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1.
Acta Neurochir Suppl ; 130: 41-45, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37548722

RESUMO

A 52-year-old man was admitted to our hospital with symptoms of raised intracranial pressure and cerebellar dysfunction caused by a medium-sized (4 cm in diameter) tentorial meningioma with an infratentorial extension. Preoperative magnetic resonance imaging showed that the tumor indented and possibly partially invaded the adjacent junction of the nondominant transverse and sigmoid sinuses. The contralateral dominant transverse sinus was fully patent. Total surgical removal of the lesion was done through the left retrosigmoid approach. During dissection of the meningioma, some bleeding from the venous sinus was noted, which was easily controlled by packing with hemostatic materials. The initial postoperative period was unremarkable, but approximately 48 h after surgery, acute clinical deterioration caused by hemorrhagic venous infarction of the left cerebellar hemisphere and brain stem developed and necessitated urgent reoperation for the evacuation of hematoma and brain decompression. Thereafter, the patient remained in a prolonged coma with a severe neurological deficit. After several years of extensive neurorehabilitation, he was able to walk with support but had a tracheostomy, required a feeding tube, and voided with a urinary catheter. Such a catastrophic outcome after an apparently trivial nondominant transverse sinus injury during resection of a tentorial meningioma raises the question whether reconstruction of the sinus wall with preservation of its patency might have prevented this complication in our patient.


Assuntos
Neoplasias Meníngeas , Meningioma , Masculino , Humanos , Pessoa de Meia-Idade , Meningioma/diagnóstico por imagem , Meningioma/cirurgia , Dura-Máter/patologia , Dura-Máter/cirurgia , Cavidades Cranianas/patologia , Cavidades Cranianas/cirurgia , Imageamento por Ressonância Magnética , Neoplasias Meníngeas/diagnóstico por imagem , Neoplasias Meníngeas/cirurgia
3.
Neurol India ; 70(3): 1176-1179, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35864659

RESUMO

Background: Symptomatic spinal epidural veins (SEV) are a rare cause of neurologic dysfunction. Treatment is centered upon addressing the underlying venous pathology to relieve mechanical compression of the neurologic structures. However, open surgical ligation is often associated with considerable blood loss. Objective: We discuss a unique case of a large symptomatic epidural venous varix and potential treatment strategy. Methods and Materials: A 15-year-old female presented with a 1-year history of left L5 radicular pain and weakness. Lumbar MRI demonstrated a central L5/S1 herniated disc and a large extradural anomalous SEV compressing the exiting left L5 nerve root at the L5/S1 neuroformina. The SEV was treated using a transvenous liquid embolic agent providing symptomatic relief. At 16-months follow-up, she reported recurrent symptoms. She ultimately underwent a left L5/S1 MIS decompression without complication. Conclusion: Transvenous liquid embolization of large symptomatic SEV may provide temporary neurologic relief and decrease morbidity associated with open surgical treatment options.


Assuntos
Embolização Terapêutica , Deslocamento do Disco Intervertebral , Radiculopatia , Varizes , Adolescente , Embolização Terapêutica/efeitos adversos , Espaço Epidural , Feminino , Humanos , Deslocamento do Disco Intervertebral/diagnóstico , Deslocamento do Disco Intervertebral/cirurgia , Vértebras Lombares/patologia , Vértebras Lombares/cirurgia , Radiculopatia/diagnóstico , Radiculopatia/etiologia , Radiculopatia/terapia , Varizes/complicações , Varizes/diagnóstico , Varizes/terapia
4.
Neurol India ; 69(6): 1737-1742, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34979678

RESUMO

BACKGROUND: Despite recommendations and guidelines, surgical antibiotic prophylaxis protocol for neurosurgical cases is not uniformly followed. OBJECTIVE: To report trends in the use of prophylactic antibiotics by Indian neurosurgeons for non-trauma neurosurgical cases. MATERIALS AND METHODS: An email survey consisting of 17 questions was sent in 2018 to 2,175 surgical members with a registered email in the Neurological Society of India (NSI) registry. Three reminders were sent at 3-month intervals. The results were analyzed for the number, type, and duration of antibiotic use for different surgical procedures. The differences in the antibiotic policy in different practice settings were also studied. RESULTS: The response rate was less than 5% (103 responses). Almost all (98.1%) surgeons used prophylactic antibiotics. A single antibiotic was most used for cranial surgeries (85%) and least for spine surgeries with instrumentation (64%) (P = 0.001). One dose or 1 day of antibiotics was used by the least number of responders (29%) for spinal instrumentation surgeries and the most responders (66.7%) for spinal surgery without instrumentation (P < 0.0001). Surgeons working in corporate teaching hospitals or non-teaching hospitals were more likely to use antibiotics for longer duration than surgeons working in government/trust teaching hospitals. CONCLUSIONS: Substantial numbers of surgeons use prophylactic antibiotics for more than 1 day with a higher proportion of surgeons working in corporate teaching and non-teaching hospitals pursuing such a policy.


Assuntos
Antibacterianos , Neurocirurgiões , Antibacterianos/uso terapêutico , Antibioticoprofilaxia , Humanos , Procedimentos Neurocirúrgicos , Inquéritos e Questionários
5.
Neurol India ; 68(6): 1351-1360, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33342868

RESUMO

BACKGROUND: To document the outcomes and quality of follow-up compliance after planned subtotal, near-total and gross-total resection (STR, NTR, and GTR) of vestibular schwannomas (VSs). METHODS: This is a retrospective study of 294 consecutive patients, who underwent excision of a previously untreated VS, between 2005 and 2015. Outcomes including long-term tumor control, facial nerve outcomes, and compliance with follow-up advice were studied. RESULTS: The mean diameter of the tumors was 4.2 cm (±0.8 cm; range: 2.2-7.5 cm). Less than total excision was performed in 55 cases (18.7%), of which NTR was performed in 65% of the cases (n = 36) and STR in the remaining 35%. In the GTR group, 29.3% of patients had a good facial outcome (House and Brackmann [HB] grades 1-3) whereas 81.8% of patients undergoing NTR/STR had a good facial outcome. Follow-up was available in 94.5% of patients undergoing NTR/STR whereas only 69.5% of patients undergoing GTR could be followed up. Only 61.8% of the patients who had NTR/STR were compliant with our follow-up advice and were on either regular radiological surveillance or underwent stereotactic radiosurgery (SRS) as advised. In this group of patients, those with larger tumors and those who underwent a more extensive resection of their tumor were less likely to be compliant with follow-up advice (P = 0.043 and 0.007, respectively). Among patients who had GTR, nine patients (3.7%) were detected to have tumor recurrence at a mean interval of 5.5 years after surgery. CONCLUSION: "Incomplete" microsurgical excision followed by SRS is an effective strategy that fulfills the twin objectives of preservation of function and long-term tumor control. Considering follow-up attrition due to various causes, upfront SRS at the first follow-up visit-even for a small residue-may be a prudent strategy in selected patients.


Assuntos
Neuroma Acústico , Radiocirurgia , Seguimentos , Humanos , Recidiva Local de Neoplasia , Neuroma Acústico/cirurgia , Procedimentos Neurocirúrgicos , Estudos Retrospectivos , Resultado do Tratamento
7.
J Neurosurg ; 132(3): 884-894, 2019 Feb 22.
Artigo em Inglês | MEDLINE | ID: mdl-30797190

RESUMO

OBJECTIVE: The evolution of microsurgical and endoscopic techniques has allowed the development of less invasive transcranial approaches. The authors describe a purely endoscopic transpterional port craniotomy to access lesions involving the cavernous sinus and the anterolateral skull base. METHODS: Through single- or dual-port incisions and with direct endoscopic visualization, the authors performed an endoscopic transpterional port approach (ETPA) using a 4-mm straight endoscope in 8 sides of 4 formalin-fixed cadaveric heads injected with colored latex. A main working port incision is made just below the superior temporal line and behind the hairline. An optional 0.5- to 1-cm second skin port incision is made on the lateral supraorbital region, allowing multiangle endoscopic visualization and maneuverability. A 1.5- to 2-cm craniotomy centered over the pterion is done through the main port, which allows an extradural exposure of the cavernous sinus region and extra/intradural exposure of the frontal and temporal cranial fossae. The authors present a pilot surgical series of 17 ETPA procedures and analyze the surgical indications and clinical outcomes retrospectively. RESULTS: The initial stage of this work on cadavers provided familiarity with the technique, standardized its steps, and showed its anatomical limits. The clinical ETPA was applied to gain access into the cavernous sinus, as well as for aneurysm clipping and meningioma resection. Overall, perioperative complications occurred in 1 patient (6%), there was no mortality, and at last follow-up all patients had a modified Rankin Scale score of 0 or 1. CONCLUSIONS: The ETPA provides a less invasive, focused, and direct route to the cavernous sinus, and to the frontal and temporal cranial fossae, and it is feasible in clinical practice for selected indications with good results.

8.
Oper Neurosurg (Hagerstown) ; 17(2): 132-142, 2019 08 01.
Artigo em Inglês | MEDLINE | ID: mdl-30768130

RESUMO

BACKGROUND: The role of expanded endonasal endoscopic surgery for primary and recurrent craniopharyngioma is not yet fully established. OBJECTIVE: To report and evaluate our experience with the endoscopic endonasal approach (EEA) for the resection of primary and recurrent craniopharyngiomas. METHODS: This is a retrospective cohort analysis of 43 consecutive EEA procedures in 40 patients operated from September 2006 to February 2012 for suprasellar craniopharyngiomas. In 21 patients (48.8%) the disease was recurrent. We have assessed the surgical results, visual, endocrinological, and functional outcomes and resection rates in this patient cohort. RESULTS: At presentation, 31 (72.1%) patients had visual deficits, 15 patients (34.9%) complained of headaches, 25 patients (58.1%) had anterior pituitary insufficiency, and 14 (32.5%) had diabetes insipidus. Total resection was achieved in 44.2% surgeries, of which 77.3% were in primary lesions and 9.5% in recurrent lesions (P < .001). Vision improved in 92.6% patients and worsened in 2.3%. Complications other than vision were encountered in 25.6% including 9/43 cerebrospinal fluid leak, 2/43 meningitis. A total of 51.9% of patients with preoperative residual anterior pituitary function had new anterior pituitary deficiencies and 42.8% had new diabetes insipidus. There was no mortality. Six patients (14%) had recurrence of disease during the follow-up period (mean 56.8 mo), 5 of which required repeat surgery. CONCLUSION: The EEA can be integrated in the overall management of both primary and recurrent craniopharyngiomas with good results; however, in our series recurrent surgery was associated with significantly lower rates of gross total resection.


Assuntos
Craniofaringioma/cirurgia , Neuroendoscopia/métodos , Neoplasias Hipofisárias/cirurgia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Criança , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recidiva Local de Neoplasia/cirurgia , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
9.
J Neurosurg Sci ; 63(2): 200-215, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-27901326

RESUMO

INTRODUCTION: With the advent of skull base endoscopy, tuberculum sellae meningiomas (TSMs) are currently operated both from the traditional transcranial (TC) route as well as the extended endonasal endoscopic trasns-sphenoidal approach (EETS). The aim of this study was to conduct a systematic review of TSMs excised via the TC route in the modern era when the EETS excision is gaining popularity. EVIDENCE ACQUISITION: We performed a systematic review in the medical literature following the PRISMA guidelines. A medical librarian retrieved a list of 3443 articles published from 2006-2016 from the Medline, Embase and Cochrane Central databases. Two of the authors independently screened for titles and abstracts and excluded 3340 of them. We reviewed the full text of the remaining 103 articles and included in our analysis 31 that met the following inclusion criteria: 1) 5 or more cases reported; and 2) report of the extent of resection, visual outcomes and complications specifically for TSMs were documented. EVIDENCE SYNTHESIS: Thirty-one articles were selected for this systematic review with a total number of 983 patients with TSM. The mean age was 54.1±4.6 years, 75% of them being female. The follow-up was 43.9±20.7 months. The mean tumor diameter was 27.8±4.9 mm. Gross total resection was achieved in 84% while subtotal or near total resection was 14%. Vision improved, worsened and remained unchanged in 65.5%, 10.4%, and 24.7% respectively. The CSF leak rate was 3.4%. Transient or permanent pituitary dysfunction was reported in 6.9% of patients. There was a vascular injury in 5.1% of the patients with the majority (4.3%) being symptomatic. The recurrence rate was 3.8% and mortality 1.1%. CONCLUSIONS: In the past decade, the ETTS excision of TSMs has gained popularity and in some centers has become the approach of choice. However the TC route still remains the most common approach for most TSMs meningiomas and for the majority of neurosurgeons. The evolution of transcranial surgery including the use of minimally invasive techniques, such as endoscope-assisted transcranial resection are associated with relatively high resection rates and improved visual outcomes with low morbidity and mortality. A direct comparison with TS approaches was not done for the purpose of this review analysis. Given the limited availability and heterogeneity of comparative observational studies, a meta-analysis was deemed inappropriate.


Assuntos
Craniotomia/métodos , Neoplasias Meníngeas/cirurgia , Meningioma/cirurgia , Neoplasias da Base do Crânio/cirurgia , Adulto , Idoso , Craniotomia/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Neuroendoscopia/métodos
10.
J Neurosci Rural Pract ; 9(4): 574-577, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30271052

RESUMO

Sacroiliac fusion and instrumentation extension for correction of failed lumbosacral fusions traditionally requires a long revision surgery. Reopening of the prior surgical incision to expose the prior instrumentation requires a large incision with increased blood loss, increased operative time, increased risk of infection, and longer hospitalization times. We describe the first case series using a minimally invasive surgical sacroiliac screw technique for extension of a prior fusion to the pelvis. Using two small 3-cm paramedian incisions on each side, we were able to obtain autologous iliac crest bone graft, place the sacroiliac screw minimally invasive, perform an arthrodesis, and connect the prior surgical hardware to the sacroiliac screw safely. A detailed review of surgical technique, clinical cases, and brief review of the literature is discussed.

11.
Neurol India ; 66(3): 755-762, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29766939

RESUMO

BACKGROUND: The incidence of adjacent segment disease (ASD) after lumbar spine surgery is a condition that has become increasingly common as the rate of lumbar spine surgery continues to rise. Minimally invasive techniques continue to be refined and offer an opportunity to treat ASD with minimal tissue disruption, lower blood loss, a shorter hospital stay, and decreased morbidity. The aim of this report is to describe the various minimally invasive options for ASD with a comprehensive review of the existing literature. MATERIALS AND METHODS: A retrospective chart review of patients undergoing minimally invasive spine surgery (MIS) for ASD of the lumbar spine was conducted. Four basic techniques and their modifications were identified to address ASD. Illustrative cases, surgical techniques, and post-surgical outcomes are described. RESULTS: Four MIS techniques were identified as common surgical methods to correct ASD. (1) Non-instrumented discectomy, foraminotomy, or decompression, (2) anterior lumbar interbody fusion (ALIF), (3) transforaminal lumbar interbody fusion (TLIF), and (4) lateral lumbar interbody fusion (LLIF) were found to be MIS techniques that address ASD. ALIF and LLIF provide indirect decompression of the neural foramina, while TLIF provides direct decompression. The addition and removal of screws and rods can be combined with any of these techniques. CONCLUSIONS: MIS techniques provide decompression of the neural elements, stabilization, and, potentially, fusion for patients with ASD. These illustrated cases and the review of MIS surgical techniques can provide a comprehensive framework for addressing ASD.


Assuntos
Vértebras Lombares/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Procedimentos Ortopédicos/efeitos adversos , Procedimentos Ortopédicos/métodos , Complicações Pós-Operatórias/cirurgia , Idoso , Feminino , Humanos , Vértebras Lombares/patologia , Masculino , Pessoa de Meia-Idade , Complicações Pós-Operatórias/etiologia , Estudos Retrospectivos
13.
J Neurosurg Spine ; 28(4): 401-405, 2018 04.
Artigo em Inglês | MEDLINE | ID: mdl-29372863

RESUMO

Ossification of the ligament flavum in the thoracic spine is an uncommon radiological finding in the Western population but can present with back pain, varying degrees of myelopathy, and even paraplegia on occasion. The authors here present the case of a 50-year-old woman with a history of progressive back pain and symptoms of spontaneous intracranial hypotension who was found to have an ossified ligamentum flavum of the thoracic spine resulting in a dural erosion cerebrospinal fluid leak. Surgery involved removal of the ossified ligament flavum at T10-11, facetectomy, ligation of the nerve root, and primary closure of the dura, which resulted in complete resolution of the patient's symptoms. Radiological, clinical, and intraoperative findings are discussed to assist surgeons with an accurate diagnosis and treatment in the setting of this unusual presentation.


Assuntos
Hipotensão Intracraniana/cirurgia , Ligamento Amarelo/cirurgia , Ossificação Heterotópica/cirurgia , Doenças da Medula Espinal/cirurgia , Descompressão Cirúrgica/métodos , Feminino , Humanos , Hipotensão Intracraniana/diagnóstico , Laminectomia/métodos , Pessoa de Meia-Idade , Ossificação Heterotópica/diagnóstico , Osteogênese/fisiologia , Resultado do Tratamento
15.
J Neurosurg ; 128(5): 1403-1409, 2018 05.
Artigo em Inglês | MEDLINE | ID: mdl-28731398

RESUMO

OBJECTIVE Multiple meningiomas account for 1%-10% of meningiomas. This study describes epidemiological aspects of the disease and its management, which is more challenging than for single tumors. METHODS A consecutive series of adult patients with ≥ 2 spatially separated meningiomas was reviewed. Patients with neurofibromatosis Type 2 were excluded. The authors collected clinical, imaging, histological, and treatment data to obtain information on epidemiology, management options, and outcomes of active treatment and surveillance. RESULTS A total of 133 consecutive patients were included over 25 years, with a total of 395 synchronous and 53 metachronous meningiomas, and a median of 2 tumors per patient. One hundred six patients had sporadic disease, 26 had radiation-induced disease, and 1 had familial meningiomatosis. At presentation, half of the patients were asymptomatic. In terms of their maximum cross-sectional diameter, the tumors were small (≤ 2 cm) in 67% and large (> 4 cm) in 11% of the meningiomas. Fifty-four patients had upfront treatment, and 31 had delayed treatment after an observation period (mean 4 years). One in 4 patients had ≥ 2 meningiomas treated. Overall, 64% of patients had treatment for 142 tumors-67 with surgery and 18 with radiotherapy alone. The mean follow-up was 7 years, with 13% of treated patients receiving salvage therapy. Approximately 1 in 4 patients who underwent surgery had ≥ 1 WHO Grade II or III meningioma. Meningiomas of different histological subtypes and grades in the same patient were not uncommon. CONCLUSIONS Multiple meningiomas are often asymptomatic, probably because the majority are small and a significant proportion are induced by radiation. Approximately two-thirds of patients with multiple meningiomas require therapy, but only one-third of all meningiomas need active treatment. The authors recommend surveillance for stable and asymptomatic meningiomas and therapy for those that are symptomatic or growing.


Assuntos
Neoplasias Meníngeas/terapia , Meningioma/terapia , Neoplasias Primárias Múltiplas/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Masculino , Neoplasias Meníngeas/patologia , Meningioma/patologia , Pessoa de Meia-Idade , Neoplasias Primárias Múltiplas/patologia , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
16.
J Craniovertebr Junction Spine ; 8(3): 288-290, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29021685

RESUMO

Idiopathic spinal cord herniation is a rare and often missed cause of thoracic myelopathy. The clinical presentation and radiological appearance is inconsistent and commonly confused with a dorsal arachnoid cyst and often is a misdiagnosed entity. While ventral spinal cord herniation through a dural defect has been previously described, intravertebral herniation is a distinct entity and extremely rare. We present the case of a 70-year old man with idiopathic thoracic transdural intravertebral spinal cord herniation and discuss the clinico-radiological presentation, pathophysiology and operative management along with a review the literature of this unusual entity.

18.
J Craniovertebr Junction Spine ; 8(2): 119-126, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28694595

RESUMO

AIM: This study aimed to describe the application of minimally invasive surgery (MIS) in separation surgery combined with postoperative stereotactic body radiation therapy (SBRT) in patients with symptomatic metastatic epidural spinal disease. METHODS: Three techniques are described: (1) MIS posterior separation surgery alone, (2) MIS posterolateral separation surgery with percutaneous pedicle screw placement, and (3) MIS lateral corpectomy with percutaneous pedicle screw placement. Seven representative cases are presented in which the above techniques were applied and after which postoperative SBRT was performed. RESULTS: The seven representative patients (3 male, 4 female) had a mean age of 54 years (range, 46-62 years). Two patients had a primary diagnosis of cholangiocarcinoma and in one patient each a diagnosis of breast, renal, lung adenocarcinoma, melanoma, and urothelial squamous cell carcinoma as their primary tumor. All patients had additional multiorgan disease apart from the metastatic spine involvement. Three patients underwent operations in the lumbar spine, two in the thoracic spine, and one in each of the thoraco-lumbar and lumbo-sacral spine. The average operating time was 149 ± 60.3 min (range, 90-240 min). The mean estimated blood loss was 188.8 cc. The mean length of stay in the hospital was 4 days (range, 3-7 days). There were no surgical complications. All patients received postoperative SBRT (typically 24 Gy in 3 fractions) at a mean of 43.2 days after surgery (range, 30-83). CONCLUSIONS: Early reports such as this suggest that MIS techniques can be successfully and safely applied in accomplishing "separation surgery" with adjuvant SBRT in the management of metastatic spinal disease. The potential advantages conferred by MIS techniques such as shortened hospital stay, decreased blood loss, reduced perioperative complications, and earlier initiation of adjuvant radiation are highly desirable in the treatment of this challenging patient population.

19.
Artigo em Inglês | MEDLINE | ID: mdl-28250635

RESUMO

BACKGROUND: Diagnostic yields for spondylodiscitis from CT guided biopsy is low. In the recent years, minimally invasive surgery (MIS) has shown to have a low morbidity and faster recovery. For spinal infections, MIS surgery may offer an opportunity for early pain control while obtaining a higher diagnostic yield than CT-guided biopsies. The aim of this study was to review our patients who underwent MIS surgery for spinal infection and report outcomes. METHODS: A retrospective review of seven patients who underwent MIS decompression and/or discectomy in the setting of discitis, osteomyelitis, spondylodiscitis, and/or an epidural abscess was identified. Patient data including symptoms, visual analog score (VAS), surgical approach, antibiotic regimen, and postoperative outcomes were obtained. RESULTS: Of the 7 patients, 5 patients had lumbar infections and two had thoracic infections. All seven patients improved in VAS immediately after surgery and at discharge. The average VAS improved by 4.4 ± 1.9 points. An organism was obtained in 6 of the 7 (85%) patients by the operative cultures. All patients made an excellent clinical recovery without the need for further spine surgery. All patients who received postoperative imaging on follow-up showed complete resolution or dramatically improved magnetic resonance imaging changes. The follow-up ranged from 2 to 9 months. CONCLUSIONS: MIS surgery provides an opportunity for early pain relief in patients with discitis, osteomyelitis, spondylodiscitis, and/or epidural abscess by directly addressing the primary cause of pain. MIS surgery for discitis provides a higher diagnostic yield to direct antibiotic treatment. MIS surgery results in good long-term recovery.

20.
Neurosurg Focus ; 42(2): E2, 2017 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-28142245

RESUMO

OBJECTIVE The aim of this paper was to comprehensively review each of the Food and Drug Administration (FDA)-approved labels of 7 total cervical disc replacements, assess the exact methodology in which the trial was conducted, and provide a broad comparison of these devices to allow each surgeon to determine which disc best suits his or her specific treatment goals based on the specific labels and not the studies published. METHODS The FDA-approved labels for each of the 7 artificial discs were obtained from the official FDA website. These labels were meticulously compared with regard to the statistical analysis performed, the safety and efficacy data, and the randomized controlled trial that each artificial disc was involved in to obtain the FDA approval for the product or device. Both single-level and 2-level approvals were examined, and primary and secondary end points were assessed. RESULTS In the single-level group, 4 of the 7 artificial discs-Prestige LP, Prestige ST, Bryan, and Secure-C-showed superiority in overall success. Prestige ST showed superiority in 3 of 4 outcome measures (neurological success, revision surgery, and overall success), while the other aforementioned discs showed superiority in 2 or fewer measures (Prestige LP, neurological and overall success; Bryan, Neck Disability Index [NDI] and overall success; Secure-C, revision surgery and overall success; Pro-Disc C, revision surgery). The PCM and Mobi-C discs demonstrated noninferiority across all outcome measures. In the 2-level group, Prestige LP and Mobi-C demonstrated superiority in 3 outcome measures (NDI, secondary surgery, and overall success) but not neurological success. CONCLUSIONS This paper provides a comprehensive analysis of 7 currently approved and distributed artificial discs in the United States. It compares specific outcome measures of these devices against those following the standard of care, which is anterior cervical discectomy and fusion. This information will provide surgeons the opportunity to easily answer patients' questions and remain knowledgeable when discussing devices with manufacturers.


Assuntos
Vértebras Cervicais/cirurgia , Doenças da Coluna Vertebral/cirurgia , Substituição Total de Disco/instrumentação , Substituição Total de Disco/métodos , Humanos , Estados Unidos , United States Food and Drug Administration
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