify that the phantoms used in this study were designed and fabricated based on CT scans of a real patient obtained under an approved IRB protocol, to ensure realistic scale of the used vertebra. Regarding the bio-properties, the vertebral body section of the phantom was constructed from Sawbone PCF 5 block, which simulates the properties of an osteoporotic bone as experimentally evaluated in [4] of the submitted manuscript. Therefore, the utilized phantoms closely mimic realistic size, dimensions, and tissue properties and we believe the presented approach and framework can be translated for performing a cadaver study in the future.

Performance Accuracy (R1, R3): We appreciate the important comments from R1 and R3 regarding the accuracy of our studies and the explanation of the obtained errors. We especially thank R3 for their thoughtful comments and the referred review paper [A]. As mentioned by R3 and reference [A], medial pedicle perforation exceeding 4 mm may endanger neural elements, causing neurological deficits. Therefore, the overall errors we obtained (i.e., 3.5 mm) could still be clinically acceptable, considering this reference and given that this manuscript presents our first attempt using a novel robotic steerable drilling system for pedicle screw fixation.

Niche Application (R3): While we evaluate the system on it’s performance for spinal fixation, this system is capable of being used for other applications such as: ACL repairs, pelvic fixations, etc. The key feature of the framework is to enable access to regions within hard tissues that are inaccessible with current rigid instruments. Such applications are numerous and not having the choice of using steering instruments instead of rigid one is a major shortcoming we suggest to overcome in this paper.



Meta-Review

Meta-review #1

  • After you have reviewed the rebuttal and updated reviews, please provide your recommendation based on all reviews and the authors’ rebuttal.

    Accept

  • Please justify your recommendation. You may optionally write justifications for ‘accepts’, but are expected to write a justification for ‘rejects’

    Although some issues related to the system’s accuracy remain, this paper has significant merits. A reviewer have maintained the concern about the novelty of this paper, but it seems addressed in the rebuttal.

  • What is the rank of this paper among all your rebuttal papers? Use a number between 1/n (best paper in your stack) and n/n (worst paper in your stack of n papers). If this paper is among the bottom 30% of your stack, feel free to use NR (not ranked).

    Although some issues related to the system’s accuracy remain, this paper has significant merits. A reviewer have maintained the concern about the novelty of this paper, but it seems addressed in the rebuttal.



Meta-review #2

  • After you have reviewed the rebuttal and updated reviews, please provide your recommendation based on all reviews and the authors’ rebuttal.

    Accept

  • Please justify your recommendation. You may optionally write justifications for ‘accepts’, but are expected to write a justification for ‘rejects’

    Two reviewers recommend acceptance (weak) of this medical robotics paper. The third reviewer rated it as tring reject due to lack of novelty. However s/he missed the fact that the system includes unique steerable drilling continuum manipulator with flexible instruments for creating J-shaped (not straight) trajectories in spinal fixation procedures. This is a key point and has novelty. I thus recommend acceptingthe paper.

  • What is the rank of this paper among all your rebuttal papers? Use a number between 1/n (best paper in your stack) and n/n (worst paper in your stack of n papers). If this paper is among the bottom 30% of your stack, feel free to use NR (not ranked).

    Two reviewers recommend acceptance (weak) of this medical robotics paper. The third reviewer rated it as tring reject due to lack of novelty. However s/he missed the fact that the system includes unique steerable drilling continuum manipulator with flexible instruments for creating J-shaped (not straight) trajectories in spinal fixation procedures. This is a key point and has novelty. I thus recommend acceptingthe paper.



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