Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Resultados 1 - 17 de 17
Filtrar
1.
Cureus ; 15(6): e40195, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-37325689

RESUMEN

BACKGROUND: Reherniation rates following lumbar discectomy are low for most patients; however, patients with a large defect in the annulus fibrosis have a significantly higher risk of recurrence. Previous results from a randomized controlled trial (RCT) demonstrated that the implantation of a bone-anchored annular closure device (ACD) during discectomy surgery lowered the risk of symptomatic reherniation and reoperation over one year with fewer serious adverse events (SAEs) compared to discectomy alone. OBJECTIVE: The objective of this prospective, post-market, historically controlled study was to evaluate the use of an ACD during discectomy, and to confirm the results of the RCT that was used to establish regulatory approval in the United States. METHODS: In this post-market study, all patients (N = 55) received discectomy surgery with a bone-anchored ACD. The comparison population was patients enrolled in the RCT study who had discectomy with an ACD (N = 262) or discectomy alone (N = 272). All other eligibility criteria, surgical technique, device characteristics, and follow-up methodology were comparable between studies. Endpoints included rate of symptomatic reherniation or reoperation, SAEs, and patient-reported measures of disability, pain, and quality of life. RESULTS: Fifty-five patients received ACD implants at 12 sites between May 2020 and February 2021. In the previous RCT, 272 control patients had discectomy surgery alone (RCT-Control), and 262 patients had discectomy surgery with an ACD implant (RCT-ACD). Baseline characteristics across groups were typical of the overall population undergoing lumbar discectomy. The proportion of patients who experienced reherniation and/or reoperation was significantly lower in the ACD group compared to RCT-ACD and RCT-Control groups (p < 0.05). In the ACD study, the one-year rate of symptomatic reherniation was 3.7%, compared to 8.5% in the RCT-ACD group and 17.0% in the RCT-Control group. In the ACD group, the risk of reoperation was 5.5%, compared to 6.5% in the RCT-ACD group and 12.5% in the RCT-Control group. There were no device-related SAEs or device integrity failures in the ACD, and there were clinically meaningful improvements in patient-reported measures of disability, pain, and quality of life. CONCLUSION: In this post-market study of bone-anchored ACD in patients with large annular defects, rates of symptomatic reherniation, reoperation, and SAEs were all low. Compared to the RCT, the post-market ACD study demonstrated lower rates of reherniation and/or reoperation and measures of back pain one-year post-surgery.

2.
Cureus ; 13(7): e16528, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-34430138

RESUMEN

It is imperative to thoroughly evaluate the safety, effectiveness, and cost-utility of a new medical device prior to the widespread adoption of the technology. Health technology assessment (HTA) is a systematic evaluation of the benefits and harms of a health technology that aims to inform healthcare policy decisions, improve utilization of cost-effective new technologies, and prevent the adoption of devices with harmful or doubtful value for the health system. Even though dozens of organizations perform HTAs, there is no universally accepted criterion for conducting, reporting, and deriving conclusions from an HTA. Thus, there are considerable discrepancies in the methodologies among HTAs such that the same device with the same underlying clinical evidence is often endorsed by one agency but not another, leading to inconsistencies in healthcare coverage policy decisions. Here, we propose a more simplified and unified approach for summarizing clinical effectiveness and safety outcomes for HTAs. We developed a short, semi-quantitative scoring tool that can be used to provide an overall evaluation of evidence strength in HTAs consisting of five categories: (a) the number of randomized controlled trials (RCTs) that have been performed using the technology, (b) the risk of bias among RCTs, (c) the effect size observed for the key effectiveness outcome, (d) the effect size observed for the key safety outcome, and (e) the generalizability of outcomes observed in RCTs to those observed in real-world clinical use. Utilization of this simplified semi-quantitative framework may simplify the HTA process and improve the consistency of the resulting recommendations.

3.
Int J Spine Surg ; 15(4): 633-644, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34281951

RESUMEN

BACKGROUND: Many early cervical total disc replacements (TDRs) produced motion through a ball-and-socket action, with metal endplates articulating with a plastic core. Polyetheretherketone (PEEK) is used increasingly for spinal implants due to its mechanical properties and lack of artifacts on imaging. A TDR was designed with titanium-coated PEEK endplates and a ceramic core. The purpose of this study was to compare this TDR with anterior cervical discectomy and fusion (ACDF) to treat single-level cervical disc degeneration. METHODS: This was a prospective, nonrandomized, historically controlled, multicenter US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) trial. Patients received the PEEK-on-ceramic Simplify® Cervical Artificial Disc (n = 150). The historic control group included 117 propensity-matched ACDF patients from an earlier IDE trial. The primary outcome was a composite success classification at the 24-month follow-up. Outcome measures included the Neck Disability Index (NDI), neurological status, adverse events, subsequent surgery, a visual analog scale assessing neck and arm pain, and the Dysphagia Handicap Index. Radiographic assessment included flexion/extension range of motion and heterotopic ossification. Facet joints were assessed at 24 months using MRI. RESULTS: The success rate was significantly greater in the TDR group vs the ACDF group (93.0% vs 73.6%; P < .001). Mean NDI, neck pain, and arm pain scores improved significantly in both groups at all follow-up points. Mean NDI scores in the TDR group were significantly lower than ACDF scores at all follow-up points. There were no significant differences in the rates of serious adverse events. The range of motion of the TDR level had increased significantly by 3 months and remained so throughout follow-up. Facet joint assessment by MRI in the TDR group showed little change from preoperation. CONCLUSIONS: The TDR had an acceptable safety profile and a significantly greater composite success rate than ACDF. These results support that the PEEK-on-ceramic TDR is a viable alternative to ACDF for single-level symptomatic disc degeneration. CLINICAL RELEVANCE: This study found that the PEEK-on-ceramic TDR is a viable treatment for symptoms related to cervical disc degeneration and offers similar or superior outcomes compared with fusion. LEVEL OF EVIDENCE: 2.

4.
Cureus ; 13(12): e20274, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-35018268

RESUMEN

Background Patients with large defects in the annulus fibrosus following lumbar discectomy have high rates of symptomatic reherniation and reoperation. An FDA randomized controlled trial (RCT) with a bone-anchored device (Barricaid, Intrinsic Therapeutics, Woburn, MA) that occludes the annular defect reported significantly lower risk of symptomatic reherniation and reoperation compared to patients receiving discectomy only. However, results of the Barricaid device in real-world use remain limited.  Methods This was a post-market study to determine the real-world outcomes of the Barricaid device when used in addition to primary lumbar discectomy in patients with large annular defects. Main outcomes included leg pain severity, Oswestry Disability Index (ODI), adverse events, symptomatic reherniation, and reoperation. Imaging studies were read by an independent imaging core laboratory. This paper reports the initial three-month primary endpoint results from the trial; one-year patient follow-up is ongoing. Results Among 55 patients (mean age 41±13 years, 60% male), the mean percent reduction in leg pain severity was 92%, and the mean percent reduction in ODI score was 79%. The three-month rate of symptomatic reherniation was 3.6% and the rate of reoperation was 1.8%. The serious adverse event rate was 5.5%; no device migrations or fractures were observed.  Conclusion Among patients with large annular defects following lumbar discectomy treated with the Barricaid device in real-world conditions, early results demonstrated clinically meaningful improvements in patient symptoms and low rates of symptomatic reherniation, reoperation, and complications, which were comparable to those observed with the device in an FDA-regulated trial.

5.
Neurocrit Care ; 13(2): 169-75, 2010 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-20625852

RESUMEN

BACKGROUND: Neurosurgical trainees regularly encounter critical care situations. Traditionally, education was accomplished through lecture and experience. Increasingly, human patient simulators (HPS) are employed, allowing trainees to sharpen skills in a safe and realistic environment. We describe our experience using HPS in neurosurgical training. METHODS: We developed a critical care training program for residents and medical students using HPS. We used a hi-fidelity, lifelike Human Patient Simulator™ (HPS™) produced by Medical Education Technologies, Inc.™ to simulate realistic scenarios for trainee education. Topics included spinal shock, closed head injury, and cerebral vasospasm. A three-way evaluation model was employed to test validity, including pre- and post-exercise testing, survey feedback, and videotaped replay. The simulation exercises were conducted by a neuro-critical care attending, a senior neurosurgical resident, and a HPS technician. RESULTS: We currently have 29 participants. On a 20-point critical care multiple-choice exam for these participants, average improvement has been 4.5 points or 25%. In subgroup analysis, average improvement was 4.75 points (24%) amongst neurosurgery residents, 3.07 points (18%) amongst neurology residents, 7 points (38%) amongst general surgery residents, and 7 points (38%) amongst senior medical students. Post-exercise evaluations were overwhelmingly positive. CONCLUSIONS: Neurosurgical critical care education is important for safe and effective care for patients. Clinical experience and didactic lectures help trainees obtain a solid knowledge base, but do not provide the benefit for learning in a fail-safe environment. Through the use of HPS, we have enhanced the critical care education of our trainees.


Asunto(s)
Cuidados Críticos/normas , Maniquíes , Neurocirugia/métodos , Simulación de Paciente , Educación Médica , Diseño de Equipo , Humanos , Internado y Residencia , Aprendizaje , Estudiantes de Medicina , Enseñanza/métodos
7.
J Neurosurg Spine ; 9(3): 261-4, 2008 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-18928222

RESUMEN

Tumor necrosis factor-alpha inhibitors are used to treat numerous chronic inflammatory and rheumatological diseases, such as Crohn disease, rheumatoid arthritis, and psoriatic arthritis. Because the mechanism of these inhibitors is to decrease the body's inflammatory response, the primary complication of treatment is infection. The authors present the first case of a spinal epidural abscess in a patient receiving long-term infliximab therapy for severe psoriatic arthritis. Infliximab and its side-effect profile are discussed, along with other associated complications.


Asunto(s)
Antiinflamatorios/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Artritis Psoriásica/tratamiento farmacológico , Absceso Epidural/etiología , Humanos , Infliximab , Masculino , Persona de Mediana Edad
8.
J Neurosurg Spine ; 28(5): 467-471, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29393833

RESUMEN

Cervical disc arthroplasty (CDA) has emerged as a popular alternative to anterior cervical discectomy and fusion (ACDF) for the surgical treatment of cervical degenerative disc disease. CDA has been well studied, with efficacy reported to be equivalent to or better than that seen with ACDF, and it is associated with a consistently low incidence of adverse events. The development or progression of myelopathy after CDA is a particularly rare occurrence. In this report, the authors describe the first known case of recurrence of myelopathy at the index level of surgery after CDA implantation due the continuation of the spondylitic process after placement of the artificial disc.


Asunto(s)
Artroplastia , Vértebras Cervicales/cirugía , Complicaciones Posoperatorias , Enfermedades de la Médula Espinal/etiología , Espondilosis/cirugía , Vértebras Cervicales/diagnóstico por imagen , Progresión de la Enfermedad , Discectomía , Humanos , Masculino , Persona de Mediana Edad , Reoperación , Enfermedades de la Médula Espinal/diagnóstico por imagen , Enfermedades de la Médula Espinal/cirugía , Fusión Vertebral , Espondilosis/diagnóstico por imagen
9.
Surg Neurol ; 67(4): 348-52, 2007 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-17350398

RESUMEN

BACKGROUND: Minimally invasive surgery is a promising new tool in treatment of spinal disorders. Minimally invasive laminectomy provides an efficacious means of achieving lumbar decompression. Present single-tube approaches may entail significant facet injury. We explore the feasibility of a dual-tube minimally invasive laminectomy approach in a cadaver model. METHODS: We performed minimally invasive lumbar laminectomies in 8 adult cadavers. Twenty-three levels were treated. We used a dual-tube technique, undercutting the facet joints bilaterally while attempting to minimize facet injury. Crossed-tube rongeuring of individual facet joints and neural foramina mirrored open techniques. Pre- and postoperative CT scans of the cadavers were obtained; we measured the cross-sectional area of the spinal canal and neural foramina in each specimen using a CT workstation. Facet damage was assessed. We used the Medtronic Sofamor-Danek (Memphis, Tenn) X-Tube and Quadrant systems to complete individual procedures. RESULTS: Increases in canal cross-sectional area were achieved in each specimen: L3-4 increased from 238.3 to 354.4 mm(2) (125.1%); L4-5, 274 to 390.9 mm(2) (142.7%); and L5-S1, 349.9 mm(2) to 458.8 mm(2) (131%). Neural foraminal diameter also increased in each specimen (L3-4 right increased 123%; left, 136.8%; L4-5, 143.5% and 145.6%; L5-S1, 124% and 116% respectively). Incidental facet injury was noted in 5 (10.9%) of a potential 46 joints. CONCLUSIONS: We demonstrate that a dual-tube MIS technique can effectively complete lumbar decompressive laminectomy and foraminotomy procedures in a cadaver model, without significant facet injury. Minimally invasive surgery laminectomy techniques hold significant clinical promise.


Asunto(s)
Laminectomía/métodos , Vértebras Lumbares , Adulto , Cadáver , Descompresión Quirúrgica/efectos adversos , Descompresión Quirúrgica/métodos , Estudios de Factibilidad , Humanos , Complicaciones Intraoperatorias , Laminectomía/efectos adversos , Procedimientos Quirúrgicos Mínimamente Invasivos , Articulación Cigapofisaria/lesiones
10.
Surg Technol Int ; 16: 221-5, 2007.
Artículo en Inglés | MEDLINE | ID: mdl-17429793

RESUMEN

Minimally invasive surgery (MIS) is a promising new tool in the treatment of a variety of spinal disorders. MIS laminectomy techniques provide an effective means of achieving lumbar decompression. MIS corpectomy techniques have not been described. If feasible, such a technique would be optimal in the treatment of spinal metastatic disease, where traditional open techniques can result in a significant burden to a compromised patient. In this study, we explored the feasibility of a dual-tube minimally invasive thoracic corpectomy approach in a cadaver model. A minimally invasive thoracolumbar costotransversectomy and corpectomy were perfumed in eight adult cadavers. A dual-tube technique was used to perform a costotransversectomy followed by a corpectomy on one side, and through the opposite tube a transpedicular approach on the contralateral side. Pre- and postoperative CT scans of all cadavers were obtained to measure the cross-sectional area of the vertebral bodies in each specimen via a CT workstation. Reconstruction of the anterior column was attempted in some cadavers using polymethylmethacrylate (PMMA) cement. A successful costotransversectomy and corpectomy were completed in each cadaver. A percutaneous delivery system was successful in allowing an anterior column reconstruction using PMMA as a strut graft in selected cadavers. We demonstrated that a dual-tube MIS approach to thoracic corpectomy is technically feasible. Additionally, spinal stabilization can be achieved via percutaneous PMMA administration. This approach may provide a minimally invasive option in the treatment of select spinal metastases.


Asunto(s)
Cementos para Huesos/uso terapéutico , Nutrición Enteral/instrumentación , Inyecciones/instrumentación , Laminectomía/instrumentación , Procedimientos Quirúrgicos Mínimamente Invasivos/instrumentación , Vértebras Torácicas/cirugía , Vertebroplastia/instrumentación , Cadáver , Humanos , Inyecciones/métodos , Laminectomía/métodos , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Resultado del Tratamiento , Vertebroplastia/métodos
11.
Neurosurg Focus ; 20(3): E10, 2006 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-16599416

RESUMEN

OBJECT: Posterior lumbar interbody fusion (PLIF) has been shown to be effective in the treatment of axial low-back pain. Minimally invasive spine surgery for arthrodesis has several advantages, including quicker patient recovery, less postoperative pain, and less destruction of adjacent tissue. The purpose of this paper is to evaluate the clinical outcomes after PLIF procedures in which unilateral pedicle screw fixation was used. METHODS: Prospective data were collected in 34 patients undergoing a one-level minimally invasive transforaminal lumbar interbody fusion (TLIF) in 2003. Conservative therapy, including physical therapy and aggressive multimodality pain management, had failed in all patients. Selection was based on magnetic resonance imaging studies demonstrating degenerative disc disease. All patients underwent a unilateral TLIF procedure in conjunction with posterior unilateral pedicle screw fixation. Twenty patients in whom the follow-up duration was longer than 6 months were included in this study. The follow-up duration in all patients ranged from 6 to 12 months. Seventeen (85%) of 20 patients had a good result, which was defined as a greater than 20-point reduction in the Oswestry Disability Index (ODI) score. The other three patients had no improvement. The mean preoperative ODI score of 57 improved to 25 after surgery (p < 0.005). In the 17 patients who demonstrated improvement, the mean ODI score improved from 57 to 18. The patients' visual analog scale pain scores improved from 8.3 to 1.4 (p < 0.005) after surgery. In patients who received Workers' Compensation, three (75%) of four improved. Follow-up computerized tomography scans were obtained in all 20 patients at 6 months. At that time, 13 of the patients demonstrated some degree of fusion, and no symptomatic pseudarthrosis was noted. CONCLUSIONS: Minimally invasive TLIF in conjunction with unilateral pedicle screw instrumentation is an effective treatment for axial low-back pain in appropriately selected patients.


Asunto(s)
Tornillos Óseos , Fijadores Internos , Dolor de la Región Lumbar/cirugía , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Fusión Vertebral/métodos , Adulto , Femenino , Estudios de Seguimiento , Humanos , Dolor de la Región Lumbar/diagnóstico por imagen , Dolor de la Región Lumbar/etiología , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Radiografía , Enfermedades de la Columna Vertebral/complicaciones , Enfermedades de la Columna Vertebral/radioterapia , Enfermedades de la Columna Vertebral/cirugía
12.
Neurosurgery ; 79(2): 169-81, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27050538

RESUMEN

BACKGROUND: Traditional surgical options for the treatment of symptomatic lumbar spinal stenosis include decompression alone vs decompression and fusion; both options have potential limitations. OBJECTIVE: To report the 36-month follow-up analysis of the coflex Interlaminar Stabilization (Paradigm Spine, LLC, New York, New York) after decompression, examined under a Food and Drug Administration investigational device exemption clinical trial, which is intended to provide stabilization after decompression while preserving normal segmental motion at the treated level. METHODS: The coflex trial was a prospective, randomized investigational device exemption study conducted at 21 clinical sites in the United States. Baseline and follow-up visits collected demographics, clinical, and radiographic status. The primary endpoint was a measure of composite clinical success 24 months postoperatively. For this current 36-month analysis, composite clinical success was calculated using analogous methods. RESULTS: Composite clinical success at 36 months was achieved by 62.2% among 196 coflex Interlaminar Stabilization patients and 48.9% among 94 fusion patients (difference = 13.3%, 95% confidence interval, 1.1%-25.5%, P = .03). Bayesian posterior probabilities for noninferiority (margin = -10%) and superiority of cofle Interlaminar Stabilization vs fusion were >0.999 and 0.984, respectively. Substantial and comparable improvements were observed in both groups for patient-reported outcomes, although the percentage with a clinically significant improvement (≥15) in the Oswestry Disability Index seemed larger for the coflex Interlaminar Stabilization group relative to the fusion group (P = .008). Radiographic measurements maintained index level and adjacent level range of motion in coflex Interlaminar Stabilization patients, although range of motion at the level superior to fusion was significantly increased (P = .005). CONCLUSION: Coflex Interlaminar Stabilization for stenosis is proven to be effective and durable at improving overall composite clinical success without altering normal spinal kinematic motion at the index level of decompression or adjacent levels. ABBREVIATIONS: CCS, composite clinical successCEC, clinical events committeeFDA, Food and Drug AdministrationIDE, investigational device exemptionILS, Coflex Interlaminar StabilizationODI, Oswestry Disability IndexSF-12, Short-Form 12VAS, visual analogue scalesZCQ, Zurich Claudication Questionnaire.


Asunto(s)
Descompresión Quirúrgica , Fijadores Internos , Vértebras Lumbares , Fusión Vertebral/instrumentación , Estenosis Espinal/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Teorema de Bayes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Complicaciones Posoperatorias/cirugía , Estudios Prospectivos , Rango del Movimiento Articular , Encuestas y Cuestionarios , Resultado del Tratamiento
13.
Int J Spine Surg ; 10: 6, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26913226

RESUMEN

INTRODUCTION: If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. METHODS: This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex(®) Interlaminar Stabilization(®) device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. RESULTS: At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height, disc space height, and range of motion at the index level were maintained through 5 years. CONCLUSION: Both treatment groups achieved and maintained statistically significant improvements on multiple outcome assessments throughout 5-year follow-up. On some clinical measures, there were statistically significant differences during early follow-up favoring D+ILS. At no point were there significant differences favoring D+PS. Results of this 5-year follow-up study demonstrate that decompression and interlaminar stabilization with coflex is a viable alternative to traditional decompression and fusion in the treatment of patients with moderate to severe stenosis at one or two lumbar levels. LEVEL OF EVIDENCE AND ETHICAL STATEMENTS: This is a Level I study. Institutional approval was received at each of the sites participating in the trial. Each patient gave informed consent to participate in the trial.

14.
Int J Spine Surg ; 9: 15, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-26056630

RESUMEN

BACKGROUND: Approved treatment modalities for the surgical management of lumbar spinal stenosis encompass a variety of direct and indirect methods of decompression, though all have varying degrees of limitations and morbidity which potentially limit the efficacy and durability of the treatment. The coflex(®) interlaminar stabilization implant (Paradigm Spine, New York, NY), examined under a United States Food and Drug Administration (US FDA) Investigational Device Exemption (IDE) clinical trial, is shown to have durable outcomes when compared to posterolateral fusion in the setting of post-decompression stabilization for stenotic patients. Other clinical and radiographic parameters, more indicative of durability, were also evaluated. The data collected from these parameters were used to expand the FDA composite clinical success (CCS) endpoint; thus, creating a more stringent Therapeutic Sustainability Endpoint (TSE). The TSE allows more precise calculation of the durability of interlaminar stabilization (ILS) when compared to the fusion control group. METHODS: A retrospective analysis of data generated from a prospective, randomized, level-1 trial that was conducted at 21 US sites was carried out. Three hundred forty-four per-protocol subjects were enrolled and randomized to ILS or fusion after decompression for lumbar stenosis with up to grade 1 degenerative spondylolisthesis. Clinical, safety, and radiographic data were collected and analyzed in both groups. Four-year outcomes were assessed, and the TSE was calculated for both cohorts. The clinical and radiographic factors thought to be associated with therapeutic sustainability were added to the CCS endpoints which were used for premarket approval (PMA). RESULTS: Success rate, comprised of no second intervention and an ODI improvement of ≥ 15 points, was 57.6% of ILS and 46.7% of fusion patients (p = 0.095). Adding lack of fusion in the ILS cohort and successful fusion in the fusion cohort showed a CCS of 42.7% and 33.3%, respectively. Finally, adding adjacent level success to both cohorts and maintenance of foraminal height in the coflex cohort showed a CCS of 36.6% and 25.6%, respectively. With additional follow-up to five years in the U.S. PMA study, these trends are expected to continue to show the superior therapeutic sustainability of ILS compared to posterolateral fusion after decompression for spinal stenosis. CONCLUSION: There are clear differences in both therapeutic sustainability and intended clinical effect of ILS compared to posterolateral fusion with pedicle screw fixation after decompression for spinal stenosis. There are CCS differences between coflex and fusion cohorts noted at four years post-op similar to the trends revealed in the two year data used for PMA approval. When therapeutic sustainability outcomes are added to the CCS, ILS is proven to be a sustainable treatment for stabilization of the vertebral motion segment after decompression for lumbar spinal stenosis.

15.
Am Surg ; 69(3): 191-6; discussion 196-7, 2003 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-12678473

RESUMEN

Managing cervical lymph node metastases in well-differentiated thyroid cancer with either "berry picking" (BP) or anatomic neck dissection (AND) has not been shown to alter survival. Nevertheless local control of thyroid cancer is important. The purpose of this study is to determine whether the local recurrence rate of well-differentiated thyroid cancer is equivalent with BP versus AND. A retrospective analysis revealed 41 patients with well-differentiated thyroid cancer and cervical node metastases seen by a single surgeon from 1985 to 2002. A total of 83 initial and repeat neck operations were performed (nine BPs, 30 central neck dissections, and 44 modified radical neck dissections). Recurrence of cancer, intervention for recurrence, and complications of the BP and AND groups were evaluated. All nine (100%) patients undergoing a limited BP operation had local recurrence of cancer. Only three of the 32 (9%) patients undergoing an initial formal neck operation had local recurrence of tumor. The recurrences after BP (100%) were significantly greater than the recurrences after AND (9%) (P < 0.001). The incidence of surgical complications with BP and AND was not different. Six of 32 (19%) initial formal neck dissection patients and four of nine (44%) BP patients had surgical complications. We conclude that BP is associated with greater local recurrence of thyroid cancer. Patients with nodal metastases should be managed with ANDs.


Asunto(s)
Recurrencia Local de Neoplasia/prevención & control , Neoplasias de la Tiroides/patología , Neoplasias de la Tiroides/cirugía , Tiroidectomía , Adolescente , Adulto , Anciano , Femenino , Humanos , Escisión del Ganglio Linfático , Metástasis Linfática , Masculino , Persona de Mediana Edad , Reoperación , Estudios Retrospectivos
17.
Neuropathology ; 28(1): 87-92, 2008 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-18069972

RESUMEN

Primary pineal gland malignancies are uncommon and seldom have papillary architecture. We report a case of a 22-year-old male patient who presented with progressive headache, horizontal nystagmus and worsening diplopia. MRI of the brain showed a lesion in the pineal region. The patient was taken for resection of the lesion which was classified as papillary tumor of pineal region (PTPR). Histologically, the neoplasm was cellular, characterized by eosinophilic cells with indistinct borders, large pleomorphic nuclei, numerous apoptotic figures without necrosis or microvascular proliferation. Prominent perivascular pseudorosettes were seen. Diffuse immunoreactivity for cytokeratin 8-18 was noted. Synaptophysin antibody showed membranous and cytoplasmic positivity. Weak staining for GFAP, vimentin, S-100 protein, and neuron specific enolase (NSE) were observed only focally. This is a case report of this rare pineal region neoplasm which only recently has been described as a histopathologic entity. Although the clinicopathological characteristics of this tumor are not entirely understood, a brief review of the literature as well as our contribution suggest an indolent neoplasm with a tendency for local recurrence. Histologically, PTPR demonstrates a unique assortment of epithelial, ependymal, and neuroendocrine features. The differential diagnosis of papillary neoplasms of the pineal region is reviewed.


Asunto(s)
Neoplasias Encefálicas/patología , Carcinoma Papilar/patología , Glándula Pineal/patología , Pinealoma/patología , Adulto , Neoplasias Encefálicas/complicaciones , Neoplasias Encefálicas/terapia , Carcinoma Papilar/complicaciones , Carcinoma Papilar/terapia , Diplopía/etiología , Cefalea/etiología , Humanos , Inmunohistoquímica , Imagen por Resonancia Magnética , Masculino , Procedimientos Neuroquirúrgicos , Nistagmo Patológico/etiología , Pinealoma/complicaciones , Pinealoma/terapia , Radioterapia
SELECCIÓN DE REFERENCIAS
Detalles de la búsqueda