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1.
Neurosurg Rev ; 44(4): 2111-2118, 2021 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-32851541

RESUMEN

Vertebral osteomyelitis (VO) is a severe infection of the vertebral body and the adjacent disc space, where Staphylococcus aureus is most commonly isolated. The objective of this retrospective study was to determine risk factors for and compare outcome differences between de novo methicillin-resistant Staphylococcus aureus (MRSA) VO and methicillin-sensitive Staphylococcus aureus (MSSA) VO. A retrospective cohort study was performed by review of the electronic medical records of 4541 consecutive spine surgery patients. Among these 37 underwent surgical treatment of de novo MRSA and MSSA spinal infections. Patient demographics, pre- and postoperative neurological status (ASIA impairment score), surgical treatment, inflammatory laboratory values, nutritional status, comorbidities, antibiotics, hospital stay, ICU stay, reoperation, readmission, and complications were collected. A minimum follow-up (FU) of 12 months was required. Among the 37 patients with de novo VO, 19 were MRSA and 18 were MSSA. Mean age was 52.4 and 52.9 years in the MRSA and MSSA groups, respectively. Neurological deficits were found in 53% of patients with MRSA infection and in 17% of the patients with MSSA infection, which was statistically significant (p < 0.05). Chronic renal insufficiency and malnutrition were found to be significant risk factors for MRSA VO. Preoperative albumin was significantly lower in the MRSA group (p < 0.05). Patients suffering from spinal infection with chronic renal insufficiency and malnutrition should be watched more carefully for MRSA. The MRSA group did not show a significant difference with regard to final clinical outcome despite more severe presentation.


Asunto(s)
Staphylococcus aureus Resistente a Meticilina , Infecciones Estafilocócicas , Antibacterianos/uso terapéutico , Humanos , Meticilina , Resistencia a la Meticilina , Persona de Mediana Edad , Estudios Retrospectivos , Infecciones Estafilocócicas/tratamiento farmacológico , Infecciones Estafilocócicas/epidemiología , Staphylococcus aureus
2.
Neurosurg Focus ; 51(4): E4, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34598129

RESUMEN

OBJECTIVE: The purpose of this retrospective cohort study was to analyze the early complications and mortality associated with multilevel spine surgery for unstable fractures in patients older than 80 years of age with ankylosing spondylitis and to compare the results with an age- and sex-matched cohort of patients with unstable osteoporotic fractures. METHODS: A retrospective review of the electronic medical records at a single institution was conducted between January 2014 and December 2019. Patient demographics, surgical characteristics, complications, hospital course, and 90-day mortality were collected. Comorbidities were stratified using the age-adjusted Charlson Comorbidity Index (CCI). RESULTS: Among 11,361 surgically treated patients, 22 patients with ankylosing spondylitis (AS group) and 24 patients with osteoporosis (OS group) were identified. The mean ages were 83.1 ± 3.1 years and 83.2 ± 2.6 years, respectively. A significant difference in the mean CCI score was found (7.6 vs 5.6; p < 0.001). Multilevel posterior fusion procedures were conducted in all patients, with 6.7 ± 1.4 fused levels in the AS group and 7.1 ± 1.1 levels fused in the OS group (p > 0.05). Major complications developed in 10 patients (45%) in the AS group compared with 4 patients (17%) in the OS group (p < 0.05). The 90-day mortality was 36% in the AS group compared with 0% in the OS group (p < 0.001). CONCLUSIONS: Patients older than 80 years of age with AS bear a high risk of adverse events after multilevel spinal fusion procedures. The high morbidity and 90-day mortality should be clearly discussed and carefully weighed against surgical treatment.


Asunto(s)
Osteoporosis , Fracturas de la Columna Vertebral , Fusión Vertebral , Espondilitis Anquilosante , Anciano de 80 o más Años , Humanos , Osteoporosis/complicaciones , Osteoporosis/cirugía , Estudios Retrospectivos , Fracturas de la Columna Vertebral/cirugía , Fusión Vertebral/efectos adversos , Espondilitis Anquilosante/complicaciones , Espondilitis Anquilosante/cirugía , Resultado del Tratamiento
3.
Neurosurg Rev ; 43(5): 1423-1430, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-31919700

RESUMEN

Recently, a bioactive glass ceramic (BGC) has been developed for use as intervertebral cages for anterior cervical discectomy and fusion (ACDF). However, the effectiveness and safety of BGC cages remain to be evaluated. We completed a retrospective comparison of the radiological and clinical outcomes of 36 patients (52 levels) who underwent ACDF with a BGC cage and 35 patients (54 levels) using allograft bone. The following variables were compared between the two groups: the visual analog (VAS) neck and arm pain score and the neck disability index (NDI), measured before surgery and 1 year after; the change in Cobb's angle, between the C2 and C7 vertebrae, the global sagittal angle, and disc height compared from before surgery to 1 year after; and the rate of spinal fusion and cage subsidence at 1 and 2 years after surgery. The VAS and NDI scores were not different between the two groups. Similarly, the spinal fusion rate was not different between the BGC and allograft bone group at 1 year (73% and 87%, respectively; p = 0.07) and 2 years (94% and 91%, respectively; p = 0.54) after surgery. However, the rate of cage subsidence was higher in the allograft bone (43%) than the BGC (19%) group (p = 0.03), as was the rate of instrument-related failure (p = 0.028), with a specifically higher incidence of implant fracture or failure in the allograft bone group (p = 0.025). Overall, our findings indicate that BGC cages provide a feasible and safe alternative to allograft bone for ACDF.


Asunto(s)
Placas Óseas , Trasplante Óseo/métodos , Cerámica , Vértebras Cervicales/cirugía , Discectomía/métodos , Fusión Vertebral/métodos , Adulto , Anciano , Trasplante Óseo/efectos adversos , Vértebras Cervicales/diagnóstico por imagen , Evaluación de la Discapacidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor de Cuello/cirugía , Dimensión del Dolor , Estudios Retrospectivos , Resultado del Tratamiento
4.
Global Spine J ; 13(1): 164-171, 2023 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33715487

RESUMEN

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: The purpose of the study was to compare early complication, morbidity and mortality risks associated with fusion surgery crossing the cervico-thoracic junction in patients aged over 80 years undergoing combined anterior and posterior approach versus a posterior-only approach. METHODS: We retrospectively identified octogenarian patients with myelopathy who underwent fusion crossing the cervico-thoracic junction. Patient demographics, Nurick score, surgical characteristics, complications, hospital course, early outcome and 90-day mortality were collected. Comorbidities were classified using the age-adjusted Charlson Comorbidity Index (AACCI). Radiographic measurements for deformity correction included the C2-C7 sagittal Cobb angle, C2-7 sagittal vertical axis and T1 slope pre- and postoperatively. RESULTS: Out of 8,521 surgically treated patients, 12 octogenarian patients had a combined anterior and posterior approach (AP group) and 14 were treated from posterior-only (P group). Mean age was 81.4 ± 1.2 and 82.5 ± 2.7 years, respectively. There was no significant difference in Nurick scores between the groups (P > 0.05). The major complication risk in the AP group was significantly higher, requiring PEG tube placement due to severe dysphagia in 4 patients (33%) compared to none in the P group. A greater improvement in cervical lordosis could be achieved through a combined approach. The 90-day mortality risk was 8% for the AP group and 0% for the P group. CONCLUSIONS: A combined anterior and posterior approach is associated with a significantly higher major complication rate and can result in severe dysphagia requiring PEG tube placement in one-third of patients over 80 years of age.

5.
Oper Neurosurg (Hagerstown) ; 22(4): 231-238, 2022 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-35147593

RESUMEN

BACKGROUND: The lack of stereoscopic vision in endoscopic spine surgery may lead to a risk of neural or vascular injury during endoscopic surgery. Three-dimensional (3D) endoscopy has not yet been attempted in the field of spinal endoscopic surgery. OBJECTIVE: To present the technique, clinical efficacy, and safety of the 3D biportal endoscopic approach for the treatment of lumbar degenerative disease. METHODS: We attempted 3D biportal endoscopic surgery for lumbar degenerative disease in a series of patients. Clinical outcomes and complications were evaluated postoperatively using a short questionnaire about 3D biportal endoscopic spine surgery that solicited respondents' opinions on the advantages and disadvantages of 3D biportal endoscopic surgery compared to the conventional 2D biportal endoscopic approach. RESULTS: We performed 3D biportal endoscopic spine surgery in 38 patients with lumbar degenerative disease. Optimal neural decompression was revealed by postoperative magnetic resonance imaging in all enrolled patients. The 3D endoscopic vision clearly demonstrated the surgical anatomy starting with the exposure of ligamentum flavum, dura, and nerve root, and 3D endoscopy precisely depicted pathologic lesions such as bony osteophytes and ruptured disc herniation. There were no major complications including neural injury or durotomy. CONCLUSION: The 3D endoscope may be able to distinguish between normal structures and lesions. The stereognosis and depth sensation of 3D biportal endoscopic spinal surgery might have a favorable impact on the safety of patients during endoscopic spine surgery.


Asunto(s)
Desplazamiento del Disco Intervertebral , Estenosis Espinal , Descompresión Quirúrgica/métodos , Endoscopía/métodos , Humanos , Desplazamiento del Disco Intervertebral/cirugía , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Estenosis Espinal/diagnóstico por imagen , Estenosis Espinal/cirugía
6.
Mol Med Rep ; 19(3): 2377-2385, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30664218

RESUMEN

Leukemia inhibitory factor (LIF) is a multifunctional cytokine. The present study aimed to determine the expression and effects of LIF on nucleus pulposus generation. Degenerated nucleus pulposus samples were obtained from animal models and patients with lumbar intervertebral disc herniation. Degradation scores of intervertebral discs were evaluated via magnetic resonance imaging (MRI) and histology, and the protein expression levels of LIF were detected. Furthermore, cultured primary human degenerated nucleus pulposus cells (DNPCs) were stimulated with various concentrations of recombinant human LIF protein (rhLIF), and aggrecan and collagen type II α1 (COL2α1) protein expression levels were detected by western blotting. In addition, aggrecan expression was determined by toluidine blue staining. The effects of rhLIF on proliferation and apoptosis of DNPCs were evaluated by Cell Counting Kit­8 and flow cytometry, respectively. The results revealed that the degradation scores of intervertebral discs were significantly associated with modeling time, as determined by MRI and histology. In addition, the protein expression levels of LIF were initially increased in patients with lumbar disc herniation and in rabbit models, particularly in the 2­week modeling group; however, its expression decreased with the progression of disc degeneration. Notably, LIF expression in each modeling group was higher than that in the control and 0 week modeling group. The in vitro study revealed that the protein expression levels of aggrecan and COL2α1 were significantly increased in response to rhLIF, in a dose­dependent manner, and statistical differences were identified between the treatment groups and control group. The results of toluidine blue staining were consistent with this finding. Although rhLIF had no effect on proliferation, it inhibited apoptosis of DNPCs in a concentration­dependent manner. In conclusion, LIF was upregulated during the process of intervertebral disc degeneration, and may promote the expression of extracellular matrix components. It may also be hypothesized that LIF acts as a potential protective factor by inhibiting apoptosis of DNPCs without affecting cell proliferation.


Asunto(s)
Degeneración del Disco Intervertebral/tratamiento farmacológico , Factor Inhibidor de Leucemia/genética , Núcleo Pulposo/efectos de los fármacos , Proteínas Recombinantes/administración & dosificación , Agrecanos/genética , Animales , Apoptosis/efectos de los fármacos , Proliferación Celular/efectos de los fármacos , Colágeno Tipo II/genética , Femenino , Citometría de Flujo , Regulación de la Expresión Génica/efectos de los fármacos , Humanos , Disco Intervertebral/diagnóstico por imagen , Disco Intervertebral/metabolismo , Disco Intervertebral/fisiopatología , Degeneración del Disco Intervertebral/genética , Degeneración del Disco Intervertebral/fisiopatología , Desplazamiento del Disco Intervertebral/tratamiento farmacológico , Desplazamiento del Disco Intervertebral/genética , Desplazamiento del Disco Intervertebral/fisiopatología , Factor Inhibidor de Leucemia/administración & dosificación , Imagen por Resonancia Magnética , Masculino , Núcleo Pulposo/diagnóstico por imagen , Núcleo Pulposo/crecimiento & desarrollo , Núcleo Pulposo/patología , Conejos , Proteínas Recombinantes/genética
7.
JAMA Surg ; 153(7): 634-642, 2018 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-29516096

RESUMEN

Importance: Functional impairment and pain are common indications for the initiation of lumbar spine surgery, but information about expected improvement in these patient-reported outcome (PRO) domains is not readily available to most patients and clinicians considering this type of surgery. Objective: To assess population-level PRO response after lumbar spine surgery, and develop/validate a prediction tool for PRO improvement. Design, Setting, and Participants: This statewide multicenter cohort was based at 15 Washington state hospitals representing approximately 75% of the state's spine fusion procedures. The Spine Surgical Care and Outcomes Assessment Program and the survey center at the Comparative Effectiveness Translational Network prospectively collected clinical and PRO data from adult candidates for lumbar surgery, preoperatively and postoperatively, between 2012 and 2016. Prediction models were derived for PRO improvement 1 year after lumbar fusion surgeries on a random sample of 85% of the data and were validated in the remaining 15%. Surgical candidates from 2012 through 2015 were included; follow-up surveying continued until December 31, 2016, and data analysis was completed from July 2016 to April 2017. Main Outcomes and Measures: Functional improvement, defined as a reduction in Oswestry Disability Index score of 15 points or more; and back pain and leg pain improvement, defined a reduction in Numeric Rating Scale score of 2 points or more. Results: A total of 1965 adult lumbar surgical candidates (mean [SD] age, 61.3 [12.5] years; 944 [59.6%] female) completed baseline surveys before surgery and at least 1 postoperative follow-up survey within 3 years. Of these, 1583 (80.6%) underwent elective lumbar fusion procedures; 1223 (77.3%) had stenosis, and 1033 (65.3%) had spondylolisthesis. Twelve-month follow-up participation rates for each outcome were between 66% and 70%. Improvements were reported in function, back pain, and leg pain at 12 months by 306 of 528 surgical patients (58.0%), 616 of 899 patients (68.5%), and 355 of 464 patients (76.5%), respectively, whose baseline scores indicated moderate to severe symptoms. Among nonoperative patients, 35 (43.8%), 47 (53.4%), and 53 (63.9%) reported improvements in function, back pain, and leg pain, respectively. Demographic and clinical characteristics included in the final prediction models were age, sex, race, insurance status, American Society of Anesthesiologists score, smoking status, diagnoses, prior surgery, prescription opioid use, asthma, and baseline PRO scores. The models had good predictive performance in the validation cohort (concordance statistic, 0.66-0.79) and were incorporated into a patient-facing, web-based interactive tool (https://becertain.shinyapps.io/lumbar_fusion_calculator). Conclusions and Relevance: The PRO response prediction tool, informed by population-level data, explained most of the variability in pain reduction and functional improvement after surgery. Giving patients accurate information about their likelihood of outcomes may be a helpful component in surgery decision making.


Asunto(s)
Pierna , Dolor de la Región Lumbar/cirugía , Vértebras Lumbares/cirugía , Modelos Teóricos , Dolor/cirugía , Medición de Resultados Informados por el Paciente , Fusión Vertebral , Estudios de Cohortes , Femenino , Predicción , Humanos , Masculino , Persona de Mediana Edad , Recuperación de la Función , Resultado del Tratamiento
8.
Spine (Phila Pa 1976) ; 41(1): 3-8, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26335669

RESUMEN

STUDY DESIGN: This was a prospective, randomized, controlled, multicenter study. OBJECTIVE: The purpose of this study was to compare outcomes of two lumbar total disc replacements (TDRs) at 5-year follow-up and report results of serum ion level analysis in a subgroup of patients receiving a metal-on-metal implant. SUMMARY OF BACKGROUND DATA: Lumbar TDR has been compared with fusion in several randomized studies, finding TDR noninferior to fusion and superior on some measures. Receiving less attention has been comparing TDR devices. Additionally, there is concern about metal-on-metal implants, with little data available for spine devices. METHODS: The study included 204 patients receiving Kineflex-L (investigational) and 190 receiving CHARITÉ (control). Outcome measure included Oswestry Disability Index, visual analog pain scales (VAS), patient satisfaction, neurological status, complications, reoperations, and a composite success score. Radiographic assessment included range of motion, subsidence, and heterotrophic ossification. In 32 investigational patients, serum ion analysis was performed for cobalt and chromium. These values were compared with Medicines and Healthcare Products Regulatory Agency values to merit monitoring total hip replacement patients for potential wear problems. RESULTS: Mean Oswestry and VAS scores in both groups improved significantly by 6 weeks and remained improved during 5-year follow-up (Oswestry Disability Index, scores in both groups were approximately 60 preoperatively vs. 20 at 2- and 5-year follow-up; P < 0.01; VAS scores improved >50% by 6 weeks and remained significantly improved; P < 0.05). Approximately 11% of both groups underwent reoperation. Radiographic analysis found segmental range of motion decreased at 3 month, then increased through 24 months, and was maintained thereafter. Serum ion level analysis found the greatest mean value at any follow-up point was less than 20% of Medicines and Healthcare Products Regulatory Agency recommended minimum value to merit monitoring hip replacement patients. CONCLUSION: This prospective, randomized study comparing two TDRs found no significant differences in outcomes during 5-year follow-up. Both provided statistically significant improvements by 6 weeks that were maintained. This results support other studies. Serum ion levels in TDR patients were well below the recommended threshold levels to merit monitoring.


Asunto(s)
Vértebras Lumbares/cirugía , Prótesis e Implantes/estadística & datos numéricos , Reeemplazo Total de Disco/efectos adversos , Reeemplazo Total de Disco/estadística & datos numéricos , Adulto , Cromo/sangre , Cobalto/sangre , Estudios de Seguimiento , Humanos , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/fisiopatología , Prótesis e Implantes/efectos adversos , Radiografía , Rango del Movimiento Articular , Reeemplazo Total de Disco/instrumentación , Resultado del Tratamiento
9.
J Bone Joint Surg Am ; 87(8): 1732-8, 2005 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-16085612

RESUMEN

BACKGROUND: Chin-on-chest deformity is a disabling manifestation of ankylosing spondylitis. Surgical treatment consists of extension osteotomy at the cervicothoracic junction. The purpose of this study was to characterize the clinical presentation of this deformity and to determine the long-term functional and radiographic outcomes of treatment. METHODS: The medical records and radiographs of all twenty-six patients treated with cervicothoracic extension osteotomy by one of us between 1976 and 2001 were retrospectively reviewed. Three patients died during the two-year-minimum follow-up period. The remaining twenty-three patients were followed for an average of 4.5 years (range, two years to twenty-one years and ten months). RESULTS: The mean sagittal correction was 38 degrees. Delayed union in two patients and additional cervical trauma in two others resulted in partial loss of the initial correction. Quadriplegia developed in one patient, who died as a result of subluxation at the osteotomy site. Five patients had irritation of the eighth cervical nerve root postoperatively. CONCLUSIONS: Extension osteotomy can reliably improve sagittal alignment and horizontal gaze as well as decrease neck pain, eating difficulties, and neurologic abnormalities. Internal fixation is recommended to prevent subluxation, delayed union, nonunion, loss of correction, or neurologic injury. There is a risk of death or catastrophic neurologic injury from the procedure.


Asunto(s)
Vértebras Cervicales/cirugía , Osteotomía/métodos , Espondilitis Anquilosante/complicaciones , Vértebras Torácicas/cirugía , Adulto , Anciano , Hilos Ortopédicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor de Cuello/etiología
10.
J Bone Joint Surg Am ; 87(3): 610-5, 2005 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-15741630

RESUMEN

BACKGROUND: Ossification of the posterior longitudinal ligament is commonly associated with cervical myelopathy. Surgical treatment is a matter of controversy. We report on a series of patients who were managed with anterior cervical decompression and arthrodesis for the treatment of cervical myelopathy associated with ossification of the posterior longitudinal ligament. METHODS: We retrospectively reviewed the records for all sixty-five patients who had been managed with anterior decompression and arthrodesis for the treatment of cervical ossification of the posterior longitudinal ligament and associated neurologic compression from 1982 to 2001. Sixty-one patients (thirty-nine men and twenty-two women) were followed for at least two years (or until the time of death). The average number of vertebrae resected was 2.2. The average duration of follow-up for the sixty surviving patients was four years (range, two years to fifteen years and four months). The preoperative, six-week postoperative, and final follow-up clinical status (including neurological function as assessed with the Nurick grading system) was recorded for each patient. RESULTS: Fifty-six of the sixty-one patients had neurological improvement, with an average improvement of 1.5 Nurick grades at the time of the final follow-up. Eight patients had absent dura at the time of surgery and, of these, five had development of a cerebrospinal fluid fistula. Eight patients had development of new neurological signs and/or symptoms in the upper extremity postoperatively. Eight patients required reoperation because of a painful pseudarthrosis (one patient), strut-graft dislodgment (three), cerebrospinal fluid leakage (three), or compression of a nerve root caudad to the area of the original procedure (one). One patient died as the result of cardiac arrest on the third postoperative day. Fifty-eight patients had an osseous fusion, one had an asymptomatic nonunion, and one had a symptomatic pseudarthrosis that was treated with revision surgery. CONCLUSIONS: Anterior decompression and arthrodesis is an effective way to achieve pain relief and neurological improvement in North American patients of non-Asian descent who have cervical myelopathy associated with ossification of the posterior longitudinal ligament. The risk of durocutaneous fistula, graft dislodgment, and postoperative neurological symptoms appears to be high in patients with cervical myelopathy associated with this condition.


Asunto(s)
Artrodesis , Descompresión Quirúrgica , Osificación del Ligamento Longitudinal Posterior/cirugía , Femenino , Estudios de Seguimiento , Humanos , Masculino , Cuello , Complicaciones Posoperatorias , Seudoartrosis/etiología , Radiculopatía/etiología , Reoperación , Estudios Retrospectivos , Enfermedades de la Médula Espinal/complicaciones , Enfermedades de la Médula Espinal/cirugía , Efusión Subdural/etiología , Resultado del Tratamiento
11.
Orthop Clin North Am ; 36(3): 255-62, 2005 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-15950685

RESUMEN

Degenerative disorders in the spine are normal, age-related phenomena and largely asymptomatic in most cases. Conservative management of lumbar and cervical spondylosis is the mainstay of treatment, and most patients with symptomatic degenerative changes respond appropriately with nonsurgical management. Surgical intervention can be considered an appropriate and viable option when conservative measures have failed. Treatment options should always be directed toward the specific nature and location of the patient's individual pathology. Although current standards in the surgical management of lumbar and cervical degenerative disorders include discectomy, neural decompression, and instrumented spinal arthrodesis, new approaches that address this often-challenging clinical entity are on the horizon.


Asunto(s)
Vértebras Cervicales/patología , Vértebras Lumbares/patología , Imagen por Resonancia Magnética , Osteofitosis Vertebral/diagnóstico , Osteofitosis Vertebral/terapia , Anciano , Anciano de 80 o más Años , Envejecimiento/fisiología , Terapia Combinada , Femenino , Humanos , Incidencia , Desplazamiento del Disco Intervertebral/diagnóstico , Desplazamiento del Disco Intervertebral/epidemiología , Desplazamiento del Disco Intervertebral/terapia , Masculino , Persona de Mediana Edad , Procedimientos Ortopédicos/métodos , Osteoartritis/diagnóstico , Osteoartritis/epidemiología , Osteoartritis/terapia , Modalidades de Fisioterapia , Pronóstico , Medición de Riesgo , Índice de Severidad de la Enfermedad , Osteofitosis Vertebral/epidemiología
12.
Spine (Phila Pa 1976) ; 39(12): 925-31, 2014 May 20.
Artículo en Inglés | MEDLINE | ID: mdl-24718066

RESUMEN

STUDY DESIGN: This was a prospective, randomized, controlled multicenter study with 24-month follow-up. OBJECTIVE: The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale. SUMMARY OF BACKGROUND DATA: Randomized trials have reported TDR to produce results similar or superior to lumbar fusion. Results for various TDRs seem to be similar, but differences in study design and outcome measures pose challenges in definitively comparing devices. The purpose of this study was to perform a direct comparison of 2 lumbar TDRs in a prospective, randomized trial. METHODS: TDR was performed in 457 patients from 21 sites (261 patients in the investigational group (Kineflex-L Disc; metal-on-metal design anchored with keels, 204 randomized and 57 nonrandomized training cases), and 196 in the control group (CHARITE artificial disc; metal with polyethylene core with teeth for anchoring; 190 randomized and 6 nonrandomized training cases). All patients were treated nonoperatively for single-level symptomatic disc degeneration for at least 6 months prior to surgery. Perioperative data were collected. Clinical outcome data were collected prospectively, as approved by the Food and Drug Administration, through 24-month follow-up. Primary outcome measures used were the Oswestry Disability Index, visual analogue scales assessing pain, patient satisfaction, and reoperations. Success was defined to be at least 15-point improvements in Oswestry Disability Index scores, no reoperation, and no major adverse events. Radiographical measures included range of motion, disc space height, and assessment for device migration, subsidence, and fusion at the TDR level. RESULTS: There were no significant differences between the groups when comparing operative time, blood loss, or length of hospital stay. Both groups improved significantly on Oswestry Disability Index and visual analogue scale scores (P < 0.01) with no differences between the groups. Success rates were similar (68.1% investigational vs. 67.4% control). At 24-month follow-up, 94.1% of the investigational group and 91.9% of controls were satisfied with outcome. Reoperation was performed in 10.3% of the investigational group and 8.4% of the control group. CONCLUSION: This prospective, randomized, controlled study comparing 2 TDRs, the first to the authors' knowledge, found the devices produced very similar clinical outcomes. Both groups improved significantly by 6 weeks postoperatively and remained improved throughout follow-up with a high patient satisfaction rate.


Asunto(s)
Degeneración del Disco Intervertebral/cirugía , Vértebras Lumbares/cirugía , Reeemplazo Total de Disco/instrumentación , Adolescente , Adulto , Evaluación de la Discapacidad , Diseño de Equipo , Femenino , Estudios de Seguimiento , Humanos , Vértebras Lumbares/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Complicaciones Posoperatorias , Estudios Prospectivos , Radiografía , Rango del Movimiento Articular , Reoperación , Resultado del Tratamiento , Adulto Joven
13.
J Orthop Surg Res ; 8: 49, 2013 Dec 28.
Artículo en Inglés | MEDLINE | ID: mdl-24373225

RESUMEN

BACKGROUND: Since the introduction of rhBMP-2 (Infuse) in 2002, surgeons have had an alternative substitute to autograft and its related donor site morbidity. Recently, the prevalence of reported adverse events and complications related to the use of rhBMP-2 has raised many ethical and legal concerns for surgeons. Additionally, the cost and decreasing reimbursement landscape of rhBMP-2 use have required identification of a viable alternative. Osteo allogeneic morphogenetic protein (OsteoAMP) is a commercially available allograft-derived growth factor rich in osteoinductive, angiogenic, and mitogenic proteins. This study compares the radiographic fusion outcomes between rhBMP-2 and OsteoAMP allogeneic morphogenetic protein in lumbar interbody fusion spine procedures. METHODS: Three hundred twenty-one (321) patients from three centers underwent a transforaminal lumbar interbody fusion (TLIF) or lateral lumbar interbody fusion (LLIF) procedure and were assessed by an independent radiologist for fusion and radiographically evident complications. The independent radiologist was blinded to the intervention, product, and surgeon information. Two hundred and twenty-six (226) patients received OsteoAMP with autologous local bone, while ninety-five (95) patients received Infuse with autologous local bone. Patients underwent radiographs (x-ray and/or CT) at standard postoperative follow-up intervals of approximately 1, 3, 6, 12, and 18 months. Fusion was defined as radiographic evidence of bridging across endplates, or bridging from endplates to interspace disc plugs. Osteobiologic surgical supply costs were also analyzed to ascertain cost differences between OsteoAMP and rhBMP-2. RESULTS: OsteoAMP produced higher rates of fusion at 6, 12, and 18 months (p ≤ 0.01). The time required for OsteoAMP to achieve fusion was approximately 40% less than rhBMP-2 with approximately 70% fewer complications. Osteobiologic supply costs were 80.5% lower for OsteoAMP patients (73.7% lower per level) than for rhBMP-2. CONCLUSIONS: Results of this study indicate that OsteoAMP is a viable alternative to rhBMP-2 both clinically and economically when used in TLIF and LLIF spine procedures.


Asunto(s)
Proteínas Morfogenéticas Óseas/uso terapéutico , Vértebras Lumbares/cirugía , Fusión Vertebral/métodos , Adulto , Anciano , Proteína Morfogenética Ósea 2/efectos adversos , Proteína Morfogenética Ósea 2/economía , Proteína Morfogenética Ósea 2/uso terapéutico , Proteínas Morfogenéticas Óseas/efectos adversos , Proteínas Morfogenéticas Óseas/economía , Trasplante Óseo/métodos , Costos de los Medicamentos/estadística & datos numéricos , Evaluación de Medicamentos/métodos , Femenino , Humanos , Vértebras Lumbares/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Osificación Heterotópica/inducido químicamente , Osteólisis/inducido químicamente , Radiografía , Proteínas Recombinantes/efectos adversos , Proteínas Recombinantes/economía , Proteínas Recombinantes/uso terapéutico , Estudios Retrospectivos , Método Simple Ciego , Fusión Vertebral/efectos adversos , Factor de Crecimiento Transformador beta/efectos adversos , Factor de Crecimiento Transformador beta/economía , Factor de Crecimiento Transformador beta/uso terapéutico , Resultado del Tratamiento
14.
J Spinal Disord Tech ; 21(5): 334-7, 2008 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-18600143

RESUMEN

STUDY DESIGN: Retrospective chart review of documented adverse events in 637 consecutive patients after computed tomogram myelography and follow-up interview of the most recent 100 of these patients. OBJECTIVES: This study assessed documented prevalence of adverse events after diagnostic myelography in cervical spondylotic patients and compared with perceived adverse events and satisfaction in a subset of the same cohort of patients. SUMMARY OF BACKGROUND DATA: There are some data that suggest complimentary benefits of myelography to magnetic resonance imaging. However, given the invasive nature of myelography, there are little data documenting the adverse events and patient experience with myelography to guide informed consent and physician choice of this study. METHODS: We analyzed the records of 637 consecutive patients (364 males and 273 females) after myelography. Five hundred forty-four patients (group 1) had a cervical approach and 93 (group 2) had a lumbar approach. The last 100 consecutive patients (85 in group 1 and 15 in group 2) were asked questions that addressed patient perceived adverse reactions, pain levels, and satisfaction. RESULTS: There was a 4.4% (28/637) prevalence of documented abnormal reactions. Group 1 had a 4.9% (25/506) prevalence of adverse reactions compared with 3.4% (3/89) in group 2. Overall 6.6% (42/637) had to have their myelographic procedures converted. Group 1 had 7% (38/544) converted to the lumbar approach group 2 had 4.3% (4/93) converted to the cervical approach. Thirty percent of the 100 patients interviewed felt they had an unexpected reaction (28 group 1 and 2 group 2). When interviewed, 14% of patients had maximum pain scores of 10 during the procedure and 8% (all group 1) felt worse pain after the procedure was completed. Six group 1 and 2 group 2 patients would not have the procedure again even when recommended by the surgeon. There was no statistically significant difference between complication rates, conversion rates, or patient perceived unexpected reactions between the 2 groups (beta=0.90). CONCLUSIONS: This paper demonstrated the discrepancy between documented adverse events with computed tomogram myelography and patient reported tolerance as recorded by telephone follow-up. The cervical approach had a greater degree of patient perceived discomfort and a trend toward higher documented and patient reported adverse events and rate of approach conversion to a lumbar approach (P>0.5). When choosing myelography to evaluate patients with cervical spondylosis, the surgeon should consider the low patient tolerance and frequent adverse reactions that often go undocumented.


Asunto(s)
Vértebras Cervicales/diagnóstico por imagen , Mielografía/efectos adversos , Complicaciones Posoperatorias/etiología , Radiculopatía/diagnóstico por imagen , Osteofitosis Vertebral/diagnóstico por imagen , Tomografía Computarizada por Rayos X/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Vértebras Cervicales/patología , Vértebras Cervicales/fisiopatología , Femenino , Humanos , Complicaciones Intraoperatorias/etiología , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/patología , Vértebras Lumbares/fisiopatología , Masculino , Persona de Mediana Edad , Mielografía/estadística & datos numéricos , Umbral del Dolor/psicología , Dolor Postoperatorio/etiología , Satisfacción del Paciente , Selección de Paciente , Prevalencia , Radiculopatía/patología , Radiculopatía/fisiopatología , Estudios Retrospectivos , Compresión de la Médula Espinal/diagnóstico por imagen , Compresión de la Médula Espinal/patología , Compresión de la Médula Espinal/fisiopatología , Osteofitosis Vertebral/patología , Osteofitosis Vertebral/fisiopatología , Encuestas y Cuestionarios , Tomografía Computarizada por Rayos X/estadística & datos numéricos
15.
Spine (Phila Pa 1976) ; 33(6): 668-72, 2008 Mar 15.
Artículo en Inglés | MEDLINE | ID: mdl-18344861

RESUMEN

STUDY DESIGN: Thromboembolic disease (TED) after anterior/posterior spinal reconstructions was prospectively evaluated in 66 consecutive patients. OBJECTIVE: Determine the incidence of TED after anterior/posterior spinal reconstruction. SUMMARY OF BACKGROUND DATA: Few studies have examined the rate of TED after potentially high-risk combined anterior/posterior reconstructions. Magnetic resonance venography (MRV) is more effective at detecting pelvic deep venous thrombosis (DVT) than conventional screening, but has not been used in these patients. METHODS: We undertook a prospective cohort study of 66 consecutive adult patients (mean, 52.7 +/- 9.6 years) undergoing combined anterior/posterior spinal reconstructions for spinal deformity. All patients received only mechanical DVT prophylaxis. After surgery, MRV and bilateral lower extremity Doppler ultrasounds were obtained to screen for DVT, and contrast-enhanced spiral computed tomography scans were obtained for clinical suspicion of pulmonary embolism (PE). RESULTS: The total incidence of postoperative TED was 13.6% (9 patients). The overall rate of DVT was 9.1% (6 patients), one-third occurring in the pelvis. PE developed in 7.6% (5 patients). In 2 patients, PE developed less than 48 hours after positive dopplers. In 3 patients, PE developed despite negative screening studies. Right-sided thoracoabdominal approaches were associated with an increased risk of developing DVT (P = 0.03, Odds Ratio 9.8), PE (P = 0.01, Odds Ratio 20), and TED (P = 0.004, Odds Ratio 12). CONCLUSION: We report a high rate of TED after extensive anterior/posterior spinal reconstructions, for which a right-sided thoracoabdominal approach is an independent risk factor and screening ineffective at preventing PE. These patients should be considered at high risk for postoperative TED.


Asunto(s)
Espectroscopía de Resonancia Magnética/métodos , Procedimientos de Cirugía Plástica/métodos , Médula Espinal/anomalías , Médula Espinal/cirugía , Tromboembolia/cirugía , Adulto , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Flebografía/métodos , Complicaciones Posoperatorias/patología , Complicaciones Posoperatorias/cirugía , Estudios Prospectivos , Médula Espinal/patología , Tromboembolia/etiología , Tromboembolia/patología
16.
J Spinal Disord Tech ; 19(1): 18-21, 2006 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-16462213

RESUMEN

OBJECTIVE: Prior cadaveric research showed that the lateral mass and facets are landmarks to determine the initial starting point for lateral mass screws and that the optimum screw trajectory was 30 degrees lateral and 15 degrees cephalad. The missing link was an intraoperative landmark to guide the trajectory for drilling according to these angles. The authors hypothesized that spinous processes can be used to guide the trajectory for lateral mass screw placement. METHODS: The authors analyzed 144 lateral masses of 72 cervical vertebrae in 18 cadavers (7 males and 11 females). The lateral and cephalocaudad angles were measured for each lateral mass from C3 to C6 while using the spinous processes of the adjacent three caudad vertebrae at each level to guide the starting trajectories for a total of 864 angles. The lateral and cephalad trajectory angles at each spinous process relative to the starting hole were compared with 30 degrees and 15 degrees . For each angle measured at a particular level, the same starting hole was used in the lateral mass, and the superolateral cortex of each spinous process was the most medial point. RESULTS: When drilling for the C3 and C4 lateral mass screws, the C4 and C5 spinous processes provided an accurate starting point, respectively, for the lateral angle but moderately overestimated the cephalocaudad angle. For C5 and C6 lateral mass screws, the C6 and C7 spinous processes provided an accurate starting point, respectively, for both the lateral and the cephalocaudad angles. CONCLUSION: The spinous processes can be an accurate local anatomic guide for lateral mass screw trajectory and will allow greater safety while drilling before performing laminectomies. These guides may change in patients with cervical spinal deformities.


Asunto(s)
Tornillos Óseos , Fijadores Internos , Laminectomía/métodos , Fusión Vertebral/métodos , Columna Vertebral/anatomía & histología , Cadáver , Vértebras Cervicales , Femenino , Humanos , Masculino
17.
Curr Opin Pediatr ; 17(1): 48-53, 2005 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-15659963

RESUMEN

PURPOSE OF REVIEW: Severe spinal deformity in young children is a formidable challenge for optimal treatment. Standard interventions for adolescents and adults, including spinal deformity correction and fusion, may not be appropriate for young patients with considerable growth remaining. Alternate surgical options that provide deformity correction and protect the growth remaining in the spine are needed to treat this population of patients best. RECENT FINDINGS: Several groups have reported very exciting advances in the field of deformity spine surgery. Updated findings concerning the successful implementation of growing rods have revived this technique as a viable option for preserving near normal growth of the spine. New techniques have also been recently described, including vertebral stapling that produces asymmetric and corrective growth of the concavity of a deformity, and vertical expandable prosthetic titanium rib instrumentation that indirectly corrects spine deformity and protects spine growth remaining to treat an associated thoracic insufficiency syndrome. SUMMARY: New techniques and instrumentation at the disposal of spine surgeons allow the treatment of this challenging patient population to approach the goals of deformity correction and maintenance with preservation of potential growth. Preliminary outcomes from the different techniques are promising, but further investigation, including long-term follow-up, is necessary.


Asunto(s)
Fijadores Internos , Escoliosis/cirugía , Columna Vertebral/cirugía , Grapado Quirúrgico/métodos , Preescolar , Humanos , Columna Vertebral/crecimiento & desarrollo , Toracoplastia/métodos
18.
Spine (Phila Pa 1976) ; 30(18): 2039-44, 2005 Sep 15.
Artículo en Inglés | MEDLINE | ID: mdl-16166892

RESUMEN

STUDY DESIGN: Retrospective analysis of patients treated with single and dual growing rods who had completed their course of treatment, had definitive fusion, and had a minimum of 2 years follow-up. OBJECTIVES: To determine which technique was the most effective in the management of severe spinal deformity in young children: control of the spinal deformity, spinal growth, and the incidence of complications. SUMMARY OF BACKGROUND DATA: Growing rod techniques provide proximal and distal segmental "claw" foundations, but their overall results through definitive fusion have not been clearly determined. METHODS: A total of 28 consecutive patients who had growing rod procedures followed through definitive spinal fusions were analyzed. There were three patient groups: Group 1 (N = 5), single submuscular rod and short apical fusion; Group 2 (N = 16), single growing rod alone; and Group 3 (N = 7), dual growing rods. RESULTS: The interval between initial rod insertion and definitive spinal fusion was similar in all three groups. The best overall results occurred in Group 3, whereas the patients in Group 1 had the worse results. Both Groups 2 and 3 provided good initial correction of the spinal deformity and allowed spinal growth. Group 2 had better frontal and sagittal plane balance and the lowest complication rate. CONCLUSION: The use of growing rods is effective in controlling severe spinal deformities and allowing spinal growth. Dual rods are stronger than single rods and, therefore, provide better initial correction and maintenance of correction. The use of an apical fusion does not appear to be effective over the course of treatment.


Asunto(s)
Clavos Ortopédicos , Cifosis/cirugía , Escoliosis/cirugía , Clavos Ortopédicos/efectos adversos , Niño , Preescolar , Diseño de Equipo , Falla de Equipo , Femenino , Humanos , Cifosis/diagnóstico por imagen , Cifosis/fisiopatología , Masculino , Radiografía , Estudios Retrospectivos , Escoliosis/diagnóstico por imagen , Escoliosis/fisiopatología , Fusión Vertebral , Columna Vertebral/crecimiento & desarrollo , Infección de la Herida Quirúrgica/etiología , Factores de Tiempo , Resultado del Tratamiento
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