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.

Surgical treatment of a spontaneous spinal epidural hematoma under antithrombotic treatment of a multisystem inflammatory syndrome in children associated with SARS-COV-2.

Multisystem inflammatory syndrome in children (MIS-C) is a novel syndrome of multisystemic inflammation affecting children. This case report documents an exceptional and severe complication of an epidural hematoma in a 3-year-old boy under the treatment of MIS-C. During the course of the disease, the patient suffered from a hypocoagulable state and an extensive multisegmental epidural hematoma in the cervical spinal canal. This led to severe anterior spinal cord compression and tetraparesis. Extensive emergency surgery had to be carried out to reverse rapid clinical deterioration.

Clinical and radiological outcome 1-year after cervical total disc replacement using the Signus ROTAIO - Prosthesis.

INTRODUCTION: The instantaneous center of rotation (iCOR) of a motion segment has been shown to correlate with its total range of motion (ROM). Importantly, a correlation of the correct placement of cervical total disc replacement (cTDR) to preserve a physiological iCOR has been previously identified. However, changes of these parameters and the corresponding clinical relevance have hardly been analyzed. This study assesses the radiological and clinical correlation of iCOR and ROM following cTDR. MATERIALS/METHODS: A retrospective multi-center observational study was conducted and radiological as well as clinical parameters were evaluated preoperatively and 1 year after cTDR with an unconstrained device. Radiographic parameters including flexion/extension X-rays (flex/ex), ROM, iCOR and the implant position in anterior-posterior direction (IP ap), as well as corresponding clinical parameters [(Neck Disability Index (NDI) and the visual analogue scale (VAS)] were assessed. RESULTS: 57 index segments of 53 patients treated with cTDR were analyzed. Pre- and post-operative ROM showed no significant changes (8.0° vs. 10.9°; p > 0.05). Significant correlations between iCOR and IP (Pearson's R: 0.6; p < 0.01) as well as between ROM and IP ap (Pearson's R: - 0.3; p = 0.04) were identified. NDI and VAS improved significantly (p < 0.01). A significant correlation between NDI and IP ap after 12 months (Pearson's R: - 0.39; p < 0.01) was found. CONCLUSION: Implantation of the tested prosthesis maintains the ROM and results in a physiological iCOR. The exact position of the device correlates with the clinical outcome and emphasize the importance of implant design and precise implant positioning.

Cranioplasty following decompressive craniectomy: minor surgical complexity but still high periprocedural complication rates.

Cranioplasty following decompressive craniectomy is of low surgical complexity, so much so that it has become the "beginners" cranial case. However, these "simple" procedures may have high complication rates. Identification of specific risk factors would allow targeted intervention to lower the complication rates. The aim of this study was to assess the rate of complications and to evaluate potential risk factors. We conducted a review of all patients who underwent cranioplasty in our center following decompressive craniectomy for stroke or brain trauma between 2009 and 2016. One hundred fifty-two patients were identified. Fifty-three percent were male. Mean age was 48 (range 11-78). Median time from craniectomy until cranioplasty was 102 days (range 14-378). The overall rate of complications, such as postoperative bleeding, seizures, postoperative infection, and hydrocephalus, was 30%. The mortality rate was 1%. None of the following potential risk factors was associated with significantly increased risk of periprocedural complications: gender (p = 0.34), age (p = 0.39), cause of initial surgery (p = 0.08), duration of surgery (p = 0.59), time of surgery (0.24), surgical experience (p = 0.17), and time from craniectomy until cranioplasty (p = 0.27). The 30-day complication rate following cranioplasty is high, but serious permanent deficits from these complications were rare. We found no clear predictor for these 30-day complications, which renders its prevention difficult.

Inaccuracy of standard geriatric scores in nonagenarians following hospitalization for various spinal pathologies.

Demographic trends make it incumbent on spine surgeons to recognize the special challenges involved in caring for older patients. The aim of this study was to identify variables that may predict early mortality in geriatric patients over the age of 90 following elective hospitalization for various spinal pathologies. Retrospective analyses of all patients over the age of 90 years, which were electively treated between 2006 and 2016 at out department for various spinal conditions, were performed. Patient characteristics, type of treatment, and comorbidities were analyzed with regard to the 30-day mortality rate. Twenty-six patients were identified. Mean age was 93 years (range 91-97), 19 (73%) were female. Eighteen (69%) patients were treated operatively. Mean hospital stay was 13 days (range 2-51). Seventeen (65%) patients were on anticoagulation therapy. Mean Charlson Comorbidity Index (CCI) was 5.3 (range 1-11); mean diagnosis count (DC) was 8.3 (range 2-17); mean Geriatric Index of Comorbidity (GIC) was 2.8 (range 1-4); and mean comorbidity-polypharmacy score (GPS) was 13.3 (range 5-23). The 30-day mortality rate was 16.7% in the surgically treated group compared with 12.5% in the conservatively treated group (p = 0.9), anticoagulation therapy (p = 0.91), gender (p = 0.49), length of hospital stay (p = 0.33), GIC (p = 0.54), CCI (p = 0.74), GPS (p = 0.82), and DC (p = 0.65) did not correlate with the 30-day mortality rate. Cause of death was pulmonary embolism in two cases and unknown in one case. Thirty-day mortality rate in patients over 90 years old with degenerative spinal diseases is relatively high regardless of the treatment modality. Standard geriatric prognostic scores seem less reliable for these patients.

MRI criteria of subtypes of adenomas and epithelial cysts of the pituitary gland.

This study aimed to assess the clinical applicability of MRI criteria for differentiation of pituitary adenomas and cystic pituitary lesions. One hundred ninety-eight consecutive patients with surgical resection of a pituitary adenoma/cystic pituitary lesion were retrospectively analyzed, blinded to clinical data and histopathological diagnosis. Different morphologic criteria were assessed: signal intensity in T2/T1w images, pattern of contrast enhancement, size, super-/infrasellar extension, and invasion of the cavernous sinus. For validation of the criteria, a second independent patient cohort (n = 102) was analyzed for diagnostic accuracy of the criteria. We identified differences between subtypes of pituitary adenomas regarding morphological MRI criteria. Especially, ACTH-producing adenomas and GH-producing adenomas showed partially specific imaging features. Application of our criteria on the second patient cohort (n = 102) did however not significantly improve diagnostic accuracy. Only differentiation between cystic pituitary lesions and adenomas was facilitated using these criteria, but did not reach statistical significance in this cohort (P = 0.352). MRI criteria might facilitate differentiation between pituitary adenomas and cystic pituitary lesions, but not between subtypes of pituitary adenomas. These subtypes show partially specific MR imaging features, however, due to a high variability knowledge of clinical symptoms and laboratory findings remain essential for the correct diagnosis.

Fusiform aneurysms of the vertebrobasilar complex: a single-center series.

BACKGROUND: Fusiform vertebrobasilar aneurysms (FVBAs) may exhibit a disastrous clinical course. Due to their rare occurrence, evidence concerning optimal management is lackluster. OBJECTIVE: To describe the epidemiology, clinical features and treatment outcomes of a consecutive series of patients admitted to our institution. METHODS: We retrospectively evaluated patient charts with respect to clinical presentation, treatment procedures, and the outcomes of all patients diagnosed with an FVBA, which were seen at our institution between March 2006 and February 2017. RESULTS: Forty-five consecutive patients were analyzed. Follow-up was available for 39 patients (86.7%) with a median duration of 28.8 months. Seventeen patients (37.7%) were asymptomatic, 14 patients (31.1%) presented with brainstem ischemia, 8 patients (17.8%) with supratentorial ischemia, and 3 (6.7%) patients with brain stem compression. Aneurysm rupture occurred in 3 patients upon presentation (6.7%). Initially, 19 patients (42.2%) were significantly disabled with Modified Rankin Scale (mRS) scores ≥ 3. Twelve patients (26.7%) underwent invasive treatment: endovascular therapy in 9 cases and surgical treatment in 3 cases. Thirty-three patients received conservative treatment. During follow-up, 6 events (66.7%) of severe disability or death (mRS 4-6) occurred in the endovascular group versus 1 event (33%) in the surgical group versus 19 events (63.3%) among conservatively treated aneurysms. Deterioration was significantly more frequent in patients with symptomatic aneurysms (p = 0.030). CONCLUSION: Patients harboring an FVBA frequently present with disabling symptoms caused by various pathomechanisms. The natural history is aggressive, mostly for initially symptomatic aneurysms, and periprocedural morbidity of surgical or endovascular treatment remains substantial.

Radiographic measurements of cervical alignment, fusion and subsidence after ACDF surgery and their impact on clinical outcome.

BACKGROUND: Some recent studies indicate correlations between cervical alignment and clinical outcome after anterior cervical discectomy and fusion (ACDF) surgery. However, there still are no established criteria for the interpretation of alignment, fusion and subsidence in relation to clinical outcome. METHODS: A retrospective analysis of 208 radiographs of patients following ACDF with stand-alone PEEK cage implantation was performed. The measurements were obtained on plain radiographs in lateral and anteroposterior projections as well as flexion/extension radiographs. Cervical alignment was measured using the Gore, Laing and Cobb methods; fusion was evaluated by an assortment of radiographic hallmarks: the presence of bridging bone, the Cobb angle and the distances between the tips and bases of the spinous processes of the operated segments, respectively. For assessment of subsidence, we used the Mochida method in addition to ventral and dorsal segmental height reduction. Correlation analysis between the different radiological characteristics and clinical outcome at a minimum follow-up of 12 months was conducted. RESULTS: Two hundred and eight patients were evaluated for alignment, fusion and subsidence. Cervical alignment using the Gore and Cobb methods correlated among each other, but failed to exhibit significant correlation with clinical outcome. Interpretation of fusion rates varied greatly (43.9 to 89.4%) depending on the criteria used. Pearson coefficients between radiographic presence of pseudarthrosis and the measurements of the spinous process distances (0.595; p < 0.001), the Cobb angles (0.187; p = 0.007) and the presence of bridging bone (0.224; p < 0.001) each exhibited statistical significance. None of the methods employed significantly correlated with clinical outcome. Regarding subsidence, we found rates of 62%, 48% and 27% using the Mochida, ventral and dorsal segmental height reduction assessment methods, respectively. Pearson correlations between pairs of Mochida/ventral (r = 0.39; p = 0.66) and Mochida/dorsal (r = 0.007; p = 0.921) height reduction assessment methods were weak and no significant correlation between subsidence rates and clinical outcome was shown. CONCLUSION: All measured parameters varied depending in the measurement method used. This was most pronounced for fusion. There was a moderate positive correlation between neck pain and subsidence as measured by the Mochida method.

Working ability and use of healthcare resources for patients with trigeminal neuralgia treated via microvascular decompression.

BACKGROUND: Trigeminal neuralgia (TN) is defined as sudden, usually unilateral, severe, brief, stabbing and recurrent episodes of pain in one or more branches of the trigeminal nerve. In patients with TN refractory to medical therapy, microvascular decompression (MVD) is considered. TN interferes with daily functioning and is associated with depression and anxiety. Direct costs of MVD are high, but the procedure is believed to improve working ability and reduce the use of medical resources. This study aims to analyse MVD's effects on TN patients regarding work capacity, healthcare utilisation and health-related quality of life (hrQoL). METHODS: We conducted a cross-sectional survey of patients who underwent MVD for TN between 2007 and 2016 (n = 46). The patients' outcome, work capacity and use of medical resources were assessed via the Barrow Neurological Institute Pain Intensity Score (BNI Score), with questions regarding patients' employment status, restrictions in work capacity, healthcare utilisation and completion of the EQ5D questionnaire. RESULTS: The response rate was 28/46 (61%). The majority of the participants (20/28) reported feeling strongly/quite handicapped in productivity due to TN preoperatively, which was also indicated by a few participants (3/28) postoperatively (p = < 0.01). Pain-related days off work were reduced postoperatively from 21 to 4 (p = 0.059) on average. Postoperative hrQoL did not differ from the general German population. Further reductions in healthcare utilisation and private costs were shown. CONCLUSION: In TN, MVD alleviates patient burden, especially concerning productivity and the consumption of health resources.

No correlation between radiological and clinical outcome 1 year following cervical arthrodesis.

AIM: To correlate clinical and radiological outcome following one- and two-level anterior cervical discectomy and fusion (ACDF) with stand-alone polyetheretherketone (PEEK) cages filled with demineralized bone matrix (DBM). METHODS: We performed a retrospective review of a consecutive patient cohort with degenerative disc disease that underwent ACDF with stand-alone PEEK cages filled with demineralized bone matrix (DBM) between 2010 and 2013 with a minimum follow-up of 12 months. Changes in the operated segments were measured and compared to radiographs directly after surgery. Clinical outcome was evaluated by a physical examination, pain by visual analog scale (VAS) for arm and neck. Health-related quality of life was measured using the EuroQOL questionnaire (EQ-5D). RESULTS: Of 282 consecutive cases, follow-up data were obtained from 194 (69%) cases. The median age at presentation was 54 years and 91 patients were male (46%). Ninety-eight and 96 patients had one- and two-level surgeries, respectively. Mean VAS pain was reduced from 5.2 ± 3.6 to 2.6 ± 2.4 (p < 0.001) and from 5.8 ± 3.3 to 2.1 ± 2.7 (p < 0.001) in the myelopathy and radiculopathy group, respectively. Fusion was achieved in 79 and 82% of segments in one- and two-level surgeries, respectively. Cervical alignment was better in 10 and 1%, similar in 68 and 76%, worse in 23 and 23% in one- and two-level surgeries, respectively. Subsidence was observed in 44 and 34% of segments in one- and two-level surgeries, respectively. Follow-up operations due to symptomatic adjacent disc disease or implant failure were needed in 13 (7%) and 15 (8%) of cases, respectively. Subsidence, adjacent disc disease, and cervical alignment all had no influence on the clinical outcome. CONCLUSIONS: The clinical outcome after ACDF with PEEK cages filled with demineralized bone matrix is highly satisfactory. Radiological signs of non-fusion, subsidence, and cervical alignment have no influence on clinical outcome.

Patients' beliefs about diagnosis and treatment of cervical spondylosis with radiculopathy.

BACKGROUND: The clinical results of surgical spine care may be influenced by the patients' understanding and knowledge of his or her condition, treatment options and decision-making process. The aim of this survey study was to evaluate certain beliefs and opinions of patients with a degenerative condition in the cervical spine with a history of cervical radiculopathy such as importance of magnetic resonance imaging, risk factors, treatment alternatives and effectiveness. METHODS: An anonymous questionnaire survey was performed on two different patient populations with a degenerative condition in the cervical spine with a history of cervical radiculopathy referred to the outpatients' clinics of two neurosurgical departments in Germany and Norway. The survey consisted of seven questions: four questions about the respondents' gender and age, history of previous spine surgery and/or conservative treatment for cervical disorder and three questions regarding the importance of imaging in the decision-making process, patients' willingness to undergo cervical surgery based on imaging findings even with few or no symptoms and the effectiveness of surgical or conservative treatment. RESULTS: Two hundred eleven patients answered the questionnaire. Sixty-seven percent of all patients with a degenerative cervical condition believe that results from MRI studies are more important than clinical findings. Forty-seven percent were willing to undergo surgery based on MRI showing abnormalities even without or having few symptoms. Fifty percent believe that surgery is more effective in the treatment of axial neck pain. CONCLUSION: Misbeliefs and misconceptions exist concerning certain aspects of the diagnosis and management in patients with degenerative conditions in the cervical spine with a history of cervical radiculopathy in a large proportion of patients referred to neurosurgical outpatient clinics.

Predictive value of transcranial evoked potentials during mechanical endovascular therapy for acute ischaemic stroke: a feasibility study.

BACKGROUND AND PURPOSE: Mechanical endovascular therapy (MET) is a promising adjuvant or stand-alone therapy for acute ischaemic stroke caused by occlusion of a large vessel. Real-time monitoring of recanalisation success with regard to functional outcome is usually not possible because these procedures are mainly performed under general anaesthesia. We present a novel application for evoked potential monitoring for real-time evaluation of reperfusion success with respect to functional outcome during MET for acute ischaemic stroke. METHODS: Prospective observational study from March 2012 to April 2013 of patients presenting with acute ischaemic stroke who were eligible for MET. Transcranial motor evoked potentials (MEPs) and somatosensory evoked potentials (SSEPs) were measured bilaterally during MET throughout the intervention. The electrophysiological data of the contralateral side served as control. Neurological outcome was assessed by the modified Rankin Scale and National Institutes of Health Stroke Scale at 0, 7 and 90 days following intervention. RESULTS: 20 patients were examined. MEPs and SSEPs were technically successful in 19 (95%) and 9 (45%) cases, respectively. Successful reperfusion was achieved in 16 cases. Functional recovery was observed in 14 patients. MEPs and SSEPs recovery status was a better predictor of functional recovery than successful reperfusion with a positive predictive value of 92%, 83% and 75% for MEPs, SSEPs and reperfusion, respectively. CONCLUSIONS: MEPs and SSEPs are safe and feasible methods of real-time monitoring of reperfusion success with respect to functional outcome during MET for acute ischaemic stroke.

Clinical and radiological outcome after anterior cervical discectomy and fusion with stand-alone empty polyetheretherketone (PEEK) cages.

OBJECTIVE: To evaluate long-term results after one-, two-, and three-level anterior cervical discectomy and fusion (ACDF) with stand-alone empty polyetheretherketone (PEEK) cages. METHODS: We performed a retrospective review of a consecutive patient cohort that underwent ACDF with stand-alone empty PEEK cages between 2007 and 2010 with a minimum follow-up of 12 months. Radiographic follow-up included static and flexion/extension radiographs. Changes in the operated segments were measured and compared to radiographs directly after surgery. Clinical outcome was evaluated by a physical examination, pain visual analog scale (VAS), and health-related quality of life (HRQL) using the EuroQOL questionnaire (EQ-5D). Analysis of associations between fusion, subsidence, cervical alignment, and clinical outcome parameters were performed. RESULTS: Of 407 consecutive cases, 318 met all inclusion criteria. Follow-up data were obtained from 265 (83 %) cases. The mean age at presentation was 55 years and 139 patients were male (52 %). In the sample, 127, 125, and 13 patients had one-, two-, and three-level surgeries, respectively; 132 (49 %) presented with spondylotic cervical myelopathy and 133 (50 %) with cervical radiculopathy. Fusion was achieved in 85, 95, and 94 % of segments in one-, two-, and three-level surgeries, respectively. Non-fusion was associated with higher VAS pain levels. Radiographic adjacent segment disease (ASD) was observed in 20, 29, and 15 % in one-, two-, and three-level surgeries, respectively. ASD was associated with lower HRQL. Subsidence was observed in 25, 27, and 15 % of segments in one-, two-, and three-level surgeries, respectively. However, this had no influence on clinical outcome. Follow-up operations for symptomatic adjacent disc disease and implant failure at index level were needed in 16 (6 %) and four (1.5 %) cases, respectively. Younger age was associated with better clinical outcome. Multilevel surgery favored better myelopathy outcomes and fusion reduced overall pain. ASD worsened EuroQOL-Index values. Worsening of the cervical alignment induced arm pain. CONCLUSIONS: One- and two-level ACDF with stand-alone empty PEEK cages achieved very high fusion rates and a low rate of follow-up operations. The rate of good clinical outcome is highly satisfactory. Younger age was the single most influential factor associated with better clinical outcome.

Safety and efficacy of polyetheretherketone (PEEK) cages in combination with posterior pedicel screw fixation in pyogenic spinal infection.

BACKGROUND: To date, there is growing consensus that PEEK material may be used for interbody fusion in spinal infections. Data supporting that claim are however restricted to a few very small clinical series. The aim of this study is to evaluate the outcome of surgical treatment of pyogenic spinal infections with PEEK cages in combination with posterior pedicel screw fixation. METHODS: Between 2006 and 2013, a total of 211 patients suffering from spondylodiscitis underwent surgical debridement and instrumentation. There were 52 cases where PEEK cages were used. Laboratory and physical examinations were assessed at a 3-month follow-up. Last follow-up was performed with at a minimum of 12 months after surgery via a telephone interview. RESULTS: Mean age at presentation was 67 years, with 19 (37 %) male patients and 33 (63 %) female. Distribution of the infection was lumbar in 29 (56 %%), thoracic in 3 (6 %) and cervical in 11 (21 %) cases. Nine patients (17 %) had concomitant non-contiguous spondylodiscitis. Epidural abscess was found in 17 patients (33 %); 48 (92 %%) had pain; neurological deficits were found in 20 patients (38 %). All patients in this series underwent surgical debridement with instrumentation of the spine. Postoperative intravenous antibiotics were administered for 15.4 ± 6.8 days followed by 2.9 ± 0.5 months of oral antibiotics. Complete resolution of the infection was achieved in all cases. Of the 28 patients with neurological deficits, 6 had full recovery and 10 had improved incompletely after surgery. One patient suffered from a pulmonary embolism postoperatively. There were no mortalities. CONCLUSIONS: Use of PEEK cages for interbody fusion is feasible and safe in patients suffering from a pyogenic spinal infection.

Poor diagnostic accuracy of transcranial motor and somatosensory evoked potential monitoring during brainstem cavernoma resection.

OBJECTIVE: Microsurgical resection of brainstem cavernomas carries a high risk of new postoperative morbidity such as cranial nerve, motor and sensory deficits as well as functional deterioration. Intraoperative monitoring is used to avoid impending damage to these highly eloquent tracts. However, data on neurophysiological monitoring during resection of brainstem cavernomas are lacking. METHODS: Consecutive patients with brainstem cavernomas who underwent surgical removal from June 2007 to December 2014 were retrospectively analysed. Transcranial motor-evoked potential (MEP) and somatosensory-evoked potential (SSEP) monitorings were performed in all cases. The evoked potential (EP) monitoring data were reviewed and related to new postoperative motor and sensory deficits and postoperative imaging. Clinical outcomes were assessed during follow-up. RESULTS: Twenty-six consecutive patients with brainstem cavernoma underwent 27 surgical resections within this study. MEP and SSEP monitoring was technically feasible in 26 and 27 cases, respectively. MEP sensitivity and specificity were 33 and 88 %, respectively. MEP positive and negative predictive values were 28 and 78 %, respectively. SSEP sensitivity and specificity were 20 and 81 %, respectively. SSEP positive and negative predictive values were 20 and 81 %, respectively. CONCLUSION: In continuous MEP and SSEP monitoring during brainstem cavernoma microsurgery, high rates of false-positive and -negative results are encountered, resulting in low positive and relatively high negative predictive values. Careful interpretation of the intraoperative monitoring results is essential in order to avoid potentially unjustified termination of brainstem cavernoma resection.

European randomized controlled trial evaluating differential target multiplexed spinal cord stimulation and conventional medical management in subjects with persistent back pain ineligible for spine surgery: 24-month results.

BACKGROUND: Differential target multiplexed spinal cord stimulation (DTM SCS) was shown to be superior to conventional SCS for treating chronic low back pain (CLBP) in subjects with persistent spinal pain syndrome with previous spinal surgery (PSPS-T2) or ineligible for it (PSPS-T1). This study reports 24-month efficacy and safety of DTM SCS vs. conventional medical management (CMM) in PSPS-T1 subjects across four European countries. METHODS: This is a prospective, multicenter, open-label, randomized, controlled trial with optional crossover. Subjects randomized 1:1 to DTM SCS or CMM. Primary endpoint was responder rate (% subjects reporting ≥50% CLBP relief) at 6 months. A superiority test compared responder rates between treatments. CLBP and leg pain levels, functional disability, quality of life (QoL), patient satisfaction and global impression of change were evaluated for 24 months. A Composite Responder Index (CRI) was obtained using CLBP relief, disability and QoL. Incidence of study-related adverse events evaluated safety. RESULTS: A total of 55 and 57 subjects were randomized to DTM SCS and CMM respectively. DTM SCS was superior, with CLBP responder rates ≥80% and CLBP relief >5.6 cm (>70% reduction) through the 24-month follow-up. Improvements with DTM SCS in other outcomes were sustained. The CRI was >80% for DTM SCS through 24 months. Opioid medication intake decreased in subjects treated with DTM SCS. Most patients treated with DTM SCS felt satisfied and improved at the end of the study. Safety was congruent with other studies. CONCLUSION: DTM SCS is efficacious and safe during 24 months for the treatment of CLBP and leg pain in PSPS-T1 patients ineligible for spine surgery. SIGNIFICANCE STATEMENT: This randomized controlled trial shows that Differential Target Multiplexed SCS (DTM SCS) is an effective and safe long-term treatment for PSPS type 1 patients suffering from axial low back pain with or without leg pain and who are ineligible for spinal surgery. Currently, CMM treatments are their only option and provide limited benefits. Besides superior pain relief, DTM SCS provides significant improvements in functional disability, quality of life, high levels of satisfaction and perceived impression of change.

Surgical Outcome of Patients With Supratentorial Meningiomas Aged 80 Years or Older-Retrospective International Multicenter Study.

BACKGROUND AND OBJECTIVES: Demographic changes will lead to an increase in old patients, a population with significant risk of postoperative morbidity and mortality, requiring neurosurgery for meningiomas. This multicenter study aims to report neurofunctional status after resection of patients with supratentorial meningioma aged 80 years or older, to identify factors associated with outcome, and to validate a previously proposed decision support tool. METHODS: Neurofunctional status was assessed by the Karnofsky Performance Scale (KPS). Patients were categorized in poor (KPS ≤40), intermediate (KPS 50-70), and good (KPS ≥80) preoperative subgroups. Volumetric analyses of tumor and peritumoral brain edema (PTBE) were performed; volumes were scored as small (<10 cm 3 ), medium (10-50 cm 3 ), and large (>50 cm 3 ). RESULTS: The study population consisted of 262 patients, and the median age at surgery was 83.0 years. The median preoperative KPS was 70; 117 (44.7%) patients were allotted to the good, 113 (43.1%) to the intermediate, and 32 (12.2%) to the poor subgroup. The median tumor and PTBE volumes were 30.2 cm 3 and 27.3 cm 3 ; large PTBE volume correlated with poor preoperative KPS status ( P = .008). The 90-day and 1-year mortality rates were 9.0% and 13.2%, respectively. Within the first postoperative year, 101 (38.5%) patients improved, 87 (33.2%) were unchanged, and 74 (28.2%) were functionally worse (including deaths). Each year increase of age associated with 44% (23%-70%) increased risk of 90-day and 1-year mortality. In total, 111 (42.4%) patients suffered from surgery-associated complications. Maximum tumor diameter ≥5 cm (odds ratio 1.87 [1.12-3.13]) and large tumor volume (odds ratio 2.35 [1.01-5.50]) associated with increased risk of complications. Among patients with poor preoperative status and large PTBE, most (58.3%) benefited from surgery. CONCLUSION: Patients with poor preoperative neurofunctional status and large PTBE most often showed postoperative improvements. The decision support tool may be of help in identifying cases that most likely benefit from surgery.

Impact of anterior clinoidectomy on visual function after resection of meningiomas in and around the optic canal.

BACKGROUND: Meningiomas of the anterior and middle skull base frequently involve the optic nerve and cause progressive visual impairment. Surgical decompression of the optic nerve is the only option to preserve visual function. Depending on the invaded structures, optic nerve decompression can be part of a complete tumor removal or the main surgical intention in terms of local debulking. However, bony decompression of the optic canal including anterior clinoidectomy for optic nerve decompression is still a surgical maneuver under discussion. METHODS: From 2006 to 2011, 46 consecutive patients with skull base meningiomas in and around the optic canal were operated. The pterional approach was tailored for each patient. Resection included bony decompression of the optic canal with or without anterior clinoidectomy. Visual acuity and fields were evaluated pre- and postoperatively. RESULTS: Fifty-three percent of patients underwent anterior clinoidectomy, 23 % optic canal unroofing, and 24 % any bony decompression. In 21 patients (46 %), gross total resection (GTR, Simpson grade I or II) was achieved, while 25 patients (54 %) received subtotal resection (STR, Simpson grade III or IV). Sixty-three percent of patients presented with preoperative visual impairment. Postoperative visual changes were significantly related to preoperative visual function. While all patients with normal preoperative vision remained unchanged, in patients with impaired vision, surgery caused improvement in 70 % and deterioration in 10 % of patients (p < 0.0001). In patients with anterior clinoidectomy, vision improved more frequently than without anterior clinoidectomy (p < 0.05). CONCLUSIONS: Anterior clinoidectomy is safe and may improve visual outcome in meningiomas in and around the optic canal.

Robot-assisted versus navigated transpedicular spine fusion: A comparative study.

BACKGROUND: The aim of this study was to compare the intraoperative and postoperative outcomes between a robot-assisted versus a navigated transpedicular fusion technique. METHODS: This retrospective analysis included patients who underwent transpedicular posterior fusion of the spine due to trauma, pyogenic spondylodiscitis and osteoporosis. Surgery was done either with a robot-assisted or a percutaneous navigated transpedicular fusion technique. The outcome analysis included the duration of surgery, the radiation exposure, the postoperative screw position and complications. RESULTS: A total of 60 patients were operated and 491 screws were analysed. No statistical difference was seen in the applied cumulative effective radiation dose per patient. The radiological assessment revealed a more accurate screw placement with robot assistance. A learning curve could be observed in robot-assisted fusion. CONCLUSION: Robot-assisted and navigated transpedicular fusion techniques are both effective and safe. Robot-assisted transpedicular spine fusion goes along with higher placement accuracy but its implementation needs an adequate learning curve.

sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE): a prospective multicentre RCT.

INTRODUCTION: Persistent spine pain syndrome type 2 (PSPS2) represents a significant burden to the individual and society. Treatment options include revision surgery, stabilisation surgery of the spine, neuromodulation, analgesics and cognitive behavioural therapy. Nevertheless, structured treatment algorithms are missing as high-level evidence on the various treatments is sparse. The aim of this study is to compare higher frequency neuromodulation with instrumentation surgery in patients suffering from PSPS2. METHODS AND ANALYSIS: The sPinal coRd stimulatiOn coMpared with lumbar InStrumEntation for low back pain after previous lumbar decompression (PROMISE) trial is a prospective randomised rater blinded multicentre study. Patients suffering from PSPS2 with a functional burden of Oswestry Disability Index (ODI) >20 points are randomised to treatment via spinal cord stimulation or spinal instrumentation. Primary outcome is back-related functional outcome according to the ODI 12 months after treatment. Secondary outcomes include pain perception (visual analogue scale), Short Form-36, EuroQOL5D, the amount of analgesics, the length of periprocedural hospitalisation and adverse events. Follow-up visits are planned at 3 and 12 months after treatment. Patients with previous lumbar instrumentation, symptomatic spinal stenosis, radiographical apparent spinal instability or severe psychiatric or systemic comorbidities are excluded from the study. In order to detect a significant difference of ≥10 points (ODI) with a power of 80%, n=72 patients need to be included. The recruitment period will be 24 months with a subsequent 12 months follow-up. The beginning of enrolment is planned for October 2022. ETHICS AND DISSEMINATION: The PROMISE trial is the first randomised rater blinded multicentre study comparing the functional effectiveness of spinal instrumentation versus neuromodulation in patients with PSPS2 in order to achieve high-level evidence for these commonly used treatment options in this severely disabling condition. Patient recruitment will be performed at regular outpatient clinic visits. No further (print, social media) publicity is planned. The study is approved by the local ethics committee (LMU Munich, Germany) and will be conducted according to the Declaration of Helsinki. TRIAL REGISTRATION NUMBER: NCT05466110.