Decompressive craniectomy (DC) is a surgical procedure where a portion of the skull is removed to relieve potentially fatal brain swelling. As the swelling can take months to subside, the patient is discharged from an acute care facility to recover prior to cranioplasty (reconstruction surgery). Cranioplasty is associated with complications due to infection, seizure, haematoma and death. The interval between these surgeries is potentially a modifiable risk factor to reduce the rate of complication. We aim to allow clinicians to remotely monitor patients to facilitate an optimal pre-operative review. We have developed a platform technology encompassing a 'smart' device fitted into a skullcap to measure physiological parameters, such as changes in brain swelling, and a clinician portal that allows remote viewing of the patients' physiological data. The use of patient generated data during the transition between craniectomy and cranioplasty has the potential to significantly improve neurorehabilitation outcomes for patients.

Additive manufacturing technologies have enabled the development of customised implants for craniomaxillofacial applications using biomaterials such as polymethylmethacrylate (PMMA), porous high-density polyethylene (pHDPE), and titanium mesh. This study aims to report an Australian manufacturer's experience in developing, designing and supplying patient-specific craniomaxillofacial implants over 23 years and summarise feedback received from clinicians. The authors conducted a retrospective review of the manufacturer's implant database of orders placed for custom craniomaxillofacial implants between 1996 and 2019. The variables collected included material, country of order, gender, patient age, and reported complications, which included a measure of custom implant “fit” and adverse events. The development of critical checkpoints in the custom manufacturing process that minimise clinical or logistical non-conformities is highlighted and discussed. A total of 4120 patient-specific implants were supplied, of which 2689 were manufactured from PMMA, 885 from titanium mesh, and 546 from pHDPE. The majority of the implants were used in Australia (2260), United Kingdom (412), Germany (377), and New Zealand (338). PMMA was the preferred material for cranial implants whereas pHDPE was preferred for maxillofacial applications. Age or gender did not influence the material choice. Implant “fit” and adverse outcomes were used as a metric of implant performance. Between 2007 and 2019 there were 37 infections (0.98%) and 164 non-conformities recorded of which 75 (1.8%) were related to implant ‘fit’. Our experience demonstrates a safe, reliable, and clinically streamlined manufacturing process which supports surgeons that require bespoke craniomaxillofacial solutions for reconstruction surgery.

Additive manufacturing technologies have enabled the development of customised implants for craniomaxillofacial applications using biomaterials such as polymethylmethacrylate (PMMA), porous high-density polyethylene (pHDPE), and titanium mesh. This study aims to report an Australian manufacturer's experience in developing, designing and supplying patient-specific craniomaxillofacial implants over 23 years and summarise feedback received from clinicians. The authors conducted a retrospective review of the manufacturer's implant database of orders placed for custom craniomaxillofacial implants between 1996 and 2019. The variables collected included material, country of order, gender, patient age, and reported complications, which included a measure of custom implant "fit" and adverse events. The development of critical checkpoints in the custom manufacturing process that minimise clinical or logistical non-conformities is highlighted and discussed. A total of 4120 patient-specific implants were supplied, of which 2689 were manufactured from PMMA, 885 from titanium mesh, and 546 from pHDPE. The majority of the implants were used in Australia (2260), United Kingdom (412), Germany (377), and New Zealand (338). PMMA was the preferred material for cranial implants whereas pHDPE was preferred for maxillofacial applications. Age or gender did not influence the material choice. Implant "fit" and adverse outcomes were used as a metric of implant performance. Between 2007 and 2019 there were 37 infections (0.98%) and 164 non-conformities recorded of which 75 (1.8%) were related to implant 'fit'. Our experience demonstrates a safe, reliable, and clinically streamlined manufacturing process which supports surgeons that require bespoke craniomaxillofacial solutions for reconstruction surgery.

Pre-surgical planning using 3D-printed BioModels enables the preparation of a "patient-specific" kit to assist instrumented spinal fusion surgery. This approach has the potential to decrease operating time while also offering logistical benefits and cost savings for healthcare. We report our experience with this method in 129 consecutive patients undergoing minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) over 27 months at a single centre and performed by a single surgeon. Patient imaging and surgical planning software were used to manufacture a 3D-printed patient-specific MIS TLIF kit for each patient consisting of a 1:1 scale spine BioModel, stereotactic K-wire guide, osteotomy guide, and retractors. Pre-selected pedicle screws, rods, and cages were sourced and supplied with the patient-specific kit. Additional implants were available on-shelf to address a size discrepancy between the kit implant and intraoperative measurements. Each BioModel was used pre-operatively for surgical planning, patient consent and education. The BioModel was sterilised for intraoperative reference and navigation purposes. Efficiency measures included operating time (153 +/- 44 min), sterile tray usage (14 +/- 3), fluoroscopy screening time (57.2 +/- 23.7 s), operative waste (19 +/- 8 L contaminated, 116 +/- 30 L uncontaminated), and median hospital stay (4 days). The pre-selected kit implants exactly matched intraoperative measurements for 597/639 pedicle screws, 249/258 rods, and 46/148 cages. Pedicle screw placement accuracy was 97.8% (625/639) on postoperative CT. Complications included one intraoperative dural tear, no blood products administered, and six reoperations. Our experience demonstrates a viable application of patient-specific 3D-printed solutions and provides a benchmark for studies of efficiency in spinal fusion surgery. (C) 2019 Elsevier Ltd. All rights reserved.

This report describes a novel method for occipitocervical fixation using a patient-specific, 3D-printed implant and tools. A 79-year-old female presented with progressive neck pain due to a pathologic fracture of C1. DICOM data was used to 3D-print 1:1 scale biomodels of the occipitocervical spine for pre-operative planning, patient education, and intraoperative reference. The surgeon collaborated with engineers to design and 3D-print a titanium patient-specific implant (PSI) and a stereotactic drill guide for occipitocervical screw fixation. The surgical plan specified the occipitocervical "neutral" position, screw sizes, entry points, and trajectories. The PSI was pre-contoured to match the posterior occipitocervical bony spine and reproduce the planned occipitocervical "neutral" position. Stereotactic portholes for screw fixation were integrated into the PSI. The planned "neutral" position was achieved by intraoperatively matching the occipitocervical alignment to the PSI. Screw placement under fluoroscopy was simplified using the stereotactic drill guide. There were no intraoperative or postoperative complications. At 6-month follow up, our patient reported resolution of symptoms and demonstrated satisfactory occipitocervical alignment without evidence of implant dysfunction. Our experience demonstrates that preoperative planning can be combined with biomodelling and 3D-printing to develop patient-specific tools and implants that are viable for occipitocervical fixation surgery.

Despite the variety of “off-the-shelf” implants and instrumentation, outcomes following revision lumbosacral surgery are inconstant. Revision fusion surgery presents a unique set of patient-specific challenges that may not be adequately addressed using universal kits. This study aims to describe how patient-specific factors, surgeon requirements, and healthcare efficiencies were integrated to design and manufacture anatomically matched surgical tools and implants to complement a minimally invasive posterior approach for revision lumbar fusion surgery.

Atlantoaxial transarticular screw fixation is an effective technique for arthrodesis. Surgical accuracy is critical due to the unique anatomy of the atlantoaxial region. lntraoperative aids such as computer assisted navigation and drilling templates offer trajectory guidance but do not eliminate screw malposition. This study reports the operative and clinical performance of a novel process utilising biomodelling and 3D printing to develop patient specific solutions for posterior transarticular atlantoaxial fixation surgery. Software models and 3D printed 1:1 scale biomodels of the patient's bony atlantoaxial spine were developed from computed tomography data for surgical planning. The surgeon collaborated with a local medical device manufacturer using AnatomicsC3D to design patient specific titanium posterior atlantoaxial fixation implants using transarticular and posterior C1 arch screws. Software enabled the surgeon to specify screw trajectories, screw sizes, and simulate corrected atlantoaxial alignment allowing patient specific stereotactic drill guides and titanium posterior fixation implants to be manufactured using 3D printing. Three female patients with unilateral atlantoaxial osteoarthritis were treated using patient specific implants. Transarticular screws were placed using a percutaneous technique with fluoroscopy and neural monitoring. No screw malposition and no neural or vascular injuries were observed. Average operating and fluoroscopy times were 126.0 +/- 4.1 min and 36.7 +/- 11.5 s respectively. Blood loss was <50 ml per patient and length of stay was 4-6 days. Clinical and radiographic follow up data indicate satisfactory outcomes in all patients. This study demonstrates a safe, accurate, efficient, and relatively inexpensive process to stabilise the atlantoaxial spine using transarticular screws. (C) 2018 Elsevier Ltd. All rights reserved.

Department of Surgery, Central Clinical School, Faculty of Medicine, Nursing & Health Sciences, Monash University, Melbourne, Victoria, Australia

The study aims to describe a three-dimensional printed (3DP) posterior fixation implant used for C1/C2 fusion in a 65-year-old female. Spinal fusion remains a common intervention for a range of spinal pathologies including degenerative disc and facet disease when conservative methods are unsuccessful. However, fusion devices are not always entirely efficacious in providing the desired fixation, and surgeons rely on 'off the shelf' implants which may not provide an anatomical fit to address the particular pathology. 3DP refers to a process where three-dimensional objects are created through successive layering of material, so called 'additive manufacturing'. Although this technology enables accurate fabrication of patient-specific orthopaedic and spinal implants, literature on its utilization in this regard is rare. A 65-year-old female, with severe facet arthropathy at the C1/C2 level, osteophyte formation and impingement of the exiting C2 nerve root underwent a C1/C2 posterior fusion and rhizolysis of the C2 nerve roots. A custom posterior fixation implant was designed and on-laid over the C2 spinous process and lamina, with screw holes made to a depth and angulation that was pre-calculated based on the preoperative CT based 3D modelling. The patient had an uneventful recovery and reported a significant reduction in occipital neuralgia and sub-occipital pain and 2-month follow-up. We report the first case of a customized 3DP spinal prosthesis for posterior C1/C2 fusion. The implant added significant value reducing the overall time of the procedure, and safety with a reduced risk of neurovascular compromise.

BACKGROUNDIt is unclear whether decompressive craniectomy improves the functional outcome in patients with severe traumatic brain injury and refractory raised intracranial pressure.METHODSFrom December 2002 through April 2010, we randomly assigned 155 adults with severe diffuse traumatic brain injury and intracranial hypertension that was refractory to first-tier therapies to undergo either bifrontotemporoparietal decompressive craniectomy or standard care. The original primary outcome was an unfavorable outcome (a composite of death, vegetative state, or severe disability), as evaluated on the Extended Glasgow Outcome Scale 6 months after the injury. The final primary outcome was the score on the Extended Glasgow Outcome Scale at 6 months.RESULTSPatients in the craniectomy group, as compared with those in the standard-care group, had less time with intracranial pressures above the treatment threshold (P<0.001), fewer interventions for increased intracranial pressure (P<0.02 for all comparisons), and fewer days in the intensive care unit (ICU) (P<0.001). However, patients undergoing craniectomy had worse scores on the Extended Glasgow Outcome Scale than those receiving standard care (odds ratio for a worse score in the craniectomy group, 1.84; 95% confidence interval [CI], 1.05 to 3.24; P=0.03) and a greater risk of an unfavorable outcome (odds ratio, 2.21; 95% CI, 1.14 to 4.26; P=0.02). Rates of death at 6 months were similar in the craniectomy group (19%) and the standard-care group (18%).CONCLUSIONSIn adults with severe diffuse traumatic brain injury and refractory intracranial hypertension, early bifrontotemporoparietal decompressive craniectomy decreased intracranial pressure and the length of stay in the ICU but was associated with more unfavorable outcomes. (Funded by the National Health and Medical Research Council of Australia and others; DECRA Australian Clinical Trials Registry number, ACTRN012605000009617.).

Traumatic brain injury studies predominantly use an assessment of neurological function some time after hospital discharge as the primary endpoint. Recent studies have followed up patients at 6 months after injury with very variable loss to follow up [1,2]. We have established an outcome process that minimises loss to follow up and maximises the quality of the outcome assessment.

Severe traumatic brain injury (TBI) is a condition often associated with grave consequences and it remains a major public health problem globally. Clinical trials to improve management and treatment of this condition are a necessity; however, there are many issues that impact on the design and conduct of such trials including the complex and sensitive issue of consent. Obtaining consent for severe TBI trials is inherently complicated and difficult because the family are being asked to make an informed decision when they are shocked, anxious, grieving and frequently physically exhausted. We established a process during the DECRA trial to minimise the difficulties and to ensure that consent was obtained with sensitivity and in an informed manner.

Thoracic canal stenosis caused by hypertrophy of the posterior spinal elements is rare. We report an unusual case of bilateral zygapophyseal joint hypertrophy occurring solely at thoracic levels T10–11, producing bilateral leg weakness and numbness. The diagnosis was established using CT scans and MRI. A wide decompressive laminectomy and posterolateral bone fusion was performed. Postoperatively there was a marked improvement in symptoms and signs. We present a literature review on bilateral single-level facet joint hypertrophy producing canal stenosis and report our experience.

PURPOSE:The aims of this study were to test the feasibility and to assess potential recruitment rates in a pilot study preliminary to a phase III randomized trial of decompressive craniectomy surgery in patients with diffuse traumatic brain injury (TBI) and refractory intracranial hypertension. MATERIALS AND METHODS:A study protocol was developed, inclusion and exclusion criteria were defined, and a standardized surgical technique was established. Neurologic outcomes were assessed 6 months after injury with a validated structured questionnaire and a single trained assessor blind to treatment group. RESULTS:During the 8-month pilot study at a level 1 trauma center in Melbourne, Australia, 69 intensive care patients with severe TBI were assessed for inclusion. Six patients were eligible, and 5 (8%) were randomized. Six months after injury, 100% of patients received outcome assessments. Key improvements to the multicenter Decompressive Craniectomy study protocol were enabled by the pilot study. CONCLUSIONS:In patients with severe TBI and refractory intracranial hypertension, the frequency of favorable neurologic outcomes (independent living) was low and similar to predicted values (40% favorable). A future multicenter phase III trial involving 18 neurotrauma centers with most sites conservatively recruiting at just 25% of the pilot study rate would require at least 5 years to achieve an estimated 210-patient sample size. Collaboration with neurotrauma centers in countries other than Australia and New Zealand would be required for such a phase III trial to be successful.

THE USE OF PHYSICAL BIOMODELING IN COMPLEX SPINE SURGERY Maree T Izatt, Paul LPJ Thorpe, Paul S D’Urso, Otto von Arx, Robert G Thompson, Clayton J Adam, John WS Earwaker, Robert D Labrom, Geoffrey N Askin. Paediatric Spine Research Group, Brisbane, Australia. INTRODUCTION Prior studies have suggested that biomodels enhance patient education, pre-operative planning and intra-operative stereotaxy, however the usefulness of biomodels compared to regular imaging modalities such as x-ray, CT and MR has not been quantified. (1) The aim of this study was to quantify surgeons' perceptions on the usefulness of biomodels compared to standard visualisation modalities for pre-operative planning and intra-operative anatomical reference. METHOD Physical biomodels were manufactured for a consecutive series of 26 patients with complex spinal pathologies using a stereolithographic technique based on CT data1. Patients were selected for the technique by the surgeons, if the pathoanatomy was not considered to be clearly displayed by standard imaging techniques . The biomodels were used pre-operatively for assessment of spinal pathology, parent and patient education, obtaining informed consent, surgical planning and customising implants. Intra-operatively, the sterilized biomodel was useful for anatomical reference, surgical navigation and as a teaching aid. Following surgery, a detailed biomodel utility survey was completed by the surgeons (GNA and RDL) for all cases where a biomodel was ordered. RESULTS Twenty one deformity and five tumour cases were performed using biomodels. Surgeons stated that the anatomical detail was better visible on the biomodel than on other imaging modalities in 17 (65%) cases, and exclusively visible on the biomodel in 3 (11%) cases. Preoperative use of the biomodel led to a different decision regarding the choice of osteosynthetic materials used in 14 (52%) cases, and the implantation site of osteosynthetic material in 20 (74%) cases. Biomodels were found to be highly accurate in relation to anatomy identified during the surgery when compared with other visualization modalities and resulted in improved communication with patients/parents and informed consent in 25 (96%) cases. Surgeons reported that the use of biomodels reduced operating times in 23 (89%) cases by a mean of 63 minutes per case (range 0-180mins) which included 8% (range 0-125mins) in tumour patients and 22% (range 30-180mins) in deformity procedures, and therefore surgical costs were often subsequently reduced despite the additional cost of the biomodel. In all cases, the surgeons reported the model had a positive effect on the outcome of the surgical procedure and that they would order a biomodel again should a similar case present. DISCUSSION This study supports physical biomodeling as a useful, and sometimes essential tool in the armamentarium of imaging techniques used for complex spinal surgery. REFERENCES 1.D’Urso PS, Askin GN, Earwaker WJS, Merry GS, Thompson RG, Barker TM, Effeney DJ. Spinal Biomodeling, SPINE 24(12): 1247-51, 1999.

Prior studies have suggested that biomodels enhance patient education, preoperative planning and intra-operative stereotaxy; however, the usefulness of biomodels compared to regular imaging modalities such as X-ray, CT and MR has not been quantified. Our objective was to quantify the surgeon's perceptions on the usefulness of biomodels compared to standard visualisation modalities for preoperative planning and intra-operative anatomical reference. Physical biomodels were manufactured for a series of 26 consecutive patients with complex spinal pathologies using a stereolithographic technique based on CT data. The biomodels were used preoperatively for surgical planning and customising implants, and intra-operatively for anatomical reference. Following surgery, a detailed biomodel utility survey was completed by the surgeons, and informal telephone interviews were conducted with patients. Using biomodels, 21 deformity and 5 tumour cases were performed. Surgeons stated that the anatomical details were better visible on the biomodel than on other imaging modalities in 65% of cases, and exclusively visible on the biomodel in 11% of cases. Preoperative use of the biomodel led to a different decision regarding the choice of osteosynthetic materials used in 52% of cases, and the implantation site of osteosynthetic material in 74% of cases. Surgeons reported that the use of biomodels reduced operating time by a mean of 8% in tumour patients and 22% in deformity procedures. This study supports biomodelling as a useful, and sometimes essential tool in the armamentarium of imaging techniques used for complex spinal surgery.

Most aneurysms can be effectively managed using endovascular coiling or microsurgical clipping, but in an acute subarachnoid haemorrhage where there are multiple aneurysms identified, a sequential multimodal approach may prove more beneficial. This report involves a 31-year-old man who presented with sudden onset of severe headache and photophobia. A computed tomography brain scan revealed a diffuse grade II subarachnoid haemorrhagic pattern, and four-vessel angiography revealed two aneurysms: a right middle cerebral artery bifurcation aneurysm measuring 12×8mm and a 4-mm basilar artery aneurysm associated with a fenestration at the confluence of the vertebral arteries. It was not possible to determine which aneurysm or aneurysms were responsible for the haemorrhage using the customary criteria. The patient underwent sequential endovascular coiling of the vertebrobasilar aneurysm without delay, followed immediately by microsurgical clipping of the right middle cerebral artery aneurysm, under a single anaesthetic. The postoperative course was uneventful. This method is a treatment option for acute subarachnoid haemorrhage where there are multiple aneurysms. It is a logical progression of management that could be employed at any experienced neurovascular centre; the employment of a sequential multimodal approach from the integration of these techniques is beneficial to the patient because it decreases morbidity and mortality.

Introduction: Clival chordomas represent skull base tumors with epithelial and mesenchymal aspects that show a high propensity for local recurrence and distant metastases through both the systemic and cerebrospinal routes. Even today these tumors maintain a high recurrence rate after surgery, especially in those cases involving the anterior cranial fossa and facial structures. The most effective first-line treatment for clival chordomas is surgery, but some studies demonstrated that a combined multimodality therapy including surgery and chemoradiotherapy may prolong the survival rate of these patients. To date, a trans-sphenoidal approach to treat clival chordomas, as well its technical variants, offers an excellent alternative to standard skull base approaches achieving the avoidance of a prolonged exposure time and brain retraction. The paper reports three cases of midline extradural clival chordomas operated via trans-sphenoidal approach and their clinical outcomes.

STUDY DESIGN:Prospective trial. OBJECTIVE:To develop and validate a new method of spinal stereotaxy. SUMMARY OF BACKGROUND DATA:Biomodeling has been found to be helpful for complex skeletal surgery. Frameless stereotaxy has been used for spinal surgery but has significant limitations. A novel stereotactic technique using biomodels has been developed. METHODS:Twenty patients with complex spinal disorders requiring instrumentation were recruited. A three-dimensional CT scan of their spine was performed, and the data were transferred via a DICOM network to a computer workstation. ANATOMICS BIOBUILD software was used to generate the code required to manufacture exact acrylate biomodels of each spine using rapid prototyping. The biomodels were used to obtain informed consent from patients and to simulate surgery. Simulation was performed using a standard power drill to place trajectory pins into the spinal biomodel. Acrylate drill guides were manufactured using the biomodels and trajectory pins as templates. The biomodels and drill guides were sterilized and used intraoperatively to assist with surgical navigation and the placement of instrumentation. RESULTS:The biomodels were found to be highly accurate and of great assistance in the planning and execution of the surgery. The ability to drill optimum screw trajectories into the biomodel and then accurately replicate the trajectory was judged especially helpful. Accurate screw placement was confirmed with postoperative CT scanning. The design of the first two templates was suboptimal as the contact surface area was too great and complex. Approximately 20 minutes was spent before surgery preparing each biomodel and template. Operating time was reduced, as less reliance on intraoperative radiograph was necessary. Patients stated that the biomodels improved informed consent. CONCLUSIONS:The authors have developed a novel method of spinal stereotaxy using exact plastic copies of the spine manufactured using biomodeling technology. Biomodel spinal stereotaxy is a simple and accurate technique that may have advantages over frameless stereotaxy.