Clinical Outcomes of 3D-Printed Bioresorbable Scaffolds for Bone Tissue Engineering—A Pilot Study on 126 Patients for Burrhole Covers in Subdural Hematoma
, John J. Y. Zhang 2, Mervyn J. R. Lim 2, Chun Peng Goh 2, Nivedh Dinesh 2, Srujana V. Vedicherla 2, Ming Yang 3, Kejia Teo 2, Tseng Tsai Yeo 2 and Vincent D. W. Nga 2,*Round 1
Reviewer 1 Report
The paper reports the results of a cross-sectional study of a burr hole cover device named Osteoplug. At the time of implantation, the device had already received FDA approval for human clinical use. The study has been approved by the Domain Specific Review Board (National Healthcare Group).
The article provides a fairly comprehensive description of the study design, including inclusion and exclusion criteria, primary and secondary outcomes with the variables to be measured and the scales used for these measures.
The results are clearly reported.
There are undoubtedly many limitations to the presented study, mainly concerning small amount of the patients included, the low standardization of the data, and the procedures by which the interviews were conducted. All these limitations were discussed in the paper honestly and fully, but it would be necessary to better clarify the rationale for the choice of the scales used to assess the outcomes and in what way and why these scales were changed (as stated in line 210).
In addition, authors could deepen and expand the comparison between the considered device and existing alternatives.
The section line in Figure 1B should be corrected.
Author Response
Please see the attachment.
Author Response File: 
Author Response.docx
Reviewer 2 Report
The authors provide a study based on a redesign of a polycaprolactone burrhole cover for placement of subdural drains, and observed to good cosmetic outcomes and comparable safety outcomes. Implant use was not associated with increased complications. The authors found this PCL cover to have the potential to reduce scalp depression related cosmetic handicaps in chronic subdural hematoma patients.
Overall, the quality of the methodology and analysis are well done. I have only minor comments:
- The authors should reorganize and structure their methodology according to the STROBE (STrengthening the Reporting of OBservational studies in Epidemiology)
- The authors should shorten the overall content of the manuscript significantly. There is extensive information in the introduction and discussion, and the result section can be shortened as well
- Results should not be reported in the text when tables do show the same numbers
Author Response
Please see the attachment.
Author Response File: Author Response.docx
