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International Journal of Bioprinting                                      3D-printed PEEK in cranioplasty




            Furthermore, AM technology features several advantages   from the two other materials (i.e., autologous bone and
            in terms of low raw material consumption and cost   titanium mesh) in terms of implant-related complications
            reduction. For clinical application, the AM technique   and the patient’s neurological functions. In addition, FFF-
            is more suitable for fabricating complex anatomical   printed PEEK also has the advantages of good aesthetics,
            structures than the traditional SM technique, especially   low imaging interference, high mechanical performance,
            those in the skull base and maxillofacial junction area. 28,50  and cost-effectiveness. In summary, we believe that FFF-
                                                               printed PEEK implants are an important development
               Previously, a study provided a quantitative assessment
            of the potential clinical efficacy of FFF-printed PEEK   for cranioplasty.
            for cranial reconstruction, validating the safety of AM   Acknowledgments
            technology. 29,51,52  Furthermore, we have previously reported
            the first clinical case of using FFF-printed PEEK implants   The  authors  would  like  to  thank  the patients  who
            for cranial repair.  In the present study, we evaluated the   consented to take part in this study and the doctors in the
                          11
            data of patients with FFF-printed PEEK implants and   participating center who helped to collect the original data.
            compared them with patients with autologous bone and
            titanium mesh. The statistical analyses indicated that there   Funding
            were no significant differences in surgical time, average   This study was supported by the OPEN Project (Grant No.
            postoperative  hospital  stay,  clinical  complications,  and   BHJ17C019),  the  National  Natural  Science  Foundation
            neurological function among the three groups. Based on   of China (82371310, 82271306,81971132, 52125501,
            our findings, we suggest that an FFF-printed prosthesis is   and 51835010), the Young Elite Scientist Sponsorship
            more suitable for patients with large skull defects (strong,   Program  by  the  China  Association  for  Science  and
            artifact-free, and more integrated). Thus, the combination   Technology  (YESS20200178),  the  Sichuan  Science  and
            of an efficient production method (e.g., FFF) with a versatile   Technology Program (2023YFH0069, 2023NSFSC0028,
            material (e.g., PEEK) may produce complex structures   and 2022YFS0615), Scientific research Project of
            (e.g., 3D-PEEK) with great potential and applicability in   Sichuan Provincial Health Commission (23LCYJ040),
            the field of medical and industrial integration. Nonetheless,   Sichuan Provincial Cadre Health Project (ZH2024-
            the present study had several limitations. In comparison to   1501), and the Program for Innovation Team of Shaanxi
            general  clinical  research,  this  single-center  retrospective   Province (2023-CX-TD-17).
            study had a small sample size of 66 cases. Given the rarity
            of the new method (FFF-printed 3D-PEEK skull implant),   Conflict of interest
            the sample  size was considered acceptable.  This study
            also featured a short follow-up time and the inherent   The authors declare no conflicts of interest.
            risk of bias. Additionally, this study did not evaluate the
            differences between AM and SM PEEK implants due to the   Author contributions
            limited number of cases. Therefore, we would suggest to   Conceptualization:  Jianhua  Peng,  Yong  Jiang,  Dichen  Li,
            conduct more and larger sample size multicenter clinical   Jiankang He
            research in the future to further explore the risk factors of   Formal analysis: Hui Zhu, Huanhao Pang
            postoperative complications between FFF-printed PEEK   Investigation: Kuangyang Yu, Yanwen Su, Xiao Rao
            implants,  SM  PEEK  implants, and  other  conventional   Methodology: Huanhao Pang, Changquan Shi, Liang Liu,
            materials. Likewise, we would also suggest conducting a   Yingchao Liu
            longer follow-up on neurological function and appearance   Resources: Jianhua Peng, Yong Jiang, Ligang Chen, Dichen
            after cranial repair to better evaluate the performance of   Li, Jiankang He
            different materials for cranioplasty.              Supervision: Jianhua Peng, Yong Jiang, Jiankang He
                                                               Writing – original draft: Kuangyang Yu, Yanwen Su
            5. Conclusion                                      Writing – review editing: Jianhua Peng, Yong Jiang, Dichen
            Different  materials  have  been  used  in  cranioplasty  over   Li, Jiankang He
            the years. 3D-printed PEEK implants have the advantages   Ethics approval and consent to participate
            of rapid production, low cost, good biocompatibility, and
            ideal mechanical properties. In this study, we evaluated   The protocol was approved by the Ethics Committee and
            the application of FFF-printed PEEK implants in a small-  Research Board of the Affiliated Hospital of Southwest
            scale  clinical  study. Our  findings  revealed that  the  FFF-  Medical University (KY2021133). Consent to participate
            printed PEEK implants were not significantly different   in the study was obtained from the subjects.



            Volume 10 Issue 4 (2024)                       362                                doi: 10.36922/ijb.2583
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