Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants: 24-Month Follow-Up.

BACKGROUND: Strong evidence supports minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To report safety and effectiveness of SIJF using a 3D-printed TTI at 24 months. METHODS: SIJF with TTI was performed in 51 subjects. Structured follow-up occurred at 3, 6, 12 and 24 months. Both quality of life questionnaires and functional tests were performed at all study visits. RESULTS: 84% of subjects were available for 24-month follow-up. Observed were rapid and persistent improvements in dysfunction due to pain (Oswestry Disability Index [ODI], mean 52.8 at baseline and 28.3 at 24 months, p<0.0001) and SIJ pain ratings (mean 78.5 at baseline [0-100 scale] to 21.5 at 24 months). Opioid use for SIJ pain decreased markedly from baseline. Physical function tests impaired by SIJ pain showed persistent improvements compared to baseline. There was no evidence of device breakage, migration or subsidence and few late adverse events occurred attributable to the device. CONCLUSION: In this prospective study, SIJF using 3D-printed TTI resulted in immediate, marked and persistent improvements in pain and quality of life, with improved physical function, reduced opioid use and a low rate of late device-related adverse events. LEVEL OF EVIDENCE: Level II.

Prospective Trial of Sacroiliac Joint Fusion Using 3D-Printed Triangular Titanium Implants.

BACKGROUND: Prior trials provide strong evidence supporting minimally invasive sacroiliac joint (SIJ) fusion using triangular titanium implants (TTI) for chronic SIJ dysfunction. OBJECTIVE: To assess the safety and effectiveness of SIJF using a 3D-printed TTI. METHODS: Fifty-one subjects with carefully diagnosed SIJ dysfunction underwent SIJF with 3D TTI. Subjects completed pain, disability and quality of life questionnaires at baseline and 3, 6 and 12 months postoperatively. Functional tests were performed in the clinic at each visit. Pelvic CT scans were independently evaluated for radiolucency, bridging bone and other endpoints. RESULTS: Ninety percent had 12-month follow-up. Dysfunction due to pain (Oswestry Disability Index [ODI]) decreased from 52.8 at baseline to 27.9 at 12 months (p<.0001 for change, p=.004 for non-inferiority primary hypothesis). SIJ pain scores improved from 78 preoperatively to 21 at 12-month follow-up (P<.0001). Ninety-six percent experienced an improvement of 20 points or more in VAS SIJ pain by month 12. The percentage of subjects reporting minimal difficulty performing physical activities typically impaired by back/SIJ pain improved significantly for all activities. The proportion of subjects taking opioids for SIJ pain decreased from 57% to 22%. Three physical function tests improved markedly from baseline to 1 year. Positive radiographic findings were observed, including a 70% and 77% rate of bone bridging observed at 6 and 12 months, respectively. There was no evidence of device breakage, migration or subsidence. CONCLUSION: In this prospective multicenter trial, SIJF with 3D-printed TTI markedly improved pain, disability and quality of life. Results are consistent with 3 prior prospective multicenter trials of a milled implant but suggest accelerated bony fusion with the newer implant. Physical function improved, and high rates of opioid cessation were observed. LEVEL OF EVIDENCE: Level II.

Long-Term Prospective Clinical And Radiographic Outcomes After Minimally Invasive Lateral Transiliac Sacroiliac Joint Fusion Using Triangular Titanium Implants.

BACKGROUND: Accumulating evidence supports the long-term safety and effectiveness of minimally invasive sacroiliac joint fusion (SIJF) for sacroiliac joint dysfunction. OBJECTIVE: To report 5-year clinical and radiographic follow-up in patients undergoing SIJF using triangular titanium implants (TTI). METHODS: One hundred and three subjects at 12 centers treated with SIJF using TTI in two prospective clinical trials (NCT01640353 and NCT01681004) were enrolled and followed in the current study (NCT02270203) with clinic visits at 3, 4 and 5 years. CT scans performed at 5 years were compared to prior CT scans (at 1 or 2 years) by an independent radiologist. RESULTS: Compared to baseline scores, SIJ pain scores at 5 years decreased by a mean of 54 points, disability scores (Oswestry Disability Index) decreased by 26 points, and quality of life scores (EuroQOL-5D time trade-off index) increased by 0.29 points (0-1 scale) (all p<0.0001). Satisfaction rates were high and the proportion of subjects taking opioids decreased from 77% at baseline to 41% at 5-year follow-up. Independent radiographic analysis showed a high rate (98%) of bone apposition to implants on both the sacral and iliac sides of the SI joint, with a high rate of bony bridging (87%) and a low rate of radiolucencies suggestive of loosening (5%). CONCLUSION: A 5-year follow-up showed continued excellent clinical responses in patients with SIJ pain treated with SIJF using triangular titanium implants along with a high rate (88%) of joint fusion. LEVEL OF EVIDENCE: Level II.

Minimally invasive lateral transiliac sacroiliac joint fusion using 3D-printed triangular titanium implants.

Background: Minimally invasive sacroiliac joint (SIJ) fusion (SIJF) has become an increasingly accepted surgical option for chronic SI joint dysfunction, a prevalent cause of chronic low back/buttock pain. Objective: To report clinical and functional outcomes of SIJF using 3D-printed triangular titanium implants (TTI) for patients with chronic SI joint dysfunction. Methods: A total of 28 subjects with SIJ dysfunction at 8 centers underwent SIJF with 3D TTI and had scheduled follow-up to 6 months (NCT03122899). Results: Mean preoperative SIJ pain score was 79.1 and mean preoperative Oswestry Disability Index (ODI) was 49.9. At 6 months, pain scores decreased by 51 points and ODI decreased by 23.6 points (both p<0.0001). The proportion of subjects able to perform various back/pelvis-related physical functions with minimal difficulty improved significantly for nearly all activities. Opioid use decreased and physical function, as assessed with three objective tests, improved. Conclusion: Early results from this prospective multicenter trial confirm that clinical responses to a 3D triangular titanium implant for SIJF are similar to those from prior trials, with improved physical function and decreased opioid use. Level of evidence: Level II.

Long-term prospective outcomes after minimally invasive trans-iliac sacroiliac joint fusion using triangular titanium implants.

BACKGROUND: Minimally invasive sacroiliac joint fusion (SIJF) has become an increasingly accepted surgical option for chronic sacroiliac (SI) joint dysfunction, a prevalent cause of unremitting low back/buttock pain. OBJECTIVE: The objective of this study was to report clinical and functional outcomes of SIJF using triangular titanium implants (TTI) in the treatment of chronic SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint (SIJ) disruption at 3 years postoperatively. METHODS: A total of 103 subjects with SIJ dysfunction at 12 centers were treated with TTI in two prospective clinical trials (NCT01640353 and NCT01681004) and enrolled in this long-term follow-up study (NCT02270203). Subjects were evaluated in study clinics at study start and again at 3, 4, and 5 years. RESULTS: Mean (SD) preoperative SIJ pain score was 81.5, and mean preoperative Oswestry Disability Index (ODI) was 56.3. At 3 years, mean pain SIJ pain score decreased to 26.2 (a 55-point improvement from baseline, p<0.0001). At 3 years, mean ODI was 28.2 (a 28-point improvement from baseline, p<0.0001). In all, 82% of subjects were very satisfied with the procedure at 3 years. EuroQol-5D (EQ-5D) time trade-off index improved by 0.30 points (p<0.0001). No adverse events definitely related to the study device or procedure were reported; one subject underwent revision surgery at year 3.7. SIJ pain contralateral to the originally treated side occurred in 15 subjects of whom four underwent contralateral SIJF. The proportion of subjects who were employed outside the home full- or part-time at 3 years decreased somewhat from baseline (p=0.1814), and the proportion of subjects who would have the procedure again was lower at 3 years compared to earlier time points. CONCLUSION: In long-term (3-year) follow-up, minimally invasive trans-iliac SIJF with TTI was associated with improved pain, disability, and quality of life with relatively high satisfaction rates. LEVEL OF EVIDENCE: Level II. CLINICAL RELEVANCE: SIJF with TTI.

Hemorrhage and risk of further hemorrhagic strokes following cerebral revascularization in Moyamoya disease: A review of the literature.

BACKGROUND: We sought to review the current literature with regards to future risks of hemorrhage following cerebral revascularization in Moyamoya disease (MMD). METHODS: We performed a comprehensive literature review using PubMed to inspect the available data on the risk of hemorrhage after revascularization in MMD. RESULTS: In this review, we identify the risk factors associated with hemorrhage in MMD both before and after cerebral revascularization. We included proposed pathophysiology of the hemorrhagic risk, role of the type of bypass performed, treatment options, and future needs for investigation. CONCLUSIONS: The published cases and series of MMD treatment do show a risk of hemorrhage after treatment with either direct or indirect bypass both in the immediate as well as long-term future. While there are no discernible patterns in the rate of these hemorrhages, there is Class III evidence for the predictive effect of multiple microbleeds on preoperative imaging. Also, whereas revascularization, both direct and indirect, has been shown to reduce ischemic complications from MMD, there is not an association with the risk of hemorrhage after the procedure. Further studies need to be performed to help evaluate what the risk factors are and how to counsel patients as to the long-term outlook of this disease process.

Stent-assisted coil emboilization of ruptured intracranial aneurysms: A retrospective multicenter review.

BACKGROUND: The purpose of this study is to retrospectively review our experience with stent-assisted embolization of patients with an acutely ruptured cerebral aneurysm. METHODS: Medical records and imaging were reviewed for 36 patients who underwent stent-assisted embolization of a ruptured cerebral aneurysm. RESULTS: Seventeen patients (47%) received a preprocedural loading dose of clopidogrel and five patients (14%) received an intraprocedural dose of clopidogrel. The remaining 14 patients (36%) were treated with antiplatelet therapy following the procedure. Six (17%) stent related intraprocedural thromboembolic complications were encountered; four of these resolved (one partial, three complete) following treatment with abciximab and/or heparin during the procedure. Five of the six thromboembolic events occurred in patients who were not pretreated with clopidogrel (P = 0.043). Two patients in this series (6%) had a permanent thrombotic complication resulting in mild hemiparesis in one patient, and hemianopsia in the second. No procedure related hemorrhagic complications occurred in any patient. One patient had a spontaneous parenchymal hemorrhage contralateral to the treated aneurysm discovered 10 days after treatment. Twenty-eight patients (78%) had a Glasgow Outcome Score of 4 or better at discharge. Seven of 21 patients (33%) with angiographic follow-up required further treatment of the coiled aneurysm. CONCLUSION: Stent-assisted coil embolization is an option for treatment of ruptured wide neck ruptured aneurysms and for salvage treatment during unassisted embolization of ruptured aneurysms but complications and retreatment rates are higher than for routine clipping or coiling of cerebral aneurysms. Pretreatment with clopidogrel appears effective in reducing thrombotic complications without significant increasing risk of hemorrhagic complications.

Radiation associated tumors following therapeutic cranial radiation.

BACKGROUND: A serious, albeit rare, sequel of therapeutic ionizing radiotherapy is delayed development of a new, histologically distinct neoplasm within the radiation field. METHODS: We identified 27 cases, from a 10-year period, of intracranial tumors arising after cranial irradiation. The original lesions for which cranial radiation was used for treatment included: tinea capitis (1), acute lymphoblastic leukemia (ALL; 5), sarcoma (1), scalp hemangioma (1), cranial nerve schwannoma (1) and primary (13) and metastatic (1) brain tumors, pituitary tumor (1), germinoma (1), pinealoma (1), and unknown histology (1). Dose of cranial irradiation ranged from 1800 to 6500 cGy, with a mean of 4596 cGy. Age at cranial irradiation ranged from 1 month to 43 years, with a mean of 13.4 years. RESULTS: Latency between radiotherapy and diagnosis of a radiation-induced neoplasm ranged from 4 to 47 years (mean 18.8 years). Radiation-induced tumors included: meningiomas (14), sarcomas (7), malignant astrocytomas (4), and medulloblastomas (2). Data were analyzed to evaluate possible correlations between gender, age at irradiation, dose of irradiation, latency, use of chemotherapy, and radiation-induced neoplasm histology. Significant correlations existed between age at cranial irradiation and development of either a benign neoplasm (mean age 8.5 years) versus a malignant neoplasm (mean age 20.3; P = 0.012), and development of either a meningioma (mean age 7.0 years) or a sarcoma (mean age 27.4 years; P = 0.0001). There was also a significant positive correlation between latency and development of either a meningioma (mean latency 21.8 years) or a sarcoma (mean latency 7.7 years; P = 0.001). The correlation between dose of cranial irradiation and development of either a meningioma (mean dose 4128 cGy) or a sarcoma (mean dose 5631 cGy) approached significance (P = 0.059). CONCLUSIONS: Our study is the first to show that younger patients had a longer latency period and were more likely to have lower-grade lesions (e.g. meningiomas) as a secondary neoplasm, while older patients had a shorter latency period and were more likely to have higher-grade lesions (e.g. sarcomas).

Resolution of acute hydrocephalus and migration of neurocysticercosis cyst with external ventricular drainage.

Neurocysticercosis is endemic in the developing world, but is becoming more common in the US due to immigration. A 24-year-old man presented with acute hydrocephalus and headaches, nausea, and vomiting. Head CT revealed a 3rd ventricular cyst and immunological studies were suggestive of neurocysticercosis. EVD placement resulted in migration of the cyst interiorly and superiorly with return of normal CSF flow by MRI and resolution of symptoms. Review of this condition is important given increasing incidence in the United States.

Paradoxical emboli secondary to hepatic pathology: common or coincidental?

Paradoxical cerebral emboli from cardiac and pulmonary sources are well described in the peer-reviewed literature. We outline a case with a hepatic etiology and describe diagnostic and management options. Though this paper represents the first documentation of such, we believe that transpulmonary shunting with concurrent paradoxical cerebral microemboli is more prevalent than recognized. We introduce this case report to compel practitioners to consider paradoxical emboli in selected cirrhotic patients since it can often be difficult to elicit subtle neurologic changes on clinical examination of patients with end stage liver disease.

Impairment of intracerebral arteriole dilation responses after subarachnoid hemorrhage. Laboratory investigation.

OBJECT: Cerebrovascular dysfunction after subarachnoid hemorrhage (SAH) may contribute to ischemia, but little is known about the contribution of intracerebral arterioles. In this study, the authors tested the hypothesis that SAH inhibits the vascular reactivity of intracerebral arterioles and documented the time course of this dysfunction. METHODS: Subarachnoid hemorrhage was induced using an endovascular filament model in halothane-anesthetized male Sprague-Dawley rats. Penetrating intracerebral arterioles were harvested 2, 4, 7, or 14 days postinsult, cannulated using a micropipette system that allowed luminal perfusion and control of luminal pressure, and evaluated for reactivity to vasodilator agents. RESULTS: Spontaneous tone developed in all pressurized (60 mm Hg) intracerebral arterioles harvested in this study (from 66 rats), with similar results in the sham and SAH groups. Subarachnoid hemorrhage did not affect dilation responses to acidic pH (6.8) but led to a persistent impairment of endothelium-dependent dilation responses to adenosine triphosphate (p < 0.01), as well as a transient attenuation (p < 0.05) of vascular smooth muscle-dependent dilation responses to adenosine, sodium nitroprusside, and 8-Br-cyclic guanosine monophosphate (cGMP). Impairment of NO-mediated dilation was more sustained than adenosine- and 8-Br-cGMP-induced responses (up to 7 days postinsult compared with 2 days). All smooth muscle-dependent responses returned to sham levels by 14 days after SAH. CONCLUSIONS: Subarachnoid hemorrhage led to a persistent impairment of endothelium-dependent dilation and a transient attenuation of vascular smooth muscle-dependent dilation responses to adenosine. Impairment of NO-mediated dilation occurred when the response to cGMP was intact, suggesting a change in cGMP levels rather than an alteration in intracellular mechanisms downstream from cGMP.

Ectopic glioneuronal tissue in the middle cranial fossa region. Report of four cases.

The growth of ectopic glioneuronal tissue in the middle cranial fossa region is an uncommon event, with very few cases reported in the literature. In this paper the authors document 4 cases of ectopic glioneuronal tissue in the middle cranial fossa in children and briefly describe the clinical course and pathology. All of the children presented within the first 6 months of life. Two children presented with facial masses, 1 with airway obstruction, and another with proptosis of the right eye. Each child underwent a customized surgery dependent on the location and characteristics of the harbored lesion. Ectopic glioneuronal masses in the middle cranial fossa are rare and benign congenital tumors, and affected newborns can present with airway obstruction, feeding difficulties, and facial deformity depending on the lesion location. Determining an appropriate surgical approach and strategy is a significant challenge and may involve a multidisciplinary team of craniofacial plastic surgeons, otolaryngologists, and neurosurgeons. Although these lesions share clinical and anatomical similarities, because of their histopathological heterogeneity, it is unlikely that they represent a single pathological entity. The long-term outcome in these children is still unknown and is an area for future study. The pathogenesis of these lesions also remains unknown and may be revealed in future research.

Thoracic spinal cord compression by intramedullary hamartomatous tissue in a young boy: case report.

OBJECTIVE: Spinal cord hamartomas are a rare occurrence characterized by well- differentiated mature elements located in an irregular position in the spinal cord. CLINICAL PRESENTATION: The authors present the unique case of a 12-year-old boy who originally presented to our center for treatment of a right thalamic astrocytoma. One year after his initial presentation, the child developed progressive bilateral leg weakness with decreased sensation. Spinal magnetic resonance imaging performed at this time revealed an intramedullary spinal cord lesion from T4 to T8, which was later found to be composed of hamartomatous tissue. INTERVENTION: The patient underwent bilateral T4 to T8 laminectomies with subtotal resection of the hamartomatous lesion, and his symptoms improved postoperatively. CONCLUSION: Although typically described in the literature as spinal cord hamartomas because of their histological composition, these rare hamartomatous lesions may be the result of a neurulation defect rather than true hamartomas. In patients presenting with multiple neurological conditions, as in our case, diagnosis may be more complex. For those presenting with neurological signs and symptoms, surgical treatment is essential.

Subarachnoid hemorrhage model in the rat: modification of the endovascular filament model.

The present study describes modifications to the endovascular filament model of subarachnoid hemorrhage (SAH) in rats. Specifically, we sought to improve the percentage yield of SAH, reduce mortality rates and better simulate human cerebral aneurysmal rupture. Instead of using a 4-0 prolene suture to induce SAH in the existing endovascular filament model, a hollow and flexible polyetrafluoroethylene (PTFE) tube was maneuvered into the proximal anterior cerebral artery (ACA) to ensure that advancement occurred without producing trauma to the vessels. SAH was induced by advancing a tungsten wire through this tube, perforating the ACA at the desired location. These modifications produced significant improvements over the endovascular filament model. Mortality rate declined from 46 to 19%, and SAH was produced more frequently. With the prolene suture, only 48% of our attempts produced a SAH, and unsuccessful attempts typically resulted in an acute subdural hematoma (ASDH). In contrast, the wire/tubing technique was 90% successful at inducing SAH, and led to a significant reduction of ASDH incidence from 44 to 6%. Additionally, the modified technique produced vasospasm in basilar and middle cerebral arteries post-SAH as well as pseudoaneurysms in the proximal ACA which indicated the location of vessel perforation.

Spontaneous subdural fluid collections following transection of a fatty filum terminale: case report and review of the literature.

We present the case of a 6-year-old girl who developed bilateral subdural fluid collections following transection of her fatty filum terminale. The patient presented to our emergency department 3 weeks subsequent to surgery, reporting symptoms of headache, nausea, and vomiting. The presence of bilateral subdural fluid collections was confirmed by head computerized tomography. Subdural fluid collections and hematomas have been associated with intracranial hypotension and excessive cerebrospinal fluid leakage; however, there are relatively few cases of subdural fluid collections/hematomas following spine surgery reported in the literature. To our knowledge, this is a unique description of development and resolution of subdural fluid collections following surgical transection of a fatty filum terminale.

Time-dependent alterations in functional and pharmacological arteriolar reactivity after subarachnoid hemorrhage.

BACKGROUND AND PURPOSE: Disturbances in cerebral arteriolar function, in addition to large vessel vasospasm, may be responsible for ischemia after subarachnoid hemorrhage. The purpose of this study was to test the hypothesis that subarachnoid hemorrhage alters cerebral microvascular reactivity. METHODS: An endovascular filament model was used to induce subarachnoid hemorrhage in halothane-anesthetized male Sprague-Dawley rats. We evaluated pial arteriolar responses to sciatic nerve stimulation, topically applied vasoactive agents (adenosine or sodium nitroprusside), and CO(2) inhalation in rats subjected to subarachnoid hemorrhage at 1 to 5 days after insult. RESULTS: In sham-operated rats, sciatic nerve stimulation evoked a 23.5+/-1.8% increase in arteriolar diameter, which was significantly attenuated to 13.7+/-0.9%, 12.8+/-2.5%, and 18.8+/-2.9% at 24, 48, and 72 hours after subarachnoid hemorrhage, respectively (P<0.05; n> or =7). At 96 and 120 hours after subarachnoid hemorrhage, sciatic nerve stimulation-induced dilation recovered to sham levels. Somatosensory-evoked potentials were unaltered by subarachnoid hemorrhage. Pial vasodilatation to adenosine (10 micromol/L) and sodium nitroprusside (1 micromol/L) were significantly impaired, by 47% and 41%, respectively, at 48 hours after subarachnoid hemorrhage (P<0.05; n=7). In contrast, CO(2) reactivity was unaffected by subarachnoid hemorrhage. CONCLUSIONS: Pial arteriolar responses to cortical activation may be decreased in the initial 2 to 3 days after experimental subarachnoid hemorrhage.

Spinal cord pilocytic astrocytoma with leptomeningeal dissemination to the brain. Case report and review of the literature.

Leptomeningeal dissemination of low-grade spinal cord gliomas is an uncommon event. The authors report a unique case of leptomeningeal dissemination of a spinal cord pilocytic astrocytoma (PCA) to the intracranial cerebral subarachnoid spaces in a child. A 2-year-old boy presented with a loss of balance and the inability to walk or stand. An intradural intramedullary spinal cord tumor was identified, and the lesion was subtotally resected and diagnosed by the pathology department to be a PCA. Subsequently, the patient had recurrences of the intradural intramedullary tumor at 6 months and 2 years after his original presentation. He underwent a repeated resection of the recurrent tumor and fenestration of an associated syrinx on both occasions. The pathological characteristics of the reresected tumor remained consistent with those of a PCA. Postoperative imaging after his last surgery revealed diffuse intracranial leptomeningeal dissemination into the cisternal space surrounding the midbrain, the suprasellar region, and the internal auditory canal, as well as nodular subarachnoid disease in the upper cervical region. The patient then underwent chemotherapy, and total spine magnetic resonance (MR) imaging 2 months later demonstrated stability in the size of the spinal cord tumor and a decrease in the associated syrinx. However, an MR image of the head demonstrated two new areas of supratentorial subarachnoid leptomeningeal spread of the primary spinal cord tumor at the 2-month follow-up examination. At the 6-month follow-up examination, MR imaging of the head and spine demonstrated stable metastatic disease. This case illustrates a unique instance of supratentorial leptomeningeal dissemination of an intramedullary spinal cord PCA in a child.

Acquired chiari malformation type I associated with a fatty terminal filum. Case report.

The authors report the case of a 3-year-old girl with a Chiari malformation Type I (CM-I) and concomitant fatty terminal filum. This child was examined prior to the onset of CM-I as well as after, and the authors present magnetic resonance (MR) images documenting that the malformation was acquired as the child grew in height. This case contributes to the literature describing an acquired CM-I associated with a fatty filum and is the first published account to include MR imaging obtained before and after the onset of the malformation.