Review Reports - Operative Treatment of Adolescent Diaphyseal Clavicle Fracture: Elastic Stable Intramedullary Nail Versus Plate Fixation

Round 1

Reviewer 1 Report

Comments and Suggestions for Authors

Thank you very much for the opportunity to review this manuscript. The study addresses a clinically important question and clearly falls within the scope of Medicina. It has significant potential for publication, but several aspects need to be clarified or expanded. My detailed comments are outlined below:

Although this is a retrospective study, the Methods section should include a formal (a priori or post hoc) power calculation or sample‑size rationale. This will help readers determine whether the cohort was large enough to detect meaningful differences between ESIN and plate fixation, particularly for secondary endpoints and complication rates.

The authors report that ESIN achieved radiographic union approximately three weeks faster than plate fixation, attributing this to periosteal preservation. However, it remains unclear whether this translates into real‑world benefits, such as earlier return to sports, reduced analgesic use, or faster discharge from physical therapy. I recommend either presenting any available data on these functional timelines or, if such data were not collected, discussing this as a limitation and suggesting prospective collection in future studies.

QuickDASH provides a useful snapshot of upper‑extremity function, but it does not capture other critical domains such as pain intensity, cosmetic satisfaction, or overall quality of life. Given the retrospective design, the authors should report any additional PROMs that may have been collected—such as a VAS for pain, or a quality‑of‑life instrument (e.g., PedsQL)—and, if these data are not available, acknowledge this gap and propose their inclusion in future prospective work.

The manuscript rightly notes its retrospective design, small sample size, and lack of cosmetic outcome measures. To strengthen the discussion, the authors should further elaborate on how the single‑center setting and institution‑specific surgical and rehabilitation protocols might limit external validity. Addressing whether variations in surgeon experience, postoperative care pathways, or patient demographics at other institutions could influence outcomes will help readers gauge the broader applicability of these findings.

Author Response

Manuscript ID: medicina-3758090

Title: Operative Treatment of Adolescent Diaphyseal Clavicle Fracture: Elastic Stable Intramedullary Nail versus Plate Fixation

The responses to the reviewers’ comments are presented in blue letters, and changes are highlighted in the manuscript.

Dear Editorial Board of Medicina

On behalf of my co-authors, I am pleased to submit the revised version of the manuscript for your kind reconsideration for publication in Medicina.

I sincerely thank to the editorial board and the three reviewers for valuable comments and suggestions during the review process. Their insights have significantly improved the quality of our manuscript. I believe that the revised version will be helpful for the journal’s readers for planning the surgical treatment of adolescent diaphyseal clavicle fracture.

I would also like to let you know that we had our English language edited professionally by Editage before we submitted our manuscript. I have included the certificate of English editing for your information. But if you think more improvements are needed, please let me know.

I hope that our updated submission is now ready to be published in Medicina, and I look forward to hearing back from you.

Sincerely,

Yoon Hae Kwak, MD, PhD

Department of Orthopaedic Surgery, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul 05505, Republic of Korea

Tel.: +82-2-3010-3536

E-mail: y.h.kwak@amc.seoul.kr

Reviewer:1

Comments 1: Thank you very much for the opportunity to review this manuscript. The study addresses a clinically important question and clearly falls within the scope of Medicina. It has significant potential for publication, but several aspects need to be clarified or expanded. My detailed comments are outlined below:

Response 1: Thank you for your invaluable time and effort during the review process. This will aid our research and provide a better understanding of the journal's readers.

We totally agree that the sample size is a really important issue when it comes to understanding the study's findings. So, we did a post hoc power analysis using the G*Power 3.1 program, based on the observed difference in means (Cohen's d = 1.49) between the ESIN and plate fixation groups. With a total sample size of 35 and a significance level of 0.05, the calculated power was 0.99.

[Post hoc power analysis result]

We added this information to the Materials and Methods section.

Revision:

Materials and Methods, Line 74 to 77

Comments 2: The authors report that ESIN achieved radiographic union approximately three weeks faster than plate fixation, attributing this to periosteal preservation. However, it remains unclear whether this translates into real‑world benefits, such as earlier return to sports, reduced analgesic use, or faster discharge from physical therapy. I recommend either presenting any available data on these functional timelines or, if such data were not collected, discussing this as a limitation and suggesting prospective collection in future studies.

Response 2: One of the key findings of our study id that ESIN achieved radiographic union approximately three weeks earlier than plate fixation group. As this was a retrospective study, we did not investigate functional outcomes related to this potential benefit, such as return to sports, reduced analgesic use, or faster discharge from physical therapy. As the reviewer rightly pointed out, we acknowledged this as a limitation and emphasized the need for prospective studies to investigate these clinically meaningful outcomes.

Revision

Discussion, Line 227 to 232

Comments 3: QuickDASH provides a useful snapshot of upper‑extremity function, but it does not capture other critical domains such as pain intensity, cosmetic satisfaction, or overall quality of life. Given the retrospective design, the authors should report any additional PROMs that may have been collected—such as a VAS for pain, or a quality‑of‑life instrument (e.g., PedsQL)—and, if these data are not available, acknowledge this gap and propose their inclusion in future prospective work.

Response 3: As this was the retrospective study, we couldn’t collect additional patient-reported outcome measures, such as pain intensity scores, cosmetic satisfaction, or passive range of motion data at one year postoperatively. However, we think that the QuickDASH score could provide a general evaluation of upper extremity function. It showed low scores in both groups, suggesting satisfactory functional recovery. Nonetheless, as you pointed out, the absence of specific assessments for pain and cosmetic outcomes represents a limitation of our study.

Therefore, we added this point to the 'Limitations' section and recommended that future studies address these important issues.

Revision:

Discussion, Line 290 to 298

Comments 4: The manuscript rightly notes its retrospective design, small sample size, and lack of cosmetic outcome measures. To strengthen the discussion, the authors should further elaborate on how the single‑center setting and institution‑specific surgical and rehabilitation protocols might limit external validity. Addressing whether variations in surgeon experience, postoperative care pathways, or patient demographics at other institutions could influence outcomes will help readers gauge the broader applicability of these findings.

Response 4: We totally agree with the reviewer's point about the limitations inherent to a single-center study design. Although our results showed that the ESIN group achieved outcomes comparable to those of plate fixation, we recognize that these results may reflect institution-specific factors, including surgical techniques and patient management strategies, which may differ in other clinical settings. Furthermore, as single-center studies involve consistent practices among a limited group of surgeons and healthcare staff, they carry the risk of unintentional bias, which could limit the external validity of the findings. The small sample size is also a limitation of the study. As you suggested, we have expanded the discussion to address how variations in other institutions could influence clinical outcomes. We have also emphasized the need for future multicenter studies with larger, more diverse populations to validate and generalize these results.

Revision:

Discussion, Line 283 to 288

Author Response File: Author Response.pdf

Reviewer 2 Report

Comments and Suggestions for Authors

The manuscript entitled "Operative Treatment of Adolescent Diaphyseal Clavicle Frac- 2 ture: Elastic Stable Intramedullary Nail versus Plate Fixation" studies the differences in outcome between two types of surgical techniques in adolescent clavicle fracture. The manuscript is well written and offer new insights to this relatively common pathology. The manuscript addresses the questions of what of the two treatments offers a better healing and a lower complication rate. The references are appropriate. I consider that the manuscript is valuable for both clinicians and researchers in the field.

Author Response

Manuscript ID: medicina-3758090

Title: Operative Treatment of Adolescent Diaphyseal Clavicle Fracture: Elastic Stable Intramedullary Nail versus Plate Fixation

The responses to the reviewers’ comments are presented in blue letters, and changes are highlighted in the manuscript.

Dear Editorial Board of Medicina

On behalf of my co-authors, I am pleased to submit the revised version of the manuscript for your kind reconsideration for publication in Medicina.

I hope that our updated submission is now ready to be published in Medicina, and I look forward to hearing back from you.

Sincerely,

Yoon Hae Kwak, MD, PhD

Department of Orthopaedic Surgery, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul 05505, Republic of Korea

Tel.: +82-2-3010-3536

E-mail: y.h.kwak@amc.seoul.kr

Reviewer 2.

Comment 1: The manuscript entitled "Operative Treatment of Adolescent Diaphyseal Clavicle Frac- 2 ture: Elastic Stable Intramedullary Nail versus Plate Fixation" studies the differences in outcome between two types of surgical techniques in adolescent clavicle fracture. The manuscript is well written and offer new insights to this relatively common pathology. The manuscript addresses the questions of what of the two treatments offers a better healing and a lower complication rate. The references are appropriate. I consider that the manuscript is valuable for both clinicians and researchers in the field.

Response 1: We appreciate your encouraging comments on our manuscript. We hope that our results will contribute to guiding treatment options for adolescent diaphyseal clavicular fractures and support clinical decision-making to the pediatric orthopedists. Your positive feedback motivates us to continue our efforts to improve the quality and relevance of our research.

Revision:

None.

Author Response File: Author Response.pdf

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Author

I am honored to have the opportunity to review this study.

General Comments:
Overall, the content of the manuscript is interesting, and the structure is well organized.

I have one question regarding implant removal. While the manuscript discusses early implant removal, it does not mention the overall implant removal rate. Including information about the implant removal rate and the reasons for removal would further strengthen the manuscript.

In many Asian countries, implant removal is often performed based on patient preference and is not necessarily considered a complication. However, in some European countries, implant removal is sometimes interpreted as implant failure. Clarifying this aspect would improve international readability and interpretation of your findings.

Methods

Operative Indications and Surgical Techniques

Did the patients in this study receive a standardized rehabilitation program? It is described that the patients had a sling immobilization for 4 weeks postoperatively. However, one of the advantages of surgical fixation using implants is the ability to initiate early mobilization. Could the authors clarify the rationale for maintaining immobilization for 4 weeks in their protocol? In particular, if this protocol is applied to youth patients, such as those aged 15 to 18 years, is there a risk of joint stiffness due to prolonged immobilization?

Statistical analysis

It was described that the continuous variables were assessed with Mann-Whitney U test. Since this is a non-parametric test, it is generally more appropriate to present the data as median and interquartile range rather than mean values. Is there a specific reason why the authors chose to present the results using means? If there is no particular justification, I recommend revising the data presentation to reflect medians and interquartile ranges.

Results

It is described that 17 patients in this study underwent surgery for absolute indication in the Methods. How many patients had open fracture or neurovascular injury in each group? Please clarify them.

In general, segmental fractures can be treated with ESIN, while multifragmentary fractures are, in my opinion, more appropriately managed with plate fixation. Would it be possible for the authors to differentiate between these fracture types in the manuscript? Alternatively, I suggest classifying the fracture patterns using the AO/OTA classification system for greater clarity.

Regarding the amount of shortening at 1 year postoperatively, the standard deviation appears relatively high compared to the mean value, suggesting considerable variability in the data. In such cases, I recommend reconsidering the method of data presentation, as an alternative format (e.g., median and interquartile range) may more accurately reflect the distribution.

According to Table3, almost no patients experienced chest wall numbness in the plate group. Previous studies have reported that a certain proportion of patients experience cutaneous numbness, especially in cases where MIPO is not used. Did the authors employ any specific surgical tips in this study to minimize the risk of cutaneous sensory disturbances?

Park JS, Ko SH, Hong TH, Ryu DJ, Kwon DG, Kim MK, Jeon YS. Plate fixation versus titanium elastic nailing in midshaft clavicle fractures based on fracture classifications. J Orthop Surg (Hong Kong). 2020 Sep-Dec;28(3):2309499020972204. doi: 10.1177/2309499020972204. PMID: 33258399.

Discussions

Postoperative outcomes

Suzuki M, Kurimoto S, Shinohara T, Tatebe M, Imaeda T, Hirata H. Development and validation of an illustrated questionnaire to evaluate disabilities of the upper limb. J Bone Joint Surg Br. 2010 Jul;92(7):963-9. doi: 10.1302/0301-620X.92B7.23410. PMID: 20595115.

I would like to thank you again for giving me this valuable chance.

Sincerely,

Author Response

Manuscript ID: medicina-3758090

Title: Operative Treatment of Adolescent Diaphyseal Clavicle Fracture: Elastic Stable Intramedullary Nail versus Plate Fixation

The responses to the reviewers’ comments are presented in blue letters, and changes are highlighted in the manuscript.

Dear Editorial Board of Medicina

On behalf of my co-authors, I am pleased to submit the revised version of the manuscript for your kind reconsideration for publication in Medicina.

I hope that our updated submission is now ready to be published in Medicina, and I look forward to hearing back from you.

Sincerely,

Yoon Hae Kwak, MD, PhD

Department of Orthopaedic Surgery, Asan Medical Center Children’s Hospital, University of Ulsan College of Medicine, 88, Olympic-ro, 43-gil, Songpa-gu, Seoul 05505, Republic of Korea

Tel.: +82-2-3010-3536

E-mail: y.h.kwak@amc.seoul.kr

Reviewer 3.

Comments 1: Dear Author

I am honored to have the opportunity to review this study.

General Comments:

Overall, the content of the manuscript is interesting, and the structure is well organized. I have one question regarding implant removal. While the manuscript discusses early implant removal, it does not mention the overall implant removal rate. Including information about the implant removal rate and the reasons for removal would further strengthen the manuscript.

Response 1 : Thank you for your invaluable time and effort in reviewing our manuscript. We believe that your comments will greatly contribute to improving our work and enhancing understanding among readers of Medicina.

In our institution, the standard protocol for pediatric diaphyseal clavicular fracture surgery is to recommend implant removal at one year after confirming bone union with x-ray. There are several reasons for the implant removal. First, in South Korea, many patients and their guardians prefer to remove implants after bone union because they regard the hardware as a foreign object that is not a natural part of the body. Second, the more important thing is, our patient population are adolescents. Unlike adults, they have many years of life ahead of them. If complications such as infection around the implant or refracture due to trauma occur during their remaining growth period, implant removal at that stage could become more challenging. Therefore, we routinely recommend implant removal once bone union is achieved, and all patients in our cohort agreed to this protocol. Consequently, the implant removal rate in our series was 100% when they follow up at 1 year.

We have added an explanation of this protocol and its rationale in the revised manuscript to clarify this point.

Revision:

Materials and Methods, Line 103 to 110

Comments 2: Operative Indications and Surgical Techniques

Response 2: We apologize for not providing a detailed description of our postoperative rehabilitation protocol in the original manuscript.

As our patients are adolescents, we advised the use of arm sling for 4 weeks postoperatively in outdoor settings especially in the school to protect the fracture site from unintended trauma to prevent re-fracture.

However, to prevent joint stiffness, we encouraged early pendulum exercises as soon as possible. In addition, at 2 weeks postoperatively, patients were instructed to remove the sling while indoors and begin active shoulder exercises within a pain-free range. Until 4 weeks, we restricted lifting heavy objects and elevation of the arm beyond 90° in forward flexion or abduction.

This rehabilitation protocol allowed for a balance between protecting the fracture site and promoting early mobilization, and no cases of shoulder stiffness were observed.

We included this detailed rehabilitation protocol in the revised Materials and Methods section.

Revision:

Materials and Methods, Line 96 to 101

Comments 3: Statistical analysis It was described that the continuous variables were assessed with Mann-Whitney U test. Since this is a non-parametric test, it is generally more appropriate to present the data as median and interquartile range rather than mean values. Is there a specific reason why the authors chose to present the results using means? If there is no particular justification, I recommend revising the data presentation to reflect medians and interquartile ranges.

Response 3: We used Mann-Whitney U test in this study, being a non-parametric test, is more appropriate for data presented as medians and interquartile ranges rather than means and standard deviations. Therefore, we have revised all data to be presented as medians with interquartile ranges.

Revisions:

1.Abstract, Line 25, 26

Methods: Line 132
Results, Line 139 to 140
Results, Line 151 to 157
Table 1, 2, 3

Comments 4: Results

Response 4: As the reviewer pointed out, absolute indications for clavicle surgery in our protocol include open fractures and neurovascular injuries. In this study, however, there was no case of neurovascular injury, and only one case of open fracture. This open fracture was a pinpoint skin perforation caused by a segmental fragment (Gustilo-Anderson type I), and was managed with immediate debridement and fixation using ESIN with no delay to treatment. This case did not result in any postoperative complications.

Although neurovascular injury was one of the absolute indications for surgery in our institutional protocol, there were no such cases in our cohort. Therefore, it was not included in the manuscript. This point has now been clarified in the Materials and Methods and Results sections.

Revision:

Materials and Methods, Line 81 to 82
Results, Line 141 to 143

Comments 5: In general, segmental fractures can be treated with ESIN, while multifragmentary fractures are, in my opinion, more appropriately managed with plate fixation. Would it be possible for the authors to differentiate between these fracture types in the manuscript? Alternatively, I suggest classifying the fracture patterns using the AO/OTA classification system for greater clarity.

Response 5: We agree your opinion that segmental fractures (which we initially described as simple fractures) may be well suitable for treatment with ESIN, while multifragmentary fractures could be more appropriately treated with plate fixation considering its anatomical characteristics. However, in our practice, we did not strictly differentiate between these fracture types when selecting the surgical methods. In adolescent patients, the periosteum of clavicle is thicker compared to adults, which may allow ESIN to be applied even in multifragmentary fractures; nevertheless, we recognize that further studies are needed to validate this.

In response to the reviewer’s suggestion, we classified the fractures according to the AO/OTA system for greater clarity. Fractures were grouped as 15-2A (simple), and 15-2B and 15-2C (wedge and segmental). We compared these classifications between the two treatment groups and found no significant differences. We have revised the manuscript to include these modifications

Revision:

Materials and Methods, Line 116 to 117
Table 1

Comments 6: Regarding the amount of shortening at 1 year postoperatively, the standard deviation appears relatively high compared to the mean value, suggesting considerable variability in the data. In such cases, I recommend reconsidering the method of data presentation, as an alternative format (e.g., median and interquartile range) may more accurately reflect the distribution.

Response 6: As following your suggestion, we changed all mean with standard deviation data to median and interquartile range.

Revisions:

1.Abstract, Line 25, 26

Materials and Methods: Line 132
Results, Line 139 to 140
Results, Line 151 to 157
Table 1, 2

Comments 7: According to Table3, almost no patients experienced chest wall numbness in the plate group. Previous studies have reported that a certain proportion of patients experience cutaneous numbness, especially in cases where MIPO is not used. Did the authors employ any specific surgical tips in this study to minimize the risk of cutaneous sensory disturbances? Park JS, Ko SH, Hong TH, Ryu DJ, Kwon DG, Kim MK, Jeon YS. Plate fixation versus titanium elastic nailing in midshaft clavicle fractures based on fracture classifications. J Orthop Surg (Hong Kong). 2020 Sep-Dec;28(3):2309499020972204. doi: 10.1177/2309499020972204. PMID: 33258399.

Response 7: As noted in your cited study, the incision length for plate fixation was approximately 8 to10 cm. In contrast, the average incision length in our study was relatively shorter, about 6 to 8 cm. We believe this smaller incision, combined with limited soft tissue dissection for plate exposure, may have contributed to a lower risk of injury to the supraclavicular nerve. Moreover, numbness was assessed at 1 year postoperatively rather than in the acute phase. It is also possible that adolescents recover more rapidly and completely from iatrogenic nerve injuries than adults due to their superior healing power.

We have added this explanation to the Discussion section.

Revision:

Discussion, Line 257 to 263

Discussions

Comments 8: Postoperative outcomes

In this study, you evaluated DASH score which is patient reported assessment tool for functional outcomes. Did you evaluate any objective outcomes such as ROM of shoulder? Some previous reports indicated that DASH score is recommended for assessment disorders of the upper limb in patients aged from 18 to 65 years. Suzuki M, Kurimoto S, Shinohara T, Tatebe M, Imaeda T, Hirata H. Development and validation of an illustrated questionnaire to evaluate disabilities of the upper limb. J Bone Joint Surg Br. 2010 Jul;92(7):963-9. doi: 10.1302/0301-620X.92B7.23410. PMID: 20595115.

Response 8: We appreciate the reviewer’s thoughtful comments. As this was a retrospective study, we did not collect additional patient-reported outcome measures such as pain intensity scores, cosmetic satisfaction, or passive range of motion data. We acknowledge this as a limitation of our study and recognize the need for further prospective research to address these aspects.

We also agree that the QuickDASH is a valid, reliable, and responsive measure of upper extremity function in adults. Furthermore, previous studies have demonstrated its applicability in younger populations, particularly older children and adolescents. (Quatman-Yates CC et al. Internal consistency and validity of the QuickDASH instrument for upper extremity injuries in older children. J Pediatr Orthop. 2013) Accordingly, many studies have utilized QuickDASH for evaluating upper extremity function in adolescents. (Ahmad CS et al. The Youth Throwing Score: Validating Injury Assessment in Young Baseball Players. Am J Sports Med. 2017)

In response to the reviewer’s suggestion, we have added a statement in the manuscript discussing the limited postoperative outcomes, and recommended that future studies address these important issues. In addition, included references supporting the validity of QuickDASH in adolescent patients.

Revision:

Discussion, Line 290 to 298
Reference, 13

I would like to thank you again for giving me this valuable chance.

Sincerely,

Author Response File: Author Response.pdf

Round 2

Reviewer 1 Report

Comments and Suggestions for Authors

Dear authors, thank you very much for your thorough and thoughtful revision. In my opinion, the manuscript is now complete and suitable for publication in Medicina.

Author Response

Dear authors, thank you very much for your thorough and thoughtful revision. In my opinion, the manuscript is now complete and suitable for publication in Medicina.

Reply: I sincerely thank to you for valuable comments and suggestions during the review process. I hope that our updated submission is now ready to be published in Medicina.

Compared with the initial submission, we have added more than 400 words in the first revision and an additional 600 words in the second revision, thereby enriching the overall content of the manuscript.

We look forward to your favourable response.

Reviewer 3 Report

Comments and Suggestions for Authors

Dear Author

I am honored to have the opportunity to review this study.

Thank you for your accurate replies to each of our comments.　Your research is now more attractive and understandable to readers. Your revised manuscript will be evaluated as worthy of publication.

I would like to thank you again for giving me this valuable chance.

Sincerely,

Author Response

Comments: Dear Author I am honored to have the opportunity to review this study. Thank you for your accurate replies to each of our comments.　Your research is now more attractive and understandable to readers. Your revised manuscript will be evaluated as worthy of publication. I would like to thank you again for giving me this valuable chance. Sincerely, Reply: On behalf of my co-authors, I am pleased to resubmit the second revised version of our manuscript for publication in Medicina. Compared with the initial submission, we have added more than 400 words in the first revision and an additional 600 words in this current second revision, thereby enriching the overall content of the manuscript. I would like to thank you for your helpful comments and suggestions during the review process. I hope that the updated version of our submission is ready to be published in Medicina.