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PURPOSE: One of the major advantages of a minimally invasive microdiscectomy is that when CSF leak occurs, there is minimal anatomic dead space for ongoing leakage following removal of the tubular retractor. However, there are no published reports that address the safety and long-term outcomes of same-day discharge for CSF leak after tubular microdiscectomy. METHODS: This is a retrospective compartive study of 30 patients with incidental durotomy during minimally invasive tubular microdiscectomy occurring between January 1, 2009 to August 31, 2023 at our institution. RESULTS: There were 16 patients (53%) admitted to hospital and 14 (47%) patients discharged home the same day following CSF leak. There were no differences in patient demographics between the two groups at baseline. Twenty-nine out of 30 (97%) of the patients had onlay duraplasty, and one (3%) patient was repaired using sutures through the tubular retractor. None were converted to an open approach. The hospitalized group was kept on bed rest overnight or for 24 h. The discharge group was kept on best rest for 2 h or mobilized immediately after surgery. No patients in either group required readmission or revision surgery for CSF leak. The average length of admission for the hospitalized group was 2.4 ± 4.0 days. CONCLUSION: Patients with CSF leak during minimally invasive tubular microdiscectomy can be safely discharged home the same day.
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OBJECTIVE: We examined the impact of consenting to the Rick Hansen Spinal Cord Injury Registry (RHSCIR) on outcomes: acute length of stay (LOS), in-hospital mortality, medical complications (pressure injuries and pneumonia), and the final discharge destination following a spinal cord injury (SCI) using the national RHSCIR dataset. DESIGN: A retrospective cohort study was conducted using RHSCIR participant data from 2014 to 2019. Participants approached for enrollment were grouped into 1) PC: provided full consent including community follow-up (CFU) interviews, 2) DWC: declined CFU interviews but accepted minimal data collection that may include initial/final interviews and/or those who later withdrew consent, and 3) DC: declined consent to any participation. As no data was collected for the DC group, descriptive, bivariate, and multivariable regression analysis was limited to the PC and DWC groups. RESULTS: Of 2811 participants, 2101 (74.7%) were PC, 553 (19.7%) were DWC, and 157 (5.6%) were DC. DWC participants had significantly longer acute LOS, more acute pneumonias/pressure injuries, and were less likely to be discharged home than PC participants. All these associations - except pneumonia - remained significant in the multivariable analyses. CONCLUSION: Not participating fully in RHSCIR was associated with more complications and longer hospital stays.
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Importance: The modified Japanese Orthopaedic Association (mJOA) scale is the most common scale used to represent outcomes of degenerative cervical myelopathy (DCM); however, it lacks consideration for neck pain scores and neglects the multidimensional aspect of recovery after surgery. Objective: To use a global statistical approach that incorporates assessments of multiple outcomes to reassess the efficacy of riluzole in patients undergoing spinal surgery for DCM. Design, Setting, and Participants: This was a secondary analysis of prespecified secondary end points within the Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-PROTECT) trial, a multicenter, double-blind, phase 3 randomized clinical trial conducted from January 2012 to May 2017. Adult surgical patients with DCM with moderate to severe myelopathy (mJOA scale score of 8-14) were randomized to receive either riluzole or placebo. The present study was conducted from July to December 2023. Intervention: Riluzole (50 mg twice daily) or placebo for a total of 6 weeks, including 2 weeks prior to surgery and 4 weeks following surgery. Main Outcomes and Measures: The primary outcome measure was a difference in clinical improvement from baseline to 1-year follow-up, assessed using a global statistical test (GST). The 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS), arm and neck pain numeric rating scale (NRS) scores, American Spinal Injury Association (ASIA) motor score, and Nurick grade were combined into a single summary statistic known as the global treatment effect (GTE). Results: Overall, 290 patients (riluzole group, 141; placebo group, 149; mean [SD] age, 59 [10.1] years; 161 [56%] male) were included. Riluzole showed a significantly higher probability of global improvement compared with placebo at 1-year follow-up (GTE, 0.08; 95% CI, 0.00-0.16; P = .02). A similar favorable global response was seen at 35 days and 6 months (GTE for both, 0.07; 95% CI, -0.01 to 0.15; P = .04), although the results were not statistically significant. Riluzole-treated patients had at least a 54% likelihood of achieving better outcomes at 1 year compared with the placebo group. The ASIA motor score and neck and arm pain NRS combination at 1 year provided the best-fit parsimonious model for detecting a benefit of riluzole (GTE, 0.11; 95% CI, 0.02-0.16; P = .007). Conclusions and Relevance: In this secondary analysis of the CSM-PROTECT trial using a global outcome technique, riluzole was associated with improved clinical outcomes in patients with DCM. The GST offered probability-based results capable of representing diverse outcome scales and should be considered in future studies assessing spine surgery outcomes.
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Vértebras Cervicales , Riluzol , Humanos , Riluzol/uso terapéutico , Masculino , Femenino , Persona de Mediana Edad , Método Doble Ciego , Vértebras Cervicales/cirugía , Anciano , Enfermedades de la Médula Espinal/cirugía , Enfermedades de la Médula Espinal/tratamiento farmacológico , Espondilosis/cirugía , Espondilosis/tratamiento farmacológico , Resultado del Tratamiento , Fármacos Neuroprotectores/uso terapéuticoRESUMEN
STUDY DESIGN: Retrospective cohort study of prospectively accrued data. OBJECTIVE: To evaluate a large, prospective, multicentre dataset of surgically treated degenerative cervical myelopathy (DCM) cases on the contemporary risk of C5 palsy with surgical approach. SUMMARY OF BACKGROUND DATA: The influence of surgical technique on postoperative C5 palsy after decompression for DCM is intensely debated. Comprehensive, covariate-adjusted analyses are needed using contemporary data. METHODS: Patients with moderate to severe DCM were prospectively enrolled in the multicenter, randomized, Phase III CSM-Protect clinical trial and underwent either anterior or posterior decompression between Jan 31, 2012 and May 16, 2017. The primary outcome was the incidence of postoperative C5 palsy, defined as the onset of muscle weakness by at least one grade in manual muscle test at the C5 myotome with slight or absent sensory disruption after cervical surgery. Two comparative cohorts were made based on the anterior or posterior surgical approach. Multivariate hierarchical mixed-effects logistic regression was used to estimate odds ratios (OR) with 95% confidence intervals (CI) for C5 palsy. RESULTS: A total of 283 patients were included, and 53.4% underwent posterior decompression. The total incidence of postoperative C5 palsy was 7.4% and was significantly higher in patients who underwent posterior decompression compared with anterior decompression (11.26% vs. 3.03%, P =0.008). After multivariable regression, the posterior approach was independently associated with greater than four times the likelihood of postoperative C5 palsy ( P =0.017). Rates of C5 palsy recovery were comparable between the two surgical approaches. CONCLUSION: The odds of postoperative C5 palsy are significantly higher after posterior decompression compared to anterior decompression for DCM. This may influence surgical decision-making when there is equipoise in deciding between anterior and posterior treatment options for DCM. LEVEL OF EVIDENCE: Therapeutic Level-II.
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Vértebras Cervicales , Descompresión Quirúrgica , Parálisis , Complicaciones Posoperatorias , Humanos , Descompresión Quirúrgica/métodos , Descompresión Quirúrgica/efectos adversos , Masculino , Femenino , Persona de Mediana Edad , Vértebras Cervicales/cirugía , Anciano , Estudios Prospectivos , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiología , Parálisis/etiología , Parálisis/cirugía , Estudios Retrospectivos , Enfermedades de la Médula Espinal/cirugía , Adulto , Resultado del TratamientoAsunto(s)
Vértebras Cervicales , Discectomía , Medición de Resultados Informados por el Paciente , Radiculopatía , Fusión Vertebral , Humanos , Discectomía/métodos , Discectomía/efectos adversos , Fusión Vertebral/efectos adversos , Fusión Vertebral/métodos , Radiculopatía/cirugía , Radiculopatía/etiología , Vértebras Cervicales/cirugía , Factores de Tiempo , Resultado del TratamientoRESUMEN
STUDY DESIGN: Retrospective cohort study. OBJECTIVE: To investigate the impact of long symptom duration (>24 mo) on patient self-reported outcomes for pain, function, and quality of life following anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. SUMMARY OF BACKGROUND DATA: ACDF is an effective treatment to relieve the symptoms of cervical radiculopathy. However, there is no consensus on whether prolonged preoperative length of symptoms negatively impacts postoperative outcomes. METHODS: This study included consecutive patients who underwent ACDF for cervical radiculopathy from May 1, 2012 to Dec 1, 2019 by a single surgeon. Patients were stratified by short (<24 mo) and long (>24 mo) duration of symptoms. Outcomes including visual analog scale (VAS) neck and arm, neck disability index (NDI), EuroQol-5D (EQ-5D), and overall state of health (EQ-VAS) were compared between cohort both for absolute values and percentage of patients achieving minimal clinically important difference. RESULTS: A total of 111 consecutive patients were included in our study, including 59 patients in the short symptom duration group and 52 patients in the long symptom duration group. The mean age of the patients was 51.4±9.4 and 41 (36.9%) were female. The baseline VAS neck and arm, NDI, EQ-5D, and EQ-VAS were similar between groups. Patients in both long and short symptom duration groups had clinical improvement following surgery. However, patients with short symptom duration had better VAS Neck and EQ-5D outcomes, and were more likely to meet minimal clinically important difference for NDI, EQ-5D, or any outcome. Multivariate analysis confirmed symptom duration <24 months as an independent predictor for better patient-reported outcomes. CONCLUSION: We appreciated better clinical outcomes in patients with shorter symptom duration who received ACDF for cervical radiculopathy. On the basis of this data, we advocate for prompt treatment of cervical radiculopathy to avoid the potential for long-term impairment. LEVEL OF EVIDENCE: Level 3.
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Radiculopatía , Fusión Vertebral , Humanos , Femenino , Masculino , Radiculopatía/cirugía , Calidad de Vida , Estudios Retrospectivos , Vértebras Cervicales/cirugía , Discectomía , Resultado del Tratamiento , Medición de Resultados Informados por el Paciente , Fusión Vertebral/efectos adversos , Dolor de Cuello/cirugíaRESUMEN
BACKGROUND: Bilateral occipital condyle fractures (OCFs) with involvement of the inferior clivus, otherwise known as "avulsion of the anterior foramen magnum," are an exceedingly rare injury with only a few published reports. OBSERVATIONS: A 24-year-old male presented with bilateral OCFs with involvement of the clivus after a motor vehicle accident. The patient had no neurological deficits and was successfully managed nonoperatively using a halo vest. The authors used a traction test to guide the duration of nonoperative care. The operative and nonoperative management of this rare injury is discussed with respect to other cases in the literature. LESSONS: External immobilization through a halo vest is an effective treatment option for bilateral OCFs with clivus involvement. The traction test can be used, along with computed tomography, to guide the duration of treatment.
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OBJECTIVE: Length of stay (LOS) is a contributor to costs and resource utilization. The primary goal of this study was to identify patient, clinical, surgical, and institutional variables that influence LOS after elective surgery for thoracolumbar degenerative pathology. The secondary objective was to examine variability in LOS and institutional strategies used to decrease LOS. METHODS: This is a retrospective study of prospectively collected data from a multicentric cohort enrolled in the Canadian Spine Outcomes and Research Network (CSORN) between January 2015 and October 2020 who underwent elective thoracolumbar surgery (discectomy [1 or 2 levels], laminectomy [1 or 2 levels], and posterior instrumented fusion [up to 5 levels]). Prolonged LOS was defined as LOS greater than the median. Logistic regression models were used to determine factors associated with prolonged LOS for each procedure. A survey was sent to the principal investigators of the participating healthcare institutions to understand institutional practices that are used to decrease LOS. RESULTS: A total of 3700 patients were included (967 discectomies, 1094 laminectomies, and 1639 fusions). The median LOSs for discectomy, laminectomy, and fusion were 0.0 (IQR 1.0), 1.0 (IQR 2.0), and 4.0 (IQR 2.0) days, respectively. On multivariable analysis, predictors of prolonged LOS for discectomy were having more leg pain, higher Oswestry Disability Index (ODI) scores, symptom duration more than 2 years, having undergone an open procedure, occurrence of an adverse event (AE), and treatment at an institution without protocols to reduce LOS (p < 0.05). Predictors of prolonged LOS for laminectomy were increased age, living alone, higher ODI scores, higher BMI, open procedures, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). For posterior instrumented fusion, predictors of prolonged LOS were older age, living alone, more comorbidities, higher ODI scores, longer operative time, AEs, and treatment at an institution without protocols to reduce LOS (p < 0.05). The laminectomy group had the largest variability in LOS (SD 4.4 days, range 0-133 days). Three hundred fifty-four patients (22%) had an LOS above the 75th percentile. Ten institutions (53%) had either Enhanced Recovery After Surgery or standardized protocols in place. CONCLUSIONS: Among the factors identified in this study, worse baseline ODI scores, experiencing AEs, and treatment at an institution without protocols aimed at reducing LOS were predictive of prolonged LOS in all surgical groups. The laminectomy group had the largest variability in LOS.
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Vértebras Lumbares , Fusión Vertebral , Humanos , Vértebras Lumbares/cirugía , Estudios Retrospectivos , Tiempo de Internación , Resultado del Tratamiento , Fusión Vertebral/métodos , Canadá/epidemiologíaRESUMEN
PURPOSE: "After-hours" non-elective spine surgery is associated with increased morbidity. Decision-making may be enhanced by collaborative input from experienced local colleagues. At our center, we implemented routine use of a cross-platform messaging system (CPMS; WhatsApp Inc., Mountain View, California) to facilitate quality care discussions and collaborative surgical decision-making between spine surgeons prior to booking cases with the operating room. Our aim is to determine whether encrypted text messaging for shared decision-making between spine surgeons affects the number or type of after-hours spine procedures. METHODS: We retrospectively compared the number, type and length of after-hours spine surgery over three time periods: (A) June 1, 2016-May 31, 2017 (baseline control); (B) June 1, 2017-May 31, 2018 (implementation of retrospective quality care spine rounds); and (C) June 1, 2018-May 31, 2019 (implementation of CPMS). A qualitative analysis of the CPMS transcripts was also performed to assess the rate of between-surgeon agreement for timing and type of procedure. RESULTS: The mean number of after-hours spine surgeries/month over the three study periods (A, B, C) was 10.83, 9.75 and 7.58 (p = 0.014); length of surgery was 41.82, 33.14 and 25.37 h/month (p = 0.001). Group agreement with the attending spine surgeon plan was 74.3% overall and was highest for the most urgent and least urgent types of indications. CONCLUSIONS: Prospective (i.e., prior to booking surgery) quality care discussion for joint decision-making among spine surgeons using CPMS may reduce both the number and complexity of after-hours procedures.
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Columna Vertebral , Cirujanos , Humanos , Estudios Retrospectivos , Estudios Prospectivos , Columna Vertebral/cirugía , QuirófanosRESUMEN
Systemic assessment is a pillar in the neurological, oncological, mechanical, and systemic (NOMS) decision-making framework for the treatment of patients with spinal metastatic disease. Despite this importance, emerging evidence relating systemic considerations to clinical outcomes following surgery for spinal metastatic disease has not been comprehensively summarised. We aimed to conduct a scoping literature review of this broad topic. We searched MEDLINE, Embase, Scopus, Cochrane Central Register of Controlled Trials, Web of Science, and CINAHL databases from Jan 1, 2000, to July 31, 2021. 61 articles were included, accounting for a total of 22â335 patients. Preoperative systemic variables negatively associated with postoperative clinical outcomes included demographics (eg, older age [>60 years], Black race, male sex, low or elevated body-mass index, and smoking status), medical comorbidities (eg, cardiac, pulmonary, hepatic, renal, endocrine, vascular, and rheumatological), biochemical abnormalities (eg, hypoalbuminaemia, atypical blood cell counts, and elevated C-reactive protein concentration), low muscle mass, generalised motor weakness (American Spinal Cord Injury Association Impairment Scale grade and Frankel grade) and poor ambulation, reduced performance status, and systemic disease burden. This is the first comprehensive scoping review to broadly summarise emerging evidence relevant to the systemic assessment component of the widely used NOMS framework for spinal metastatic disease decision making. Medical, surgical, and radiation oncologists can consider these findings when prognosticating spinal metastatic disease-related surgical outcomes on the basis of patients' systemic condition. These factors might inform a shared decision-making approach with patients and their families.
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Metástasis de la Neoplasia , Neoplasias de la Médula Espinal , Femenino , Humanos , Masculino , Neoplasias de la Médula Espinal/terapiaRESUMEN
PURPOSE: Surgical indications for lumbar spinal stenosis are controversial, but most agree that leg dominant pain is a better predictor of success after decompression surgery. The objective of this study is to analyze the ability of the Nerve Root Sedimentation Sign (SedSign) on MRI to differentiate leg dominant symptoms from non-specific low back pain. METHODS: This was a retrospective review of 367 consecutive patients presenting with back and/or leg pain. Baseline clinical characteristics included Oswestry disability index (ODI), visual analog pain scores, EuroQol Group 5-Dimension Self-Report (EQ5D) and Saskatchewan Spine Pathway Classification (SSPc). Inter- and intra-rater reliability for SedSign was 73% and 91%, respectively (3 examiners). RESULTS: SedSign was positive in 111 (30.2%) and negative in 256 (69.8%) patients. On univariate analysis, a positive SedSign was correlated with age, male sex, several ODI components, EQ5D mobility, cross-sectional area (CSA) of stenosis, antero-posterior diameter of stenosis, and SSPc pattern 4 (intermittent leg dominant pain). On multivariate analysis, SedSign was associated with age, male sex, CSA stenosis and ODI walking distance. Patients with a positive SedSign were more likely to be offered surgery after referral (OR 2.65). The sensitivity and specificity for detecting all types of leg dominant pain were 37.4 and 82.8, respectively (ppv 77.5%, npv 43.8%). CONCLUSIONS: Patients with a positive SedSign were more likely to be offered surgery, in particular non-instrumented decompression. The SedSign has high specificity for leg dominant pain, but the sensitivity is poor. As such, its use in triaging appropriate surgical referrals is limited.
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Estenosis Espinal , Triaje , Descompresión Quirúrgica , Humanos , Pierna , Vértebras Lumbares/diagnóstico por imagen , Vértebras Lumbares/cirugía , Imagen por Resonancia Magnética , Masculino , Reproducibilidad de los Resultados , Estudios Retrospectivos , Estenosis Espinal/diagnóstico por imagen , Estenosis Espinal/cirugíaRESUMEN
BACKGROUND: despite the efforts of multiple stakeholders to promote appropriate care throughout the healthcare system, studies show that two out of three lower back pain (LBP) patients expect to receive imaging. We used the Choosing Wisely Canada patient-oriented framework, prioritizing patient engagement, to develop an intervention that addresses lower back pain imaging overuse. METHODS: to develop this intervention, we collaborated with a multidisciplinary advisory team, including two patient partners with lower back pain, researchers, clinicians, healthcare administrators, and the Choosing Wisely Canada lead for Saskatchewan. For this qualitative study, data were collected through two advisory team meetings, two individual interviews with lower back pain patient partners, and three focus groups with lower back pain patient participants. A lower back pain prescription pad was developed as an outcome of these consultations. RESULTS: participants reported a lack of interactive and informative communication was a significant barrier to receiving appropriate care. The most cited content information for inclusion in this intervention was treatments known to work, including physical activity, useful equipment, and reliable sources of educational material. Participants also suggested it was important that benefits and risks of imaging were explained on the pad. Three key themes derived from the data were also used to guide development of the intervention: (a) the role of imaging in LBP diagnosis; (b) the impact of the patient-physician relationship on LBP diagnosis and treatment; and (c) the lack of patient awareness of Choosing Wisely Canada and their recommendations. CONCLUSIONS: the lower back pain patient-developed prescription pad may help patients and clinicians engage in informed conversations and shared decision making that could support reduce unnecessary lower back pain imaging.
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Dolor de la Región Lumbar , Comunicación , Toma de Decisiones Conjunta , Humanos , Dolor de la Región Lumbar/terapia , Relaciones Médico-Paciente , SaskatchewanRESUMEN
Acute traumatic spinal cord injury (SCI) can result in severe, lifelong neurological deficits. After SCI, Rho activation contributes to collapse of axonal growth cones, failure of axonal regeneration, and neuronal loss. This randomized, double-blind, placebo-controlled phase 2b/3 study evaluated the efficacy and safety of Rho inhibitor VX-210 (9 mg) in patients after acute traumatic cervical SCI. The study enrolled patients 14-75 years of age with acute traumatic cervical SCIs, C4-C7 (motor level) on each side, and American Spinal Injury Association Impairment Scale (AIS) Grade A or B who had spinal decompression/stabilization surgery commencing within 72 h after injury. Patients were randomized 1:1 with stratification by age (<30 vs. ≥30 years) and AIS grade (A vs. B with sacral pinprick preservation vs. B without sacral pinprick preservation). A single dose of VX-210 or placebo in fibrin sealant was administered topically onto the dura over the site of injury during decompression/stabilization surgery. Patients were evaluated for medical, neurological, and functional changes, and serum was collected for pharmacokinetics and immunological analyses. Patients were followed up for up to 12 months after treatment. A planned interim efficacy-based futility analysis was conducted after â¼33% of patients were enrolled. The pre-defined futility stopping rule was met, and the study was therefore ended prematurely. In the final analysis, the primary efficacy end-point was not met, with no statistically significant difference in change from baseline in upper-extremity motor score at 6 months after treatment between the VX-210 (9-mg) and placebo groups. This work opens the door to further improvements in the design and conduct of clinical trials in acute SCI.
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Médula Cervical/lesiones , Inhibidores Enzimáticos/uso terapéutico , Traumatismos de la Médula Espinal/tratamiento farmacológico , Quinasas Asociadas a rho/antagonistas & inhibidores , Quinasas Asociadas a rho/uso terapéutico , ADP Ribosa Transferasas , Adolescente , Adulto , Anciano , Toxinas Botulínicas , Vértebras Cervicales , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Recuperación de la Función , Resultado del Tratamiento , Adulto JovenRESUMEN
PURPOSE: Low back pain (LBP) is a major public health problem worldwide. Significant practice variation exists despite guidelines, including strong interventionist focus by some practitioners. Translation of guidelines into pathways as integrated treatment plans is a next step to improve implementation. The goal of the present study was to analyze international examples of LBP pathways in order to identify key interventions as building elements for care pathway for LBP and radicular pain. METHODS: International examples of LBP pathways were searched in literature and grey literature. Authors of pathways were invited to fill a questionnaire and to participate in an in-depth telephone interview. Pathways were quantitatively and qualitatively analyzed, to enable the identification of key interventions to serve as pathway building elements. RESULTS: Eleven international LBP care pathways were identified. Regional pathways were strongly organized and included significant training efforts for primary care providers and an intermediate level of caregivers in between general practitioners and hospital specialists. Hospital pathways had a focus on multidisciplinary collaboration and stepwise approach trajectories. Key elements common to all pathways included the consecutive screening for red flags, radicular pain and psychosocial risk factors, the emphasis on patient empowerment and self-management, the development of evidence-based consultable protocols, the focus on a multidisciplinary work mode and the monitoring of patient-reported outcome measures. CONCLUSION: Essential building elements for the construction of LBP care pathways were identified from a transversal analysis of key interventions in a study of 11 international examples of LBP pathways.
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Dolor de la Región Lumbar , Personal de Salud , Humanos , Medición de Resultados Informados por el Paciente , Encuestas y CuestionariosRESUMEN
BACKGROUND: Degenerative cervical myelopathy represents the most common form of non-traumatic spinal cord injury. This trial investigated whether riluzole enhances outcomes in patients undergoing decompression surgery for degenerative cervical myelopathy. METHODS: This multicentre, double-blind, placebo-controlled, randomised, phase 3 trial was done at 16 university-affiliated centres in Canada and the USA. Patients with moderate-to-severe degenerative cervical myelopathy aged 18-80 years, who had a modified Japanese Orthopaedic Association (mJOA) score of 8-14, were eligible. Patients were randomly assigned (1:1) to receive either oral riluzole (50 mg twice a day for 14 days before surgery and then for 28 days after surgery) or placebo. Randomisation was done using permuted blocks stratified by study site. Patients, physicians, and outcome assessors remained masked to treatment group allocation. The primary endpoint was change in mJOA score from baseline to 6 months in the intention-to-treat (ITT) population, defined as all individuals who underwent randomisation and surgical decompression. Adverse events were analysed in the modified intention-to-treat (mITT) population, defined as all patients who underwent randomisation, including those who did not ultimately undergo surgical decompression. This study is registered with ClinicalTrials.gov, NCT01257828. FINDINGS: From Jan 31, 2012, to May 16, 2017, 408 patients were screened. Of those screened, 300 were eligible (mITT population); 290 patients underwent decompression surgery (ITT population) and received either riluzole (n=141) or placebo (n=149). There was no difference between the riluzole and placebo groups in the primary endpoint of change in mJOA score at 6-month follow-up: 2·45 points (95% CI 2·08 to 2·82 points) versus 2·83 points (2·47 to 3·19), difference -0·38 points (-0·90 to 0·13; p=0·14). The most common adverse events were neck or arm or shoulder pain, arm paraesthesia, dysphagia, and worsening of myelopathy. There were 43 serious adverse events in 33 (22%) of 147 patients in the riluzole group and 34 serious adverse events in 29 (19%) of 153 patients in the placebo group. The most frequent severe adverse events were osteoarthrosis of non-spinal joints, worsening of myelopathy, and wound complications. INTERPRETATION: In this trial, adjuvant treatment for 6 weeks perioperatively with riluzole did not improve functional recovery beyond decompressive surgery in patients with moderate-to-severe degenerative cervical myelopathy. Whether riluzole has other benefits in this patient population merits further study. FUNDING: AOSpine North America.
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Vértebras Cervicales/cirugía , Craniectomía Descompresiva/métodos , Degeneración del Disco Intervertebral/tratamiento farmacológico , Degeneración del Disco Intervertebral/cirugía , Fármacos Neuroprotectores/uso terapéutico , Procedimientos Neuroquirúrgicos/métodos , Riluzol/uso terapéutico , Compresión de la Médula Espinal/tratamiento farmacológico , Compresión de la Médula Espinal/cirugía , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Terapia Combinada , Método Doble Ciego , Determinación de Punto Final , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fármacos Neuroprotectores/efectos adversos , Dolor Postoperatorio/epidemiología , Riluzol/efectos adversos , Resultado del TratamientoRESUMEN
STUDY DESIGN: Single-center prospective non-randomized matched cohort comparison. OBJECTIVE: To compare elective lumbar spine surgery outcomes for cases triaged through a multidisciplinary spine pathway versus conventional referral processes. SUMMARY OF BACKGROUND DATA: Many health care systems have facilitated low back pain (LBP) guidelines into primary care practice by creating local or regional "pathways" with the goal of enhanced quality of care, improved patient satisfaction and optimal resource utilization, particularly for imaging and surgery. Few comparative outcomes exist for LBP pathways, particularly for surgical outcomes. METHODS: One-hundred-fifty patients (SSP group nâ=â75; conventional group nâ=â75) undergoing elective lumbar surgery for degenerative conditions between 2011 and 2016 were analyzed with 1-year follow-up. Patient self-reported outcomes included the Oswestry disability index (ODI), visual analogue pain scores (VAS) for back and leg, and EuroQol Group 5-Dimension self-report (EQ-5D). We also assessed baseline clinical features, indications for surgery, therapies received prior to surgery, type of surgery, wait times, and overall patient satisfaction. RESULTS: The groups had equivalent baseline demographics, body mass index, Saskatchewan Spine Pathway (SSP) classification of pain pattern, pain scores, functional scores, quality of life scores, indication for surgery, and type of surgery (instrumented or non-instrumented). There was no difference with respect to wait times to see the surgeon or for surgery. Wait time for magnetic resonance imaging (MRI) was significantly shorter for the SSP group (16.8 vs. 63.0 days, Pâ<â0.001). Patients triaged through the SSP were significantly more likely to utilize multiple nonoperative treatment strategies prior to seeing the surgeon (Pâ<â0.04). Patient satisfaction was significantly higher for SSP patients prior to surgical assessment (Pâ=â0.03) but did not differ between groups after surgery. CONCLUSION: The SSP facilitates significantly shorter wait times for MRI and promotes nonoperative treatment strategies. Preoperative patient satisfaction is significantly higher among SSP patients, but there were no significant differences in surgical outcomes.Level of Evidence: 3.
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Procedimientos Quirúrgicos Electivos/métodos , Dolor de la Región Lumbar/cirugía , Vértebras Lumbares/cirugía , Medición de Resultados Informados por el Paciente , Triaje/métodos , Adulto , Anciano , Estudios de Cohortes , Procedimientos Quirúrgicos Electivos/psicología , Femenino , Humanos , Dolor de la Región Lumbar/diagnóstico , Dolor de la Región Lumbar/psicología , Masculino , Persona de Mediana Edad , Procedimientos Neuroquirúrgicos/métodos , Procedimientos Neuroquirúrgicos/psicología , Dimensión del Dolor/métodos , Dimensión del Dolor/psicología , Satisfacción del Paciente , Estudios Prospectivos , Calidad de Vida/psicología , Derivación y Consulta , Resultado del TratamientoRESUMEN
BACKGROUND: Evoked electromyographic (EMG) monitoring of pedicle screws has been shown to be an effective adjuvant to image guidance or direct visualization of pedicle screw placement. Electrical stimulation is delivered to the head of the screw at various intensities until a muscle potential is evoked. This practice is based on the fact that an intact pedicle effectively shields nerve roots from electrical stimulus. Several factors have been debated that may affect the interpretation of results; however, to the best of our knowledge, the electrical resistance of modern manufactured pedicle screws and stimulation devices has not been studied. OBJECTIVE: To determine if pedicle screw resistances affect triggered EMG. METHODS: Samples of the most commonly implanted pedicle screws in Canada were obtained, with diameters ranging from 4.5 to 7 mm. The resistance between the screw head and thread and core at the midpoint and tip of the screw was recorded using a Multimeter in accordance with IEEE standards. For screws with variable threads, the midpoint was considered the point at which the thread pitch changed. RESULTS: All screws had low impedances when tested at the point of the screw, but much higher when the cup is tested. The resistance of different manufactures' screws was significantly different, ranging from 0.514 to 2156 Ohms. CONCLUSION: Despite differences in resistance, most screws had resistances in ranges that allow for triggered EMG pedicle integrity testing. Resistance from pedicle screws is an important consideration in EMG monitoring of the spine.