Re-Evaluating the Long-Term Efficacy of Semi-Rigid Fixation Using a Nitinol Spring Rod in Lumbar Surgery: A Retrospective Study on an Effective Alternative for Reducing Adjacent Segment Disease

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Congratulations for the paper. My comments are:

 

·       Authors must include the design of the paper in the title.

·       The abstract must have the sections that the journal guide proposes.

·       The introduction section is very short. Authors must substantiate their topic well. For example, the authors cite 8 references (2-10) in the same sentence. They should explain the text better.

·       Line 53. Authors should remove "Table 1."

·       The footer of table 1 does not indicate well what the table expresses

·       The p value values in Table 2 do not have the same number of decimal

·       The objective of the study must be clearer. Authors must explain it better.

·       The discussion section must begin with the main finding of the study. They should not repeat information that has already been exposed in the text

·       Authors must include a clinical applications section in order to determine the practical purpose for therapists.

·       In limitation section, authors must explain better the text.

·       The conclusion must be simpler and more concrete. They must write 2-3 lines with their main contribution

·       The style of references is correct.

Comments on the Quality of English Language

The text must have greater scientific rigor

Author Response

Thank you for your comments, and the considerable efforts you have made to help us improve the text. I hope that we have managed to address your suggestions sufficiently.

Author Response File: Author Response.docx

Reviewer 2 Report

Comments and Suggestions for Authors

This study addresses the long-term outcomes of Nitinol spring rod semi-rigid fixation, a potential alternative to traditional rigid fixation, in reducing the incidence of adjacent segment disease (ASD). The retrospective case study evaluated 89 patients who underwent lumbar or lumbosacral surgeries using a combination of Bioflex® (a Nitinol spring rod dynamic stabilization system) and an interbody cage over ten years of follow-up. The authors hypothesized that posteriorly placed Nitinol spring rods, combined with the stability provided by the anterior cage, will not hinder the achievement of fusion while potentially resulting in a lower incidence of Adjacent Segment Disease (ASD). This work documented and analyzed the long-term outcomes of using this method. The paper details the contribution to the ongoing discussion on spinal surgery techniques and the potential to redefine surgical strategies to improve patient outcomes in treating lumbar degenerative diseases. At the end of this work, the authors conclude that semi-rigid fixation using Bioflex with an interbody cage is a possibly effective treatment strategy to prevent ASD. The technique potentially reduces the risk of ASD by allowing a degree of movement at the surgical site. These findings and results may encourage the further exploration of semi-rigid fixation systems in spinal surgery, potentially improving outcomes for patients with degenerative lumbar diseases.

Besides this, certain sections of the article require major revisions based on the information available. I have highlighted the main details in the general, specific and other comments. Please refer to the attached document, which outlines the major issues identified in the manuscript.

Comments for author File: Comments.pdf

Author Response

Dear reviewer #2, 

 

 Unfortunately, it appears that the attached file pertains to a different paper you have reviewed. If you could please revise and resend the correct file, we will proceed with the necessary revisions.

 

Thank you.

Reviewer 3 Report

Comments and Suggestions for Authors

Dear authors,

The manuscript is in deed interesting. Please, find below my comments:

- I did not find the sample size calculation nor any post hoc power analysis. Please, clarify and include.

- Please, include the psychometric values (responsiveness, validity, reliability) of all outcome measures you performed.

- The introduction is too brief. Please, explore deeply the outcome variables you already have, and the advantages and the clinical meaning of the studied technique.

- The results are clear.

- Start the discussion with a summary of your results. Then, compare the current results with other techniques.

- Expand the limitations. As you said, there are several, thus discuss them accordingly. 

- Caution with your conclusions. Avoid any spin and address the current results considering the limitations.

Comments on the Quality of English Language

The manuscript would benefit from a native speaker editing.

Author Response

Thank you for your comments, and the considerable efforts you have made to help us improve the text. I hope that we have managed to address your suggestions sufficiently.

Author Response File: Author Response.docx

Reviewer 4 Report

Comments and Suggestions for Authors

This retrospective study examines the long-term outcomes of patients who underwent lumbar fixation surgery employing semi-rigid fixation utilizing a Nitinol spring rod and an interbody cage. The study delves into a pertinent and intriguing subject matter. Overall, the manuscript is well written. However, there are several points that merit attention prior to publication.

1) Firstly, elucidating the criteria guiding the selection of patients eligible for semi-rigid fixation would enhance the comprehensiveness of the study. For example, clarification regarding the utilization of specific scoring systems to assess the propensity of patients toward ASD would contribute valuable insights.

2) Secondly, inclusion of patients' body mass index (BMI) data is imperative, as it represents a significant determinant influencing patient outcomes following lumbar fixation surgery. Incorporating BMI information would bolster the robustness of the analysis and facilitate a more comprehensive understanding of the factors impacting patient recovery.

3) Regarding the discussion section, a typographical error is noted in paragraph two, line 210, where the value "15,9%" appears. It should be 16.9%.

4) There is a mistake in the Informed Consent Section, in the structure of the sentence (“...waived due to waived in view of the retrospective…) 

5) How did the authors verify data distribution normality? Can you please include further details of the test used in the appropriate statistics section?

Comments on the Quality of English Language

English language is fine, only few small errors encountered.

Author Response

Thank you for your comments, and the considerable efforts you have made to help us improve the text. I hope that we have managed to address your suggestions sufficiently.

Author Response File: Author Response.docx

Round 2

Reviewer 2 Report

Comments and Suggestions for Authors

 

Dear authors,

Thank you for the invested time and several improvements in the article. Still, certain sections of the article require significant revisions based on the information available. I have highlighted the main details in following comments. Please refer to the attached document, which outlines the issues identified in the manuscript, or see the following comments:

General comments

Point 1: Pay attention to the quality of the Tables (formats, fonts, etc.) and Figures (sizes).

Point 2: Please ensure that the year of publication in the “References” section follows the guidelines for authors.

Point 3: Adding more citations from the last two years can improve the list of references.

Point 4: The size and data of Table 4 are on different pages. It is recommended that this Table, with the included data and notes under it, be prepared on one page.

Specific comments

Point 1: The text should be distributed evenly between the margins in all sections until the section “Conclusions.”

Point 2: In Lines 34, 36, 238, 246, 259 and 269, the text, two reference numbers should be placed in square brackets without any space between them, for example [1,3].

Point 3: Is there any reason for free textual space between Lines 39 and 40, 46 and 47, 243 and 244, 259 and 260, 271 and 272, 278 and 279, 301 and 303, 304 and 305, 310 and 313?

Point 4: In Line 53, a free space should be added between “failure” and [18].

Point 5: A free space between “rods” and the following comma in Line 57 should be added.

Point 6: Remove free space after “1.4 ± 0.6” and follow “the” in Line 80.

Point 7: Look at the format of “kg/m²” in Line 82. Part “m²” is written in a different font.

Point 8: Subsection “2.2. Surgical Procedure” should be separated from the notes in Lines 114 and 115.

Point 9: The tables’ titles in Lines 90, 197, 216 and 225 should be terminated with a full stop.

Point 10: I suggest excluding values from Table 1 for non-parametric distributions that are represented as the median with the interquartile range [25th percentile; 75th percentile]. What is the reason that these values should be announced, especially in this Table?

Point 11: A full stop should be added before “Percentages” in notes under Table 1.

Point 12: Look at the size of the spaces between Lines 142 and 145, 161 and 164, 295 and 298.

Point 13: If the first line indent was not used in other sections and subsections, then remove it from Line 177 in subsection “Results” or prepare all paragraphs of the article with one style.

Point 14: In Line 172, a full stop should be added after (Table 2) but not before. Please revise this place.

Point 15: In rows of Table 2, “Upper disc height change (%)” and “Lower disc height change (%)” are marked %, but why in columns and for % included values with mean ± standard deviation?

Point 16: Don`t capitalize the word “Statistically” in Line 198.

Point 17: Pay attention to the size of Figure 3 between Lines 199 and 200. It looks pretty compressed, and I suggest preparing it in a larger size.

Point 18: In Table 3, I recommend deleting the text “Measurement” in the column and replacing it with “Measurement of the angle.” The angle symbol should be located close to the SD value without any space (as it is from Line 209 until Line 212).

Point 19: The reference list should be prepared according to the ACS style guide and instructions for authors. The list of references should include journal abbreviations and DOI links.

Point 20: Please look at the format of the citations in Lines 385 and 386 and Lines 393 and 394. They look different from other citations.

Point 21: Remove one full stop from the end of the sentence in Line 316.

Point 22: A full stop should be added at the end of the sentence in Line 323 and Line 337.

Point 23: A free space should be added between lines 326 and 327.

Thank you.

 

 

Comments for author File: Comments.pdf

Author Response

Thank you for your comments, and the considerable efforts you have made to help us improve the text. I hope that we have managed to address your suggestions sufficiently.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

Thank you for your effort to improve the draft.