Preoperative planning of craniectomy and reconstruction using three-dimension-printed cranioplasty for treatment of calvarial lesion.

Background: Common calvarial lesions include fibrous dysplasia (FD), intraosseous meningioma, osteoma, Langerhans cell histiocytosis (LCH), intraosseous hemangioma, dermoid and epidermoid cyst, and malignancy. Surgical removal with removal of the involved skull is the choice of treatment for these lesions. Previously, the skull defect was repaired using allograft, and alloplastic materials have been replaced with newer polyetheretherketone (PEEK) material, which is more resistant, biocompatible, and can be 3-dimension (3D)--printed. High-resolution 3D printing uses very fine extruders to put materials in fine layers to recreate patients' anatomy authentically, which gives superior cosmetic outcomes. Our objectives were preoperative planning of craniectomy and reconstruction for calvarial lesions and reconstruction of skull defects using 3D-printed cranioplasty with PEEK materials. Methods: In this series, we describe 11 cases in which skull lesions were removed and reconstructed in the same sitting using a 3D-printed PEEK implant designed preoperatively using high-resolution computer tomography. All the cases were done in the neurosurgery department of Bangabandhu Sheikh Mujib Medical University from 2021 to 2023. Patients were followed up for 6 months after surgery. Results: Regarding 11 cases, six cases were FD, three cases were intraosseous meningioma, one case was intraosseous hemangioma, and one case was LCH. Average lesion size were 12.73-5.77 cm. Cranioplasty was done with PEEK material. Minor complications were treated conservatively. Seroma, postoperative fever, and nausea were among these. Conclusion: The human bone-like biocompatibility and resistance to physical forces leads to more frequent use of PEEK, which enables to repair of complex craniofacial defects with better cosmesis. Despite some limitations, the PEEK cranioplasty implant continued to thrive and showed its promise to be an excellent material. Further, research and investment should be put into developing the technique.

Manufacturing Process of Prostheses Using Semirigid Molds by Additive Technologies.

Prostheses play a vital role in restoring function and mobility to individuals with physical disabilities. This study focuses on the procedure to create customized prostheses using semirigid molds obtained from additive technologies. This innovative methodology aims to improve the fit and comfort of prostheses.The manufacturing process of prostheses using semirigid molds combined with additive technologies involves several key phases. These include the use of computed tomography (CT) of the affected area, computer-aided design, and the production of custom mold models.This study introduces the main production phases of customized prostheses, based on the strategy that involves the manufacturing of semirigid molds, by additive manufacturing (AM). This approach improves fit, comfort, and integration of prostheses into patients' daily lives. In particular, prostheses for cranioplasty are described in this study.

Neurocognitive outcome post cranioplasty: The role of cerebral hemodynamics and cerebrospinal fluid dynamics.

Background: Cranioplasty has been useful in treating the symptoms associated with the "Sunken skin flap syndrome" post decompressive craniectomy, for which various mechanisms have been proposed. In this study, we aim to assess the changes in the cerebral blood flow and intracranial cerebrospinal fluid (CSF) dynamics post cranioplasty and correlate with the improvement in the neurocognitive status. Methods: Computed tomography perfusion and cine magnetic resonance imaging studies were done to study the changes in cerebral perfusion and CSF flow dynamics postcranioplasty. The cognitive status was assessed using Montreal cognitive assessment, mini-mental state examination, and frontal assessment battery scores in the preoperative period and at 1 and 6 months follow-up. Results: There was a significant change in cognitive status postcranioplasty, both at 1 and 6 months follow-up, which was associated with a significant improvement in cerebral blood flow, decreased mean transit time, and improvement in the mean and peak CSF flow velocities at the foramen of Magendie and aqueduct of Sylvius. Conclusion: Cranioplasty leads to a marked improvement in cerebral hemodynamics, which is more significant on the ipsilateral side. It also leads to increased CSF turnover and improved CSF circulation. Improved cerebral perfusion and, more importantly, CSF dynamics may be responsible for the demonstrable improvement in the neurocognition in the postcranioplasty period.

Bone Regeneration and Polyetheretherketone Implants in Maxillo-Facial Surgery and Neurosurgery: A Multidisciplinary Study.

Polyetheretherketone (PEEK) in the last few years has emerged as an exceedingly promising material for craniofacial defects due to its biocompatibility and mechanical properties. However, its utilization remains controversial due to its inertness and low osteoinductivity. This study aimed to investigate the postoperative outcomes of patients undergoing maxillo-facial and neurosurgical procedures with PEEK implants. The focus is on evaluating bone regrowth on the surface and edges of the implant, periosteal reactions, and implant positioning. A retrospective analysis of 12 maxillo-facial surgery patients and 10 neurosurgery patients who received PEEK implants was conducted. CT scans performed at least one year post operation were examined for bone regrowth, periosteal reactions, and implant positioning. In maxillo-facial cases, the analysis included mandibular angle and fronto-orbital reconstruction, while neurosurgical cases involved cranioplasty. In maxillofacial surgery, 11 out of 12 patients showed radiological evidence of bone regrowth around PEEK implants, with favorable outcomes observed in craniofacial reconstruction. In neurosurgery, 9 out of 10 patients exhibited minimal or none bone regrowth, while one case demonstrated notable bone regeneration beneath the PEEK implant interface. The study highlights the importance of implant design and patient-specific factors in achieving successful outcomes, providing valuable insights for future implant-based procedures.

Early Challenges in the Implementation of Automated CranialRebuild Freeware for Generation of Patient-Specific Cranial Implant Using Additive Manufacturing: A Pilot Project in Review.

Traumatic Brain Injury (TBI) is a significant global health concern, particularly in low- and middle-income countries (LMICs) where access to medical resources is limited. Decompressive craniectomy (DHC) is a common procedure to alleviate elevated intracranial pressure (ICP) following TBI, but the cost of subsequent cranioplasty can be prohibitive, especially in resource-constrained settings. We describe challenges encountered during the beta-testing phase of CranialRebuild 1.0, an automated software program tasked with creating patient-specific cranial implants (PSCIs) from CT images. Two pilot clinical teams in the Philippines and Ukraine tested the software, providing feedback on its functionality and challenges encountered. The constructive feedback from the Philippine and Ukrainian teams highlighted challenges related to CT scan parameters, DICOM file arrays, software limitations, and the need for further software improvements. CranialRebuild 1.0 shows promise in addressing the need for affordable PSCIs in LMICs. Challenges and improvement suggestions identified throughout the beta-testing phase will shape the development of CranialRebuild 2.0, with the aim of enhancing its functionality and usability. Further research is needed to validate the software's efficacy in a clinical setting and assess its cost-effectiveness.

Safety and efficacy of antibiotic-impregnated absorbable calcium sulfate beads (Stimulan) in cranioplasty.

Cranioplasty is a common neurosurgical procedure that follows hemicraniectomy in the setting of neoplasm resection or increased intracranial pressure. Although standardized practices aim at minimizing infection risk, infection of the surgical site has been reported in 6.6%-8.4% of patients. In this work, we document the novel use of synthetic dissolvable antibiotic-impregnated calcium sulfate beads (STIMULANⓇ Rapid Cure, Biocomposites Ltd, Wilmington, NC, USA) in five cases of cranioplasty at our institution. Four patients experienced wound healing as expected with no complications related to the use of Stimulan beads. One patient's clinical course was complicated by pseudomeningocele with superficial wound infection occurring 74 days following cranioplasty. Of note, this patient had suffered an avulsion injury and subgaleal hematoma of the scalp ipsilateral to the cranial incision, predisposing to infection due to incompetent scalp vasculature. No complications could be directly attributed to the use of STIMULANⓇ beads.

Metastasectomy for extracalvarial renal cell carcinoma.

Key Clinical Message: Palliative surgical resection of extra-calvarial metastatic lesions from renal cell tumors is crucial for controlling metastatic spread, improving quality of life, and preventing associated morbidity. Careful surgical planning, including selective preoperative embolization and controlled resection around critical structures such as the sagittal sinus, is essential for successful outcomes. Cranioplasty with Titanium mesh and bone cement post-resection can provide symptomatic relief, better cosmesis, and overall improved quality of life. Abstract: Renal cell carcinomas are aggressive tumors with distant systemic disease. The calvarium appears to be an unusual and rare site for distant metastasis. The treatment modalities are challenging and out of the normal realm for the management of these tumors. We report a case of a 63-year-old woman with a previous history of nephrectomy who presented with symptoms of severe headaches, and swelling of bi-frontal and bi-parietal scalp regions due to multifocal extracalvarial disease. Preoperative bilateral superficial temporal artery embolization was performed to control the intraoperative bleeding. Surgical technique has been described with the critical steps involved, and a literature review has been conducted. Palliative tumor resection surgery was performed to improve the patient's quality of life as well as to confirm the histopathological diagnosis. Gross total resection of the extracalvarial metastatic tumor was achieved. Biopsy confirmed renal cell tumor with the clear cell subtype. The patient recovered well from her surgery with slow healing of the scalp wound. At 6-month follow-up, no recurrence of the extracalvarial disease was observed on serial imaging. Extracalvarial metastasis is a rare presentation in renal cell carcinoma. Considering the inherent radioresistant nature of the tumor, palliative surgical resection can be offered to control the metastatic spread, relieve agonizing pain symptoms, and to improve the quality of life. Preoperative embolization helps to decrease intraoperative blood loss. Moreover, palliative surgical resection of extracalvarial diseases helps to treat the metastasis as well as avoiding the associated morbidity that may occur if left untreated.

Predictive factors influencing outcome of early cranioplasty after decompressive craniectomy: a outcome prediction model study.

Objective: The timing of cranioplasty (CP) has become a widely debated topic in research, there is currently no unified standard. To this end, we established a outcome prediction model to explore the factors influencing the outcome of early CP. Our aim is to provide theoretical and practical basis for whether patients with skull defects after decompressive craniectomy (DC) are suitable for early CP. Methods: A total of 90 patients with early CP after DC from January 2020 to December 2021 were retrospectively collected as the training group, and another 52 patients with early CP after DC from January 2022 to March 2023 were collected as the validation group. The Nomogram was established to explore the predictive factors that affect the outcome of early CP by Least absolute shrinkage analysis and selection operator (LASSO) regression and Logistic regression analysis. Receiver operating characteristic (ROC) curve was used to evaluate the discrimination of the prediction model. Calibration curve was used to evaluate the accuracy of data fitting, and decision curve analysis (DCA) diagram was used to evaluate the benefit of using the model. Results: Age, preoperative GCS, preoperative NIHSS, defect area, and interval time from DC to CP were the predictors of the risk prediction model of early CP in patients with skull defects. The area under ROC curve (AUC) of the training group was 0.924 (95%CI: 0.867-0.980), and the AUC of the validation group was 0.918 (95%CI, 0.842-0.993). Hosmer-Lemeshow fit test showed that the mean absolute error was small, and the fit degree was good. The probability threshold of decision risk curve was wide and had practical value. Conclusion: The prediction model that considers the age, preoperative GCS, preoperative NIHSS, defect area, and interval time from DC has good predictive ability.

Reduction cranioplasty for hydrocephalic macrocephaly: a systematic review of surgical outcomes.

OBJECTIVE: Hydrocephalic macrocephaly can result in poor psychosocial development, positioning difficulties, skin breakdown, and poor cosmesis. Although reduction cranioplasty can address these sequelae, the postoperative outcomes, complications, and mortality risk of reduction cranioplasty are not well understood given the rarity of hydrocephalic macrocephaly. Therefore, the primary objective of this systematic review was to evaluate the surgical outcomes of reduction cranioplasty for the treatment of hydrocephalic macrocephaly. METHODS: A systematic review was performed using the PubMed, Scopus, and Web of Science databases while following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Two independent reviewers screened 350 studies; 27 studies reporting surgical outcomes on reduction cranioplasty for hydrocephalic macrocephaly met inclusion criteria. Data on study design, patient demographics, operative details, and surgical outcomes were collected. RESULTS: There were 65 reduction cranioplasties among the 27 included studies. Eighteen (66.7%) studies presented level V evidence, 7 (25.9%) presented level IV evidence, and 2 (7.4%) presented level III evidence. Following reduction cranioplasty, there was improvement in postoperative head positioning in 23 (85.2%) studies, improvement in postoperative cosmesis in 22 (81.5%) studies, and improvement in global postoperative neurological functioning in 20 (74.1%) studies. The median estimated blood loss was 633 mL (range 20-2600 mL). Shunt revisions were the most common complication, reported in 9 (47.4%) of the 19 studies assessing complications. Of the 65 patients, there was a mortality rate of 6.2% (n = 4). CONCLUSIONS: The majority of the included studies reported improvement in head size, head positioning, cranial cosmesis, and global neurological functioning following reduction cranioplasty for hydrocephalic macrocephaly. However, the prevalence of lower-level evidence, risk of blood loss, complications, and mortality indicates the need for a serious discussion of surgical indication, an experienced team, and thorough perioperative planning to perform these complex surgeries.

Estimation of Titanium Levels in Blood Following Reconstruction of Post-Craniotomy Defect by Titanium Mesh Using Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES).

Introduction: Titanium and its alloys are the most popular choice of materials for the reconstruction of craniofacial defects. They have lighter weight and are nonferromagnetic, which makes them an advantage in cranial defect reconstruction. Although the formed oxide layer makes them corrosion-resistant, levels of titanium in blood have been seen in trace amounts. This is the first study as per authors' knowledge that a study of such kind has been conducted. Materials and methods: A pilot study was carried out at a tertiary level hospital, considering the inclusion and exclusion criteria in patients who were planned for the reconstruction of the residual defect using titanium mesh. Preoperative and 03- and 06-months postoperative blood samples were collected and analyzed for estimating the levels of titanium ions in blood by inductively coupled plasma-optical emission spectroscopy (ICP-OES). Results: Friedman's two-way analysis of variance by ranks was considered for testing of hypothesis summary, owing to the smaller sample size. The analysis suggested an increase in levels was minimal. Considering the asymptotic significances (two-tailed significance), a significance level was 0.050, which directed us to reject the null hypothesis. Pairwise comparison suggested the presence of negative values indicating steady increase in levels. Cluster analysis indicated that although minimal there is a cluster of difference in the values at all three stages. Continuous field information was used to determine the level with regard to the level of titanium at the three stages of study. Conclusion: The study revealed that the levels of titanium ions increase on prolonged contact with living tissues. The trace elements have to be analyzed at regular intervals. This first-of-the-time study if extended to larger sample size would reveal interesting facts.

Cryopreserved bone flaps from decompressive craniectomies: a microbiological analysis.

PURPOSE: Surgical site infection (SSI) is a serious complication after cranioplasty. Due to the relatively frequent occurrence of post-cranioplasty SSI, the utility of autologous bone flap swab cultures surrounding cryopreservation as a reliable predictor has been the subject of an ongoing debate. This bicentric study aims to contribute to this topic by conducting an in-depth analysis of bone flaps obtained via decompressive craniectomies. This study had three major aims: assessments of 1) bacterial contamination of bone flaps after decompressive craniotomy, 2) impact of cryoconservation on contamination rates and 3) potential effectiveness of anti-infective treatment to reduce the germ load prior to cranioplasty. METHODS: Cryopreserved bone flaps from two centers were used. Microbiological cultivations of swabs prior to and after cryopreservation were taken and assessed for aerobic and anaerobic growth over a 14-day incubation period. Additionally, in a subset of bone flaps, swab testing was repeated after thorough rinsing with an anti-infectant (octenidine-phenoxyethanol) followed by saline. RESULTS: All 63 bone flaps (patients median age at surgery: 59 years) were obtained via decompressive craniectomies. Swabs done prior to cryopreservation revealed a 54% infection rate with Propionibacterium acnes being the most common microorganism in 65% of those cases. After thorough disinfection of the preserved bone flaps, all but one case showed no bacterial growth in swab testing. Furthermore, no relevant risk factors for bacterial contamination could be identified. CONCLUSION: This retrospective study showed the common presence of bacterial growth in cryopreserved bone flaps before and after freezing. Rinsing with octenidine-phenoxyethanol and saline effectively prevented bacterial growth in a notable percentage of cases, suggesting a potential strategy to reduce contamination. However, persistent bacterial growth in some cases underscores the need for further research to optimize antiseptic measures during autologous cranioplasty.

Conceptual Principles in Pediatric Craniomaxillofacial Reconstruction.

Pediatric craniomaxillofacial reconstruction must be approached through the lens of growth and durability. A systematic approach of matching defects to donor tissue drives the selection of autologous reconstructive technique. The menu of available methods for reconstruction can be organized in a manner similar to adults, with special considerations for growth and development. Reconstructive surgeons have the opprtunity to promote and maintain young patients' sense of identity during psychosocial development.

Appropriate Use of Preoperative Imaging in Feminization Cranioplasty.

Study Design: Retrospective chart review. Objective: The objective of this study was to determine if proceeding with feminization frontal cranioplasty without preoperative imaging adversely affected patient outcomes. Methods: This study retrospectively reviewed all patients undergoing frontal cranioplasty for facial feminization at a single tertiary care center between 2013 and 2019. All procedures were performed by a single surgeon (JS), who operated at multiple sites. The site selected is where the majority of these procedures were performed during this time. Type of cranioplasty (I vs III) was recorded. Primary outcomes included postoperative cerebrospinal fluid (CSF) leak, entering the cranium, or dural exposure or injury. Results: 422 subjects underwent cranioplasty for facial feminization between 2013 and 2019. No preoperative imaging was performed. Zero patients had CSF leak. 334 subjects (79%) had type III cranioplasty, while the remaining 88 subjects (21%) had type I cranioplasty. No subjects had documented episodes of dural injury, or postoperative brain or cranial concerns. Conclusions: This study demonstrates that frontal cranioplasty for facial feminization does not require routine preoperative imaging. The authors recommend preoperative imaging for patients with a history of congenital cranial abnormality, prior significant head trauma affecting the frontal bone, and in some cases where the patient has had prior surgery or a history of sinus disease or extensive polyposis. Routine preoperative computed tomography is therefore not indicated for patients undergoing feminizing cranioplasty.

Objective Photoanalysis of Feminizing Frontal Cranioplasty Outcomes.

Study Design: Retrospective analysis at a tertiary care center. Objective: This study describes a method of analyzing postoperative results using lateral view clinical photographs to create normalized projection ratios of the glabella and radix. Methods: We reviewed preoperative and postoperative photographs of 15 patients. All photographs were in the lateral view Frankfort horizontal plane. We calculated the distances between the (a) tragus and cornea, (b) cornea and radix, (c) cornea and glabella, and the (θ) nasofrontal angle. Results: Fifteen sets of patient photographs were analyzed and found that there was a favorable 14% reduction at the radix and an even greater reduction (78.9%) at the glabella. The nasofrontal angle was improved to a more feminine range from 131.84° preoperatively to 145.86° postoperatively. Conclusions: Normalized projection ratios of the glabella and radix, along with the nasofrontal angle, can be used to objectively measure outcomes of frontal feminizing cranioplasty.

Resorbable Patient-Specific Implants of Molybdenum for Pediatric Craniofacial Surgery-Proof of Concept in an In Vivo Pilot Study.

Titanium continues to be the gold standard in the field of osteosynthesis materials. This also applies to pediatric craniofacial surgery. Various resorbable materials have already been developed in order to avoid costly and risky second operations to remove metal in children. However, none of these resorbable materials have been able to completely replace the previous gold standard, titanium, in a satisfactory manner. This has led to the need for a new resorbable osteosynthesis material that fulfills the requirements for biocompatibility, stability, and uniform resorption. In our previous in vitro and in vivo work, we were able to show that molybdenum fulfills these requirements. To further confirm these results, we conducted a proof of concept in four domestic pigs, each of which was implanted with a resorbable molybdenum implant. The animals were then examined daily for local inflammatory parameters. After 54 days, the animals were euthanized with subsequent computer tomography imaging. We also removed the implants together with the surrounding tissue and parts of the spleen, liver, and kidney for histopathological evaluation. The molybdenum implants were also analyzed metallographically and using scanning electron microscopy. A blood sample was taken pre- and post-operatively. None of the animals showed clinical signs of inflammation over the entire test period. Histopathologically, good tissue compatibility was found. Early signs of degradation were observed after 54 days, which were not sufficient for major resorption. Resorption is expected with longer in situ residence times based on results of similar earlier investigations.

Back to the Roots: Reconstructing Large and Complex Cranial Defects using an Image-based Statistical Shape Model.

Designing implants for large and complex cranial defects is a challenging task, even for professional designers. Current efforts on automating the design process focused mainly on convolutional neural networks (CNN), which have produced state-of-the-art results on reconstructing synthetic defects. However, existing CNN-based methods have been difficult to translate to clinical practice in cranioplasty, as their performance on large and complex cranial defects remains unsatisfactory. In this paper, we present a statistical shape model (SSM) built directly on the segmentation masks of the skulls represented as binary voxel occupancy grids and evaluate it on several cranial implant design datasets. Results show that, while CNN-based approaches outperform the SSM on synthetic defects, they are inferior to SSM when it comes to large, complex and real-world defects. Experienced neurosurgeons evaluate the implants generated by the SSM to be feasible for clinical use after minor manual corrections. Datasets and the SSM model are publicly available at https://github.com/Jianningli/ssm .

Pitching for the hitch: Neodural tenting sutures to prevent post-cranioplasty collection in a sunken craniectomy site.

Post-operative epidural collection is a commonly encountered complication following cranioplasty (CP) in a patient with a sunken skin flap. While on most occasions, the collection is small and resolves spontaneously, on occasion, it may be large enough to warrant evacuation. Further, such collections may predispose to infection and bone flap resorption. Dural hitch sutures were once used routinely in all craniotomies by tacking up the dura at the margins of the craniotomy to the surrounding pericranium to prevent post-operative epidural collection but now several surgeons use them only when deemed absolutely necessary. We describe a variation (in cases where CP is performed in patients with a sunken flap) where several sutures are passed from the neodura through the center of the bone flap (as opposed to the peripherally placed conventional hitch sutures) to obviate the dead space and prevent any post-operative collection.

Cranial Repair in Children: Techniques, Materials, and Peculiar Issues.

Cranial repair in children deserves particular attention since many issues are still controversial. Furthermore, literature data offer a confused picture of outcome of cranioplasty, in terms of results and complication rates, with studies showing inadequate follow-up and including populations that are not homogeneous by age of the patients, etiology, and size of the bone defect.Indeed, age has merged in the last years as a risk factor for resorption of autologous bone flap that is still the most frequent complication in cranial repair after decompressive craniectomy.Age-related factors play a role also when alloplastic materials are used. In fact, the implantation of alloplastic materials is limited by skull growth under 7 years of age and is contraindicated in the first years if life. Thus, the absence of an ideal material for cranioplasty is even more evident in children with a steady risk of complications through the entire life of the patient that is usually much longer than surgical follow-up.As a result, specific techniques should be adopted according to the age of the patient and etiology of the defect, aiming to repair the skull and respect its residual growth.Thus, autologous bone still represents the best option for cranial repair, though limitations exist. As an alternative, biomimetic materials should ideally warrant the possibility to overcome the limits of other inert alloplastic materials by favoring osteointegration or osteoinduction or both.On these grounds, this paper aims to offer a thorough overview of techniques, materials, and peculiar issues of cranial repair in children.

Double Skull Sign After Cranioplasty: A Case Report.

The double skull sign (DSS) is a unique image on the outside of the brain that looks like two skulls. Whereas congenital and acquired types of DSS have been reported, the etiology of both of them is calcified hematomas. We encountered a case of a 46-year-old woman with a history of subarachnoid hemorrhage followed by cranioplasty at 43 years old. She developed right hemiparalysis and motor aphasia suddenly. Brain computed tomography and magnetic resonance imaging revealed not only cerebral infarction but also DSS incidentally. After detailed analysis, we concluded that the DSS in this case was not due to calcification of the hematoma but was related to the cranioplasty. In this report, we present an interesting case and discuss etiologies of the development of DSS after cranioplasty.

A comprehensive bench-to-bed look into the application of gamma-sterilized 3D-printed polycaprolactone/hydroxyapatite implants for craniomaxillofacial defects, an in vitro, in vivo, and clinical study.

This study investigates the safety and efficacy of 3D-printed polycaprolactone/hydroxyapatite (PCL/HA) scaffolds for patient-specific cranioplasty surgeries, employing liquid deposition modeling (LDM) technology. This research is pioneering as it explores the impact of gamma radiation on PCL/HA scaffolds and utilizes printing ink with the highest content of HA known in the composite. The mechanical, morphological, and macromolecular stability of the gamma-sterilized scaffolds were verified before implantation. Subsequent research involving animal subjects was conducted to explore the effects of sterilized implants. Eventually, three clinical cases were selected for the implantation studies as part of a phase 1 non-randomized open-label clinical trial. It was shown that a 25 kGy gamma-ray dose for sterilizing the printed implants did not alter the required geometrical precision of the printed implants. The implants exhibited well-distributed HA and strength comparable to cancellous bone. Gamma radiation reduced hydrophobicity and water uptake capacity without inducing pyrogenic or inflammatory responses. Personalized PCL/HA substitutes successfully treated various craniomaxillofacial defects, including trauma-induced facial asymmetry and congenital deformities. HA nanoparticles in the ink stimulated significant osteoconductive responses within three months of implantation. Moreover, the results revealed that while larger implants may exhibit a slower bone formation response in comparison to smaller implants, they generally had an acceptable rate and volume of bone formation. This clinical trial suggests the application of a sterilized PCL/HA composite for craniomaxillofacial surgery is safe and could be considered as a substitute for autologous bone.