A three-dimensional finite element analysis on the effects of implant materials and designs on periprosthetic tibial bone resorption

Hyung Jun Park; Tae Soo Bae; Seung-Baik Kang; Hyeong Ho Baek; Moon Jong Chang; Chong Bum Chang

doi:10.1371/journal.pone.0246866

Peer Review History

Original SubmissionNovember 3, 2020
23 Nov 2020 Decision Letter - Jose Manuel Garcia Aznar, Editor PONE-D-20-34669 A three-dimensional finite element analysis on the effects of implant materials and designs on periprosthetic tibial bone resorption PLOS ONE Dear Dr. Kang, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Jan 07 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. 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Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Jose Manuel Garcia Aznar Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf 2. Please provide additional details regarding patient consent for the CT images to be used for building the proximal tibia model in this research. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 3. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 4. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 5. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: Many thanks for the consideration to review this interesting article proposal. It deals with a well as relevant topic of interest. Although my first suggestion would be to towards acceptance, please consider the concerns summarize as follows. General Suggestions: 1. Clearly point out that this is a N=1 virtual perturbation study in the abstract and the introduction as well. 2. Consider the recommendations given in Erdemir, A., Guess, T. M., Halloran, J., Tadepalli, S. C., & Morrison, T. M. (2012). Considerations for reporting finite element analysis studies in biomechanics. Journal of biomechanics, 45(4), 625-633. Viceconti, M., Olsen, S., Nolte, L. P., & Burton, K. (2005). Extracting clinically relevant data from finite element simulations. Clinical Biomechanics, 20(5), 451-454. 3. Are the bone and implant geometries available (for further research comparisons)? 4. Please list the material properties in detail: Young's modulus, Poisson number, etc. 5. Please elaborate on the mesh configuration of bone and implants. 6. Could you quantify the structural stiffness of the different implants (cross-sectional area, area moments, etc.)? 7. Assumptions such as full bonding of interfaces should be justified in the text. 8. Check English spelling. Major concerns: 1. Reporting of modeling details is insufficient, this includes: a) mesh configuration (number elements, nodes, element types, mesh convergence) b) boundary conditions (only loading is described without describing application in detail [point loads?], displacement constraints are missing) c) geometries are only partially described, missing structural stiffness, some size dimensions (name implant type and size?) d) Simulation software (solver, post-processing) is not clear e) Validation was not performed, this should be justified f) Material properties should be listed in detail and not only referenced Detailed comments l.98 "heterogenetic"? Did you mean heterogeneous? l.112-3 is redundant with l.128-30, although a reference was added, are this in-vivo measured loads? l.142-3 is redundant with l.149ff; Figure legends do not add much information, please rather describe the figures in more detail. Add additional information directly on the figures, by this you can avoid confusion. l.156 should be in the discussion, please just list the results first, before summarizing it l.216 Please rephrase: “Studies have reported medial periprosthetic tibial bone resorption after TKA using implants with stiffer materials l.217-220 Do not forget the exchanging loading in an in-vivo situation. Although you considered a realistic 60/40 ratio, this is not always true and change according to the activities. ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: Yes:** Philippe Moewis [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0246866.r001
Revision 1
4 Jan 2021 Author Response 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf -> We have reviewed the sample of the manuscript and authors affiliation form. 2. Please provide additional details regarding patient consent for the CT images to be used for building the proximal tibia model in this research. In the ethics statement in the Methods and online submission information, please ensure that you have specified (1) whether consent was informed and (2) what type you obtained (for instance, written or verbal, and if verbal, how it was documented and witnessed). -> We have added the informed consent from the patient on the method section. (Line 151-153) General Suggestions: 1. Clearly point out that this is a N=1 virtual perturbation study in the abstract and the introduction as well. -> We totally agreed with the reviewer’s comment. we have added what the reviewer commented. (Line 25-26, Line 86-87) 2. Consider the recommendations given in Erdemir, A., Guess, T. M., Halloran, J., Tadepalli, S. C., & Morrison, T. M. (2012). Considerations for reporting finite element analysis studies in biomechanics. Journal of biomechanics, 45(4), 625-633. Viceconti, M., Olsen, S., Nolte, L. P., & Burton, K. (2005). Extracting clinically relevant data from finite element simulations. Clinical Biomechanics, 20(5), 451-454. - > We thank the reviewer for the recommendation. 3. Are the bone and implant geometries available (for further research comparisons)? -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added geometries on table 1. (Line 141-142) 4. Please list the material properties in detail: Young's modulus, Poisson number, etc. -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added material properties on table 2. (Line 143-144) 5. Please elaborate on the mesh configuration of bone and implants. -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added mesh convergence test (Line 133-137) and mesh configuration on table 3. (Line 145-146) 6. Could you quantify the structural stiffness of the different implants (cross-sectional area, area moments, etc.)? -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added geometries on table 1. (Line 141-142) 7. Assumptions such as full bonding of interfaces should be justified in the text. -> Thank you for your commenting. As the reviewer’s comment, we clarified that the components and cement were full bonded and not to be displaced. (Line 129-130) 8. Check English spelling. -> Thank you for your commenting. We have carefully reviewed the manuscript. Major concerns: 1. Reporting of modeling details is insufficient, this includes: a) mesh configuration (number elements, nodes, element types, mesh convergence) -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added mesh convergence test (Line 133-137) and mesh configuration on table 3. (Line 145-146) b) boundary conditions (only loading is described without describing application in detail [point loads?], displacement constraints are missing) -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we clarified that the components and cement were full bonded and not to be displaced. (Line 129-130). The axial force was applied on the point of proximal tibial model. (Line 149-151). c) geometries are only partially described, missing structural stiffness, some size dimensions (name implant type and size?) -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added geometries on table 1. (Line 141-142) d) Simulation software (solver, post-processing) is not clear -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added what we used in post-processing program. (Line 137) e) Validation was not performed, this should be justified -> We totally agreed with the reviewer’s comment. We also thought that validation was important issue in the virtual perturbation study. However, as the study was performed using clinical images of CT, validation was difficult to be done. Therefore, we selected the convergence test as the tool of justifying. Because the error in strain was less than 3% in our study, we considered that the findings of our study was reasonable. (Line 133-137) f) Material properties should be listed in detail and not only referenced -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have added material properties on table 2. (Line 143-144) Detailed comments l.98 "heterogenetic"? Did you mean heterogeneous? -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we clarified what we wanted to express in the word ‘hetrogenetic’. Because the proximal tibia was consisted of cortical and cancellous bone, the structural material of the proximal tibia was not homogenous. To reflect the characteristics of in-vivo, the proximal tibia model was reconstructed using CT images. (Line 102-105). l.112-3 is redundant with l.128-30, although a reference was added, are this in-vivo measured loads? -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have deleted the redundant sentences. l.142-3 is redundant with l.149ff; Figure legends do not add much information, please rather describe the figures in more detail. Add additional information directly on the figures, by this you can avoid confusion. -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have deleted the redundant sentences. l.156 should be in the discussion, please just list the results first, before summarizing it -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have re-positioned that in the discussion section. (Line 272-273) l.216 Please rephrase: “Studies have reported medial periprosthetic tibial bone resorption after TKA using implants with stiffer materials -> We totally agreed with the reviewer’s comment. As the reviewer’s comment, we have changed. (Line 236-237) l.217-220 Do not forget the exchanging loading in an in-vivo situation. Although you considered a realistic 60/40 ratio, this is not always true and change according to the activities. -> We totally agreed with the reviewer’s comment. we have added what the reviewer’s comment to our one of the limitations. (Line 303-305) Attachments Attachment Submitted filename: Author response (review 1st).docx https://doi.org/10.1371/journal.pone.0246866.r002
28 Jan 2021 Decision Letter - Jose Manuel Garcia Aznar, Editor A three-dimensional finite element analysis on the effects of implant materials and designs on periprosthetic tibial bone resorption PONE-D-20-34669R1 Dear Dr. Kang, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Jose Manuel Garcia Aznar Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: All comments have been addressed ******** 2. Is the manuscript technically sound, and do the data support the conclusions? The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented. Reviewer #1: Yes ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: N/A ****** 4. Have the authors made all data underlying the findings in their manuscript fully available? The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified. Reviewer #1: Yes ****** 5. Is the manuscript presented in an intelligible fashion and written in standard English? PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here. Reviewer #1: Yes ****** 6. Review Comments to the Author Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters) Reviewer #1: (No Response) ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No https://doi.org/10.1371/journal.pone.0246866.r003
Formally Accepted
1 Feb 2021 Acceptance Letter - Jose Manuel Garcia Aznar, Editor PONE-D-20-34669R1 A three-dimensional finite element analysis on the effects of implant materials and designs on periprosthetic tibial bone resorption Dear Dr. Kang: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Jose Manuel Garcia Aznar Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0246866.r004

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