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In an international trial involving 450 patients with acute subdural hematoma, craniotomy (bone flap replaced) and decompressive craniectomy (bone flap left out) yielded similar disability-related outcomes at 12 months.

Patient-specific implant (PSI) has optimized the management for a wide range of complex craniofacial deformity over the past years by increasing the accuracy of surgical procedures and lowering the operating time. In hypertelorism (HTO) surgery particularly, the orbital bone repositioning is nowadays guided by patient-specific bone fixation plates that are usually made from non-resorbable alloplastic material (e.g., titanium). Developing resorbable personalized plates could be a relevant alternative to overcome the well-known drawbacks of titanium plates such as infection, exposure or even the lack of bone growth which is detrimental in pediatric patients. This study investigated the mechanical and structural characteristics of poly(lactic-co-glycolic acid) (PLGA) PSI as resorbable materials for HTO surgery. We assessed the feasibility of printing PLGA PSI by Fused Deposition Modeling additive manufacturing (FDM). The geometrical and the mechanical properties of the 3D-printed device were compared with standard resorbable plates and analyzed after sterilization process (i.e., hydrogen peroxide gas plasma). The Young’s modulus was greater than the standard resorbable plates while a decrease of 36% ( p  = 0.004) after the sterilization was observed. The sterilization also induced a plate deformation with an increase of 0.27 mm in Z-axis and a decrease of 0.8 mm in Y-axis due to annealing effect. Compared to the design, the PLGA PSI were successfully 3D-printed with a maximum deviation of 0.1 mm, making our custom-made plate promising for personalized craniofacial applications. Further investigations on the sterilization process must be considered in view of its mechanical and structural impact on resorbable PSI.

Cranioplasty (CP), a surgical procedure that restores cranial integrity and potentially enhances neurological outcomes, is commonly performed following decompressive craniectomy for various reasons. However, there is considerable controversy and variation regarding the optimal timing for cranioplasty, particularly concerning its impact on neurological functional outcomes. This paper outlines the protocol for a multicenter, non-randomized controlled trial designed to investigate whether the timing of cranioplasty influences neurological outcomes. This study will be conducted from June 2025 to June 2026 across multiple clinical centers in China, targeting the enrollment of at least 500 adults aged 18-65 years with skull defects larger than 25 cm². Participants will be divided based on the timing of their cranioplasty relative to decompressive craniectomy into two groups: early (within 3 months post-decompression) and late (after 3 months). The primary outcome, assessed through the Barthel Index, will measure functional recovery 6 months post-surgery, with secondary outcomes including mortality, quality of life, cognitive performance and complication rates. This non-randomized clinical trial focuses on the neurological outcomes associated with different timings of cranioplasty. It is anticipated that the findings will contribute valuable insights and support more informed clinical decisions regarding the timing of cranioplasty. By comparing early and late cranioplasty, the trial aims to clarify how timing affects recovery and overall neurological improvement post-surgery. Trial Registration: ChiCTR2400094619.

Wig protectors produced via 3D printing were used in skull protection protocols following decompressive craniotomy (DC) surgery. This study is a single-center, prospective trial involving 25 patients who underwent DC. Patients admitted between February 1, 2023, and June 30, 2023, were assigned to the control group (receiving standard care), while those admitted between July 1, 2023, and December 31, 2023, comprised the experimental group (receiving 3D-printed wig protection). The study evaluated participants based on various metrics, including reinjury at the site of the skull defect, daily wear duration, skin indentation, pain levels, itching, discomfort, patient-reported aesthetics, and the Quality of Life (QLQ-C30). They completed both wear assessments and follow-up evaluations at 1, 4, 8, and 12 weeks. Post-intervention, the experimental group exhibited a lower incidence of secondary injuries compared to the control group (0 vs. 3, P  = 0.206). At the three-month follow-up, the experimental group demonstrated better outcomes in self-assessed aesthetics ( P  = 0.025) and QLQ-C30 scores ( P  = 0.041). The 3D-printed wig protector had a weight of 132.3 ± 11.98 g (ranging from 111 to 146 g), and none of the patients in the experimental group reported pain, pressure, itching, or discomfort during the first 30-min wear period. On average, patients wore the device for 2.01 ± 0.22 h in week 1, 5.71 ± 0.40 h in week 4, 6.04 ± 0.10 h in week 8, and 5.93 ± 0.47 h in week 12. While some patients reported minor skin indentation, pain, itching, or a sensation of stuffiness, no serious adverse events were observed.

BACKGROUND:Syndrome of the trephined (SoT) is a rare, important complication of a craniectomy characterized by neurological dysfunction that improves with cranioplasty. Its varied symptoms include motor, cognitive, and language deficits. Its exact characterization appears suboptimal, with differing approaches of evaluation. Accordingly, this topic is in great need of further investigation. OBJECTIVE:To accurately describe SoT and explore methods of an objective diagnosis/evaluation. METHODS:Electronic searches of PubMed, MEDLINE, Web of Knowledge, and PsycINFO databases used the key words “syndrome of the trephined” and “sinking skin flap.” Non–English-language and duplicate articles were eliminated. Title and abstract reviews were selected for relevance. Full-text reviews were selected for articles providing individual characteristics of SoT patients. RESULTS:This review identified that SoT most often occurs in male patients (60%) at 5.1 ± 10.8 months after craniectomy for neurotrauma (38%). The average reported craniectomy is 88.3 ± 34.4 cm and usually exists with a “sunken skin flap” (93%). Symptoms most commonly include motor, cognitive, and language deficits (57%, 41%, 28%, respectively), with improvement after cranioplasty within 3.8 ± 3.9 days. Functional independence with activities of daily living is achieved by 54.9% of patients after 2.9 ± 3.4 months of rehabilitation. However, evaluation of SoT is inconsistent, with only 53% of reports documenting objective studies. DISCUSSION:SoT is a variable phenomenon associated with a prolonged time to cranioplasty. Due to current weaknesses in objectivity, we hypothesize that SoT is often underdiagnosed and recommend a multifaceted approach for consistent evaluation. CONCLUSION:SoT is a serious complication that lacks exact characterization and deserves future investigation. Improved understanding and recognition have important implications for early intervention and patient outcomes. ABBREVIATIONS:ADLs, activities of daily livingCBF, cerebral blood flowSoT, syndrome of the trephinedVP, ventriculoperitoneal

Abstract BACKGROUND Cranioplasty is a ubiquitous neurosurgical procedure consisting of reconstruction of a pre-existing calvarial defect. Many materials are available, including polymethylmethacrylate in hand-moulded (hPMMA) and prefabricated (pPMMA) form, hydroxyapatite (HA), polyetheretherketone (PEEK) and titanium (Ti). OBJECTIVE To perform a network meta-analysis (NMA) to assess the relationship between materials and complications of cranioplasty. METHODS PubMed/MEDLINE, Google Scholar, EMBASE, Scopus, and The Cochrane Library were searched from January 1, 1990 to February 14, 2021. Studies detailing rates of any of infections, implant exposure, or revision surgery were included. A frequentist NMA was performed for each complication. Risk ratios (RRs) with 95% CIs were calculated for each material pair. RESULTS A total of 3620 abstracts were screened and 31 full papers were included. Surgical revision was reported in 18 studies and occurred in 316/2032 cases (14%; 95% CI 11-17). PEEK had the lowest risk of re-operation with a rate of 8/157 (5%; 95% CI 0-11) in 5 studies, superior to autografts (RR 0.20; 95% CI 0.07-0.57), hPMMA (RR 0.20; 95% CI 0.07-0.60), Ti (RR 0.39; 95% CI 0.17-0.92), and pPMMA (RR 0.14; 95% CI 0.04-0.51). Revision rate was 131/684 (19%; 95% CI 13-25; 10 studies) in autografts, 61/317 (18%; 95%CI 9-28; 7 studies) in hPMMA, 84/599 (13%; 95% CI 7-19; 11 studies) in Ti, 7/59 (9%; 95% CI 1-23; 3 studies) in pPMMA, and 25/216 (12%; 95% CI 4-24; 4 studies) in HA. Infection occurred in 463/4667 (8%; 95% CI 6-11) and implant exposure in 120/1651 (6%; 95% CI 4-9). CONCLUSION PEEK appears to have the lowest risk of cranioplasty revision, but further research is required to determine the optimal material. Graphical Abstract Graphical Abstract

Chronic cranial window (CCW) is an essential tool in enabling longitudinal imaging and manipulation of various brain activities in live animals. However, an active CCW capable of sensing the concealed in vivo environment while simultaneously providing longitudinal optical access to the brain is not currently available. Here we report a disposable ultrasound-sensing CCW (usCCW) featuring an integrated transparent nanophotonic ultrasonic detector fabricated using soft nanoimprint lithography process. We optimize the sensor design and the associated fabrication process to significantly improve detection sensitivity and reliability, which are critical for the intend longitudinal in vivo investigations. Surgically implanting the usCCW on the skull creates a self-contained environment, maintaining optical access while eliminating the need for external ultrasound coupling medium for photoacoustic imaging. Using this usCCW, we demonstrate photoacoustic microscopy of cortical vascular network in live mice over 28 days. This work establishes the foundation for integrating photoacoustic imaging with modern brain research. Chronic cranial windows (CCW) enable long-term imaging of brain activity, but usually they only provide passive optical access to the tissue. Here the authors develop an active CCW integrated with an ultrasound detector which enables long-term photoacoustic imaging of the cortical vasculature in live mice with higher image quality.

Abstract BACKGROUND: Cranioplasty after decompressive craniectomy (DC) is routinely performed for reconstructive purposes and has been recently linked to improved cerebral blood flow (CBF) and neurological function. OBJECTIVE: To systematically review all available literature to evaluate the effect of cranioplasty on CBF and neurocognitive recovery. METHODS: A PubMed, Google Scholar, and MEDLINE search adhering to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines included studies reporting patients who underwent DC and subsequent cranioplasty in whom cerebral hemodynamics were measured before and after cranioplasty. RESULTS: The search yielded 21 articles with a total of 205 patients (range 3–76 years) who underwent DC and subsequent cranioplasty. Two studies enrolled 29 control subjects for a total of 234 subjects. Studies used different imaging modalities, including CT perfusion (n = 10), Xenon-CT (n = 3), single-photon emission CT (n = 2), transcranial Doppler (n = 6), MR perfusion (n = 1), and positron emission tomography (n = 2). Precranioplasty CBF evaluation ranged from 2 days to 6 months; postcranioplasty CBF evaluation ranged from 7 days to 6 months. All studies demonstrated an increase in CBF ipsilateral to the side of the cranioplasty. Nine of 21 studies also reported an increase in CBF on the contralateral side. Neurological function improved in an overwhelming majority of patients after cranioplasty. CONCLUSION: This systematic review suggests that cranioplasty improves CBF following DC with a concurrent improvement in neurological function. The causative impact of CBF on neurological function, however, requires further study.

Background OptimalTTF-2 is a randomized, comparative, multi-center, investigator-initiated, interventional study aiming to test skull remodeling surgery in combination with Tumor Treating Fields therapy (TTFields) and best physicians choice medical oncological therapy for first recurrence in glioblastoma patients. OptimalTTF-2 is a phase 2 trial initiated in November 2020. Skull remodeling surgery consists of five burrholes, each 15 mm in diameter, directly over the tumor resection cavity. Preclinical research indicates that this procedure enhances the effect of Tumor Treating Fields considerably. We recently concluded a phase 1 safety/feasibility trial that indicated improved overall survival and no additional toxicity. This phase 2 trial aims to validate the efficacy of the proposed intervention. Methods The trial is designed as a comparative, 1:1 randomized, minimax two-stage phase 2 with an expected 70 patients to a maximum sample size of 84 patients. After 12-months follow-up of the first 52 patients, an interim futility analysis will be performed. The two trial arms will consist of either a) TTFields therapy combined with best physicians choice oncological treatment (control arm) or b) skull remodeling surgery, TTFields therapy and best practice oncology (interventional arm). Major eligibility criteria include age ≥ 18 years, 1st recurrence of supratentorial glioblastoma, Karnofsky performance score ≥ 70, focal tumor, and lack of significant co-morbidity. Study design aims to detect a 20% increase in overall survival after 12 months (OS12), assuming OS12 = 40% in the control group and OS12 = 60% in the intervention group. Secondary endpoints include hazard rate ratio of overall survival and progression-free survival, objective tumor response rate, quality of life, KPS, steroid dose, and toxicity. Toxicity, objective tumor response rate, and QoL will be assessed every 3rd month. Endpoint data will be collected at the end of the trial, including the occurrence of suspected unexpected serious adverse reactions (SUSARs), unacceptable serious adverse events (SAEs), withdrawal of consent, or loss-to-follow-up. Discussion New treatment modalities are highly needed for first recurrence glioblastoma. Our proposed treatment modality of skull remodeling surgery, Tumor Treating Fields, and best practice medical oncological therapy may increase overall survival significantly. Trial registration ClinicalTrials.gov Identifier: NCT0422399 , registered 13. January 2020.