Dear Dr. Yoshii,

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 Feb 16 2026 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.. 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.. 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.. 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.

• A letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols....

We look forward to receiving your revised manuscript.

Kind regards,

Koji Akeda

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 note that funding information should not appear in any section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript.

3. We note that you have indicated that there are restrictions to data sharing for this study. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For more information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions.

Before we proceed with your manuscript, please address the following prompts:

a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information, data are owned by a third-party organization, etc.) and who has imposed them (e.g., a Research Ethics Committee or Institutional Review Board, etc.). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent.

b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. For a list of recommended repositories, please see

https://journals.plos.org/plosone/s/recommended-repositories. You also have the option of uploading the data as Supporting Information files, but we would recommend depositing data directly to a data repository if possible.

We will update your Data Availability statement on your behalf to reflect the information you provide.

4. If the reviewer comments include a recommendation to cite specific previously published works, please review and evaluate these publications to determine whether they are relevant and should be cited. There is no requirement to cite these works unless the editor has indicated otherwise.

5. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

The manuscript entitled ‘Mini-plate versus Suture-Anchor in Double-door Laminoplasty for Degenerative Cervical Myelopathy: Protocol for a Multicenter, Non-Inferiority, Randomized Controlled Trial’ aims to assess the non-inferiority of the suture-anchor method compared to the mini-plate method in the point of clinical outcomes for the primary endpoint. This study also evaluates the radiological outcomes, perioperative complications and medical costs for secondary outcomes.

Thank you for submitting this well-designed study protocol, which explores a clinically relevant question regarding mini-plate applications in cervical spine surgery. The reviewers have provided constructive feedback to strengthen the manuscript; please address their comments in your revision.

[Note: HTML markup is below. Please do not edit.]

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Partly

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete??>

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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.requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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: No

Reviewer #2: No

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

Reviewer #1: I appreciate the opportunity to review this interesting protocol manuscript. DCM is a major societal problem, and since surgical treatment is often unavoidable, re-evaluating optimized treatment strategies from an objective perspective is critically important. The authors have designed the RCT appropriately and are investing considerable effort to evaluate numerous clinically important outcomes. This effort is commendable, and I eagerly await the results.

That said, some portions warrant improvement or clarification. I would appreciate the authors' thoughts on the points outlined below.

1.

Upon reviewing this RCT, I cannot definitively state that the title is accurate. Is this device (LAMINAclip2) truly a "mini-plate"? Judging from the photos, it appears more like a block than a plate. Furthermore, it seems designed to be inserted into a protrusion of the screw embedded in the lamina, rather than being fixed to the lamina with screws. To me, the mechanism of this device seemed closer to a threaded HA spacer than a plate-screw system.

Plate-screw systems derive their fixation force from the static friction generated by the plate being pressed tightly against the bone by the torque of the screws. Alternatively, in a locking plate system, the device achieves mechanical properties similar to external fixation through the locking of the plate and screws. Does the LAMINAclip2 possess such mechanical characteristics?

While this is my personal opinion, I believe the title creates a gap between what readers might expect and the actual content.

Therefore, how about considering the following?: Provide evidence demonstrating that this device possesses the same biomechanical characteristics as the plate-screw system, replace "mini-plate" with an appropriate term, or simply use a mini-plate system in the control group.

2.

I recommend including cervical range of motion (ROM) in pre- and postoperative radiographic evaluations. This is because the importance of cervical ROM has gained increasing attention in recent years when exploring risk factors for postoperative cervical kyphosis.

- Fujishiro T, Obo T, Yamamoto Y, et al. J Clin Neurosci 2024

- Ren H, Shen X, Ding R, et al. Spine. 2023

3.

The term "fixation" is used several times in the text. I cannot dismiss the concern that using this term alone might lead readers to misunderstand this paper as discussing "cervical fusion surgery." Therefore, please ensure it is made absolutely clear that the paper describes a fixation method specifically for the opened lamina. The phrase should be written as "the fixation method for the opened lamina," not simply "the fixation method."

Once again, I wish to state that the authors' efforts are commendable. I am very much looking forward to the results.

Reviewer #2: Thank you for a well presented study.

I have some minor clarifications.

Abstract: consider re-phrasing "and even exist potential complications"

line 142 and 262 and 314: gender - is it gender or sex? Fig 2 indicates it is male/ female - use sex rather than gender, and indicate it is sex at birth somewhere if this is what is intended.

line 261: what is the definition for the FAS?

line 267: what is the definition for the SAS?

line 266: analysing for differences in randomised group by chi-squared test will not account for the stratification variables - consider logistic regression. Please specify that all analyses by randomised group will appropriately consider the stratification variables.

line 281: "is associated with" rather than "correlates"

Reviewer #3: This manuscript presents a well-designed protocol for a multicenter randomized controlled trial comparing suture-anchor–based and mini-plate–based double-door laminoplasty for degenerative cervical myelopathy. The study addresses a clinically relevant question , and the overall study design, endpoints, and statistical analysis plan are appropriate. I have the following two minor comments.

1. Management of intraoperative hinge fractures In double-door laminoplasty, intraoperative hinge fractures can occur, which may make it difficult to evaluate bone union. The protocol should clarify how these cases will be handled. Specifically, please state whether these cases will remain eligible for evaluation or be treated as protocol deviations. Please also clarify how they will be analyzed (e.g., intention-to-treat).

2. Rationale for the non-inferiority margin According to the CONSORT extension for noninferiority trials, the rationale for the non-inferiority margin should be stated. The current protocol uses a 20% margin based on the MCID. However, further clinical rationale for selecting "20%" would be helpful. For example, please explain if this 20% margin is consistent with previous studies, or if it is an acceptable difference considering the potential benefits of the suture-anchor technique (such as shorter operative time or lower cost).

**********

what does this mean?). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). 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 For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our Privacy Policy..-->

Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

**********

[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.]

To ensure your figures meet our technical requirements, please review our figure guidelines: https://journals.plos.org/plosone/s/figures

You may also use PLOS’s free figure tool, NAAS, to help you prepare publication quality figures: https://journals.plos.org/plosone/s/figures#loc-tools-for-figure-preparation.

NAAS will assess whether your figures meet our technical requirements by comparing each figure against our figure specifications.

Clip-plate versus Suture-Anchor in Double-door Laminoplasty for Degenerative Cervical Myelopathy: Protocol for a Multicenter, Non-Inferiority, Randomized Controlled Trial

PONE-D-25-63840R1

Dear Dr. Yoshii,

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 will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact  and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact  and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact  and clicking the ‘Update My Information' link at the top of the page. For questions related to billing, please contact billing support....

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,

Koji Akeda

Academic Editor

PLOS One

Additional Editor Comments (optional):

Thank you very much for submitting your highly valuable research protocol.

We sincerely appreciate your careful responses to the reviewers' comments.

We are pleased to inform you that your manuscript has been accepted for publication in PolsOne Journal. We look forward to your continued contributions in the future.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

Reviewer #1: Yes

Reviewer #3: Yes

**********

2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>

Reviewer #1: Yes

Reviewer #3: Yes

**********

3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>

Reviewer #1: Yes

Reviewer #3: Yes

**********

4. Have the authors described where all data underlying the findings will be made available when the study is complete??>

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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.requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. 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

Reviewer #3: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #3: Yes

**********

Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

Reviewer #1: I extend my gratitude to the authors for their sincere consideration of my opinions. This process has also updated my knowledge and proved highly valuable.

The literature on the mechanical properties of Laminaclip2 is interesting. I also gained insight into the situation by learning that it is managed as a type of plate in the authors' country. The term “clip-plate” strikes me as a good designation, clearly indicating it addresses different material properties than conventional miniplates while suggesting a plate system-like outcome.

The other revisions also seem satisfactory, reducing the potential for reader confusion.

Once again, I express my respect for the authors' efforts and wish this research every success.

Reviewer #3: The authors have adequately addressed the points raised during the previous review. The revised protocol is clear and well-prepared, and I believe no further comments are necessary from the reviewer’s perspective.

**********

what does this mean?). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). If published, this will include your full peer review and any attached files.). 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 For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our For information about this choice, including consent withdrawal, please see our Privacy Policy..-->

Reviewer #1: No

Reviewer #3: No

**********