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Background: The recommended treatment for cervical spinal cord injury (cSCI) is surgical decompression and stabilization within 24 h after injury. The aims of the study were to estimate our institutional compliance with this recommendation and identify potential factors associated with surgical delay. Methods: Population-based retrospective database study of patients operated for cSCI in 2015-2022 within the South-East Norway Health Region (3.1 million inhabitants). Data extracted were demographics, injury description, management timeline, place of primary triage [local hospital (LH) or neurotrauma center (NTC)]. Main outcome variables were: (1) time from injury to surgery at NTC, (2) time from injury to admission NTC, and (3) time from admission NTC to surgery. Results: We found 243 cSCI patients having acute neck surgery. Their median age was 63 years (IQR 47-74 years), 77% were male, 48% were ≥65 years old. Primary triage at an LH occurred in 150/243 (62%). The median time from injury to acute surgery was 27.8 h (IQR 15.4-61.9 h), and 47% had surgery within 24 h. The median time from injury to NTC admission was 5.6 h (IQR 1.9-19.4 h), and 67% of the patients were admitted to the NTC within 12 h. Significant factors associated with increased time from injury to NTC admission were transfer via LH, severe preinjury comorbidities, less severe cSCI, time of injury other than night, absence of multiple injuries. The median time from NTC admission to surgery was 16.7 h (IQR 9.5-31.0 h), and 70% had surgery within 24 h. Significant factors associated with increased time from NTC admission to surgery were increasing age and non-translational injury morphology. Conclusion: Less than half of the patients with cSCI were operated on within the recommended 24 h time frame after injury. To increase the fraction of early surgery, we suggest the following: (1) patients with clinical suspicion of cSCI should be transported directly to the NTC from the scene of the accident, (2) MRI should be performed only at the NTC, (3) at the NTC, surgery should commence on the same calendar day as arrival or as the first operation the following day.
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Pressure monitoring in various organs of the body is essential for appropriate diagnostic and therapeutic purposes. In almost all situations, monitoring is performed in a hospital setting. Technological advances not only promise to improve clinical pressure monitoring systems, but also engage toward the development of fully implantable systems in ambulatory patients. Such systems would not only provide longitudinal time monitoring to healthcare personnel, but also to the patient who could adjust their way-of-life in response to the measurements. In the past years, we have developed a new type of piezoresistive pressure sensor system. Different bench tests have demonstrated that it delivers precise and reliable pressure measurements in real-time. The potential of this system was confirmed by a continuous recording in a patient that lasted for almost a day. In the present study, we further characterized the functionality of this sensor system by conducting in vivo implantation experiments in nine female farm pigs. To get a step closer to a fully implantable system, we also adapted two different wireless communication solutions to the sensor system. The communication protocols are based on MICS (Medical Implant Communication System) and BLE (Bluetooth Low Energy) communication. As a proof-of-concept, implantation experiments in nine female pigs demonstrated the functionality of both systems, with a notable technical superiority of the BLE.
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Computadores , Prótesis e Implantes , Humanos , Femenino , Animales , Porcinos , Monitoreo Fisiológico/métodosRESUMEN
Concussion is common and usually resolves without complications. However, persistent symptoms occur in 10-15 % of patients. These post-concussion symptoms are predominantly somatic, cognitive and emotional. The condition is most common in those with previous somatic and mental health issues. The causes underlying long-term post-concussion symptoms are unclear, but a biopsychosocial explanatory model is currently regarded as the most appropriate basis for diagnosis and treatment. This clinical review article is based on key literature and our own clinical experiences with patients who have these long-term post-concussion symptoms.
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Conmoción Encefálica , Síndrome Posconmocional , Conmoción Encefálica/complicaciones , Conmoción Encefálica/diagnóstico , Conmoción Encefálica/terapia , Humanos , Síndrome Posconmocional/diagnóstico , Síndrome Posconmocional/etiología , Síndrome Posconmocional/terapiaRESUMEN
BACKGROUND: In Western countries, the typical cervical spine fracture (CS-Fx) patient has historically been a young male injured in a road traffic accident. Recent reports and daily clinical practice clearly indicate a change in the typical patient from a young male to an elderly male or female with comorbidities. This study aimed to establish contemporary population-based epidemiological data of traumatic CS-Fx for use in health-care planning and injury prevention. METHODS: This is a population-based retrospective database study (with prospectively collected data) from the Southeast Norway health region with 3.0 million inhabitants. We included all consecutive cases diagnosed with a CS-Fx between 2015 and 2019. Information regarding demographics, preinjury comorbidities, trauma mechanisms, injury description, treatment, and level of hospital admittance is presented. RESULTS: We registered 2153 consecutive cases with CS-Fx during a 5-year period, with an overall crude incidence of CS-Fx of 14.9/100,000 person-years. Age-adjusted incidences using the standard population for Europe and the World was 15.6/100,000 person-years and 10.4/100,000 person-years, respectively. The median patient age was 62 years, 68% were males, 37% had a preinjury severe systemic disease, 16% were under the influence of ethanol, 53% had multiple trauma, and 12% had concomitant cervical spinal cord injury (incomplete in 85% and complete in 15%). The most common trauma mechanisms were falls (57%), followed by bicycle injuries (12%), and four-wheel motorized vehicle accidents (10%). The most common upper CS-Fx was C2 odontoid Fx, while the most common subaxial Fx was facet joint Fx involving cervical level C6/C7. Treatment was external immobilization with a stiff neck collar alone in 65%, open surgical fixation in 26% (giving a 3.7/100,000 person-years surgery rate), and no stabilization in 9%. The overall 90-day mortality was 153/2153 (7.1%). CONCLUSIONS: This study provides an overview of the extent of the issue and patient complexity necessary for planning the health-care management and injury prevention of CS-Fx. The typical CS-Fx patient was an elderly male or female with significant comorbidities injured in a low-energy trauma. The overall crude incidences of CS-Fx and surgical fixation of CS-Fx in Southeast Norway were 14.9/100,000 person-years and 3.7/100,000 person-years, respectively.
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BACKGROUND: Transanal irrigation (TAI) has emerged as a key option when more conservative bowel management does not help spinal cord injured (SCI) individuals with neurogenic bowel dysfunction (NBD). AIM: To investigate the short-term efficacy and safety of an electronic TAI system (Navina Smart) in subjects with NBD. DESIGN: We present an open, prospective efficacy study on Navina Smart, in individuals with NBD secondary to SCI, studied at three months. POPULATION: Eighty-nine consecutive consenting established SCI individuals (61 male; mean age 48, range 18-77) naïve to TAI treatment were recruited from ten centres in seven countries. Subjects had confirmed NBD of at least moderate severity (NBD score ≥10). METHODS: Subjects were taught how to use the device at baseline assisted by the Navina Smart app, and treatment was tailored during phone calls until optimal TAI regime was achieved. The NBD score was measured at baseline and at three months follow up (mean 98 days). Safety analysis was performed on the complete population while per protocol (PP) analysis was performed on 52 subjects. RESULTS: PP analysis showed a significant decrease in mean NBD score (17.8 to 10, p<0.00001). In subjects with severe symptoms (defined as NBD score ≥14), mean NBD scores decreased (19.4 to 10.9, p<0.0001). The number of subjects with severe symptoms decreased from 41 (79%) subjects at baseline to 16 (31%) at three months follow-up. Device failure accounted for the commonest cause for loss of data. Side effects possibly related to the device developed in 11 subjects (12%). Discontinuation due to failure of therapy to relieve symptoms was reported by 5 subjects (6%). CONCLUSION: Navina Smart is effective for individuals with NBD, even those with severe symptoms; long-term data will follow. Whilst there were some device problems (addressed by the later stages of subject recruitment) the treatment was generally safe. CLINICAL TRIAL: (ClinicalTrials.gov number NCT02979808).
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Intestino Neurogénico/terapia , Irrigación Terapéutica/métodos , Adulto , Diseño de Equipo , Incontinencia Fecal/etiología , Incontinencia Fecal/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intestino Neurogénico/etiología , Estudios Prospectivos , Traumatismos de la Médula Espinal/complicaciones , Irrigación Terapéutica/efectos adversos , Irrigación Terapéutica/instrumentaciónRESUMEN
BACKGROUND: European and Norwegian consensus-based guidelines for the management of acute low back pain endorse red flag screening. Red flag symptomatology may ignore important information in the case history and clinical findings. CASE PRESENTATION: An active man in his sixties presented with acute low back pain with radiation to the left thigh. A paramedic visited the patient at home and found no serious disease. Over a period of 4 hours, progressive loss of sensation and weakness in both legs developed. He arrived at the Accident and Emergency Department with paralysis, reduced sensation distal to the hips, absent reflexes, urinary retention and reduced sphincter tone. INR was 2.6. MR scan showed an intradural haematoma compressing Th9-L1, and dislocation of medulla and conus. This was followed by urgent Th10-12 laminectomy and evacuation of subdural haematoma, and thereafter rehabilitation. Three years later, he has sequelae for spinal cord injury at level Th12 with impaired mobility and function in the legs. INTERPRETATION: This case highlights that patients with ongoing anticoagulation and acute back pain have increased risk of spinal haematoma requiring emergency treatment. Anticoagulation therapy should therefore be included in red flag screening of acute back pain.
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Dolor de Espalda , Parálisis , Humanos , Extremidad Inferior/diagnóstico por imagen , Imagen por Resonancia Magnética , MasculinoRESUMEN
STUDY DESIGN: Health-related quality of life (HRQOL) data from two parallel independent single-blinded controlled randomized studies of manual (Study 1) and robotic (Study 2) locomotor training were combined (ClinicalTrials.gov #NCT00854555). OBJECTIVE: To assess effects of body-weight supported locomotor training (BWSLT) programs on HRQOL in persons with long-standing motor incomplete spinal cord injury and poor walking function. SETTINGS: Two inpatient rehabilitation facilities and one outpatient clinic in Norway. METHODS: Data were merged into intervention (locomotor training 60 days) or control group ("usual care"). Participants completed questionnaires before randomization and 2-4 weeks after the study period, including demographic characteristics, HRQOL (36-Item Short-Form Health Status Survey, SF-36), physical activity (The International Physical Activity Questionnaire Short Form, IPAQ-SF), exercise barrier self-efficacy (EBSE), and motivation for training (Behavioral Regulation in Exercise Questionnaire, BREQ). Physical outcomes i.e., Lower extremity motor score (LEMS) was assessed. The main outcome was change in HRQOL. Secondary outcomes included changes in IPAQ-SF, EBSE, BREQ, and physical outcomes. RESULTS: We recruited 37 of 60 predetermined participants. They were autonomously motivated with high baseline physical activity. BWSLT with manual or robot assistance did not improve HRQOL, though LEMS increased in the BWSLT group compared with control group. CONCLUSIONS: The study was underpowered due to recruitment problems. The training programs seem to benefit LEMS, but not other physical outcomes, and had minimal effects on HRQOL, EBSE, and motivation. Autonomous motivation and high physical activity prior to the study possibly limited the attainable outcome benefits, in addition to limitations due to poor baseline physical function.
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Terapia por Ejercicio , Locomoción/fisiología , Rehabilitación Neurológica , Traumatismos de la Médula Espinal/fisiopatología , Traumatismos de la Médula Espinal/rehabilitación , Adulto , Anciano , Terapia por Ejercicio/métodos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Rehabilitación Neurológica/métodos , Noruega , Evaluación de Resultado en la Atención de Salud , Calidad de Vida , Método Simple Ciego , Adulto JovenRESUMEN
BACKGROUND: Systems for monitoring effectiveness and quality of rehabilitation services across health care levels are needed. The purpose of this study was to develop and pilot test a quality indicator set for rehabilitation of rheumatic and musculoskeletal diseases. METHODS: The set was developed according to the Rand/UCLA Appropriateness Method, which integrates evidence review, in-person multidisciplinary expert panel meetings and repeated anonymous ratings for consensus building. The quality indicators were pilot-tested for overall face validity and feasibility in 15 specialist and 14 primary care rehabilitation units. Pass rates (percentages of "yes") of the indicators were recorded in telephone interviews with 29 unit managers (structure indicators), and 164 patients (process and outcome indicators). Time use and participants' numeric rating of face validity (0-10, 10 = high validity) were recorded. RESULTS: Nineteen structure, 12 process and five outcome indicators were developed and piloted. Mean (range) sum pass rates for the structure, process and outcome indicators were 59%(84%), 66%(100%) and 84%(100%), respectively. Mean (range) face validity score for managers/patients was 8.3 (8)/7.9 (9), and mean answering time was 6.0/5.5 min. The final indicator set consists of 19 structure, 11 process and three outcome indicators. CONCLUSION: To our knowledge this is the first quality indicator set developed for rehabilitation of rheumatic and musculoskeletal diseases. Good overall face validity and a feasible format indicate a set suitable for monitoring quality in rehabilitation. The variation in pass rates between centers indicates a potential for quality improvement in rheumatic and musculoskeletal rehabilitation in Norway.
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Enfermedades Musculoesqueléticas/rehabilitación , Mejoramiento de la Calidad/organización & administración , Indicadores de Calidad de la Atención de Salud/normas , Enfermedades Reumáticas/rehabilitación , Consenso , Estudios de Factibilidad , Humanos , Proyectos Piloto , Reproducibilidad de los ResultadosRESUMEN
OBJECTIVE: To assess the effects of robot-assisted locomotor training in patients with chronic incomplete spinal cord injury. DESIGN: Randomized single-blind controlled clinical trial. SETTING: The intervention site was an outpatient clinic, and pre- and post-evaluations were performed in a rehabilitation hospital. PATIENTS: A total of 24 subjects with American Spinal Injury Association Impairment Scale grades C or D, >?2 years post-injury. INTERVENTIONS: Subjects were randomized to 60 days of robot-assisted locomotor training, or to usual care. METHODS: Walking function, lower extremity muscle strength and balance were assessed single-blinded pre- and post-intervention. RESULTS: After a 9-year recruitment period, only 24 of the planned 30 subjects had been enrolled (mean time since injury 17 (standard deviation (SD) 20) years for all subjects). Walking function, lower extremity muscle strength and balance improved modestly in both groups, with no statistically significant group difference in walking function or muscle strength, whereas postural control declined significantly in the intervention group, compared with controls (p?=?0.03). CONCLUSION: Late-onset robot-assisted locomotor training did not re-establish independent walking function. A modest, but non-significant, effect was seen on muscle strength and balance. However, significant between-group differences were found only in postural control in the control group.
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Marcha/fisiología , Robótica/métodos , Traumatismos de la Médula Espinal/rehabilitación , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Traumatismos de la Médula Espinal/patología , Caminata/fisiología , Adulto JovenRESUMEN
OBJECTIVE: To assess the effects of manually assisted body-weight supported locomotor training in subjects with chronic incomplete spinal cord injury. DESIGN: Randomized controlled clinical trial. SUBJECTS: Twenty subjects with American Spinal Injury Association Impairment Scale grades C or D and > 2 years post-injury. METHODS: Random allocation to 60 days of body-weight supported locomotor training, or usual care, which might include over-ground walking. Walking function, lower extremity muscle strength and balance were blindly evaluated pre-/post-intervention. RESULTS: A small, non-significant improvement in walking function was observed (0.1 m/s (95% confidence interval (95% CI) -0.2, 0.4)), but subjects without baseline gait function, did not re-establish walking. The effect on lower extremity muscle strength was 2.7 points (95% CI -1.4, 6.8). No difference was observed in balance measures. CONCLUSION: Subjects with chronic incomplete spinal cord injury without baseline walking function were unable to re-establish gait with manually assisted body-weight supported locomotor training. A modest, non-significant, improvement was found in strength and walking speed. However, due to study recruitment problems, an effect size that was smaller than anticipated, and large functional heterogeneity among study subjects, the effect of late-onset body-weight supported locomotor training is not clear. Future studies should include larger numbers of subjects with less functional loss and greater functional homogeneity. Intensive training should probably start earlier post-injury.
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Terapia por Ejercicio/métodos , Marcha/fisiología , Traumatismos de la Médula Espinal/complicaciones , Caminata/fisiología , Peso Corporal , Femenino , Humanos , Masculino , Persona de Mediana Edad , Modalidades de FisioterapiaRESUMEN
OBJECTIVE: To explore changes in pain, spasticity, range of motion, activities of daily living, bowel and lower urinary tract function and quality of life of individuals with spinal cord injury following robotic exoskeleton gait training. DESIGN: Prospective, observational, open-label multicentre study. METHODS: Three training sessions per week for 8 weeks using an Ekso™ GT robotic exoskeleton (EKSO Bionics). Included were individuals with recent (<1 year) or chronic (>1 year) injury, paraplegia and tetraplegia, complete and incomplete injury, men and women. RESULTS: Fifty-two participants completed the training protocol. Pain was reported by 52% of participants during the week prior to training and 17% during training, but no change occurred longitudinally. Spasticity decreased after a training session compared with before the training session (p <0.001), but not longitudinally. Chronically injured participants increased Spinal Cord Independence Measure (SCIM III) from 73 to 74 (p = 0.008) and improved life satisfaction (p = 0.036) over 8 weeks of training. Recently injured participants increased SCIM III from 62 to 70 (p < 0.001), but no significant change occurred in life satisfaction. Range of motion, bowel and lower urinary function did not change over time. CONCLUSION: Training seemed not to provoke new pain. Spasticity decreased after a single training session. SCIM III and quality of life increased longitudinally for subsets of participants.
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Terapia por Ejercicio/métodos , Dispositivo Exoesqueleto/estadística & datos numéricos , Marcha/fisiología , Calidad de Vida/psicología , Traumatismos de la Médula Espinal/rehabilitación , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto JovenRESUMEN
Pressure is an essential parameter for the normal function of almost all organs in the human body. Measurement of pressure is therefore highly important in clinical practice and medical research. In clinical practice, pressures are often measured indirectly through a fluid line where the pressure is transmitted from the organ of interest to a remote, externally localized transducer. This method has several limitations and is prone to artefacts from movements. Results from an in vitro bench study comparing the characteristics of two different sensor systems for bladder assessment are presented; a new cystometry system using a MEMS-based in-target organ sensor was compared with a conventional system using water-filled lines connected to external transducers. Robustness to measurement errors due to patient movement was investigated through response to forced vibrations. While the new cystometry system detected real changes in applied pressure for excitation frequencies ranging from 5 Hz to 25 Hz, such small and high-frequency stimuli were not transmitted through the water-filled line connected to the external transducer. The new sensor system worked well after a resilient test at frequencies up to 70 Hz. The in-target organ sensor system will offer new possibilities for long-term monitoring of in vivo pressure in general. This opens up the possibility for future personalized medical treatment and renders possible new health services and, thereby, an increased patient empowerment and quality of life.
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Presión , Transductores de Presión , Vejiga Urinaria/fisiología , Artefactos , Humanos , Masculino , Sistemas Microelectromecánicos , Calidad de Vida , Transductores de Presión/normasRESUMEN
STUDY DESIGN: Prospective quasi-experimental study, pre- and post-design. OBJECTIVES: Assess safety, feasibility, training characteristics and changes in gait function for persons with spinal cord injury (SCI) using the robotic exoskeletons from Ekso Bionics. SETTING: Nine European rehabilitation centres. METHODS: Robotic exoskeleton gait training, three times weekly over 8 weeks. Time upright, time walking and steps in the device (training characteristics) were recorded longitudinally. Gait and neurological function were measured by 10 Metre Walk Test (10 MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS). RESULTS: Fifty-two participants completed the training protocol. Median age: 35.8 years (IQR 27.5-52.5), men/women: N = 36/16, neurological level of injury: C1-L2 and severity: AIS A-D (American Spinal Injury Association Impairment Scale). Time since injury (TSI) < 1 year, N = 25; > 1 year, N = 27. No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Training characteristics increased significantly for all subgroups. The number of participants with TSI < 1 year and gait function increased from 20 to 56% (P = 0.004) and 10MWT, TUG, BBS and LEMS results improved (P < 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05). CONCLUSIONS: Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.
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Biónica/métodos , Terapia por Ejercicio/métodos , Dispositivo Exoesqueleto , Marcha/fisiología , Traumatismos de la Médula Espinal/rehabilitación , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Traumatismos de la Médula Espinal/fisiopatología , Resultado del Tratamiento , Adulto JovenRESUMEN
An in vivo sensor system for direct measurement of pressure in the human urinary bladder is developed. The core component in the system is a small-sized and highly sensitive piezoresistive MEMS pressure sensor element integrated in a sensor catheter. The sensor catheter is wired to an external module for biasing, sampling, conversion and storage of sensor measurements. Our solution provides a target sensor placed directly into the urinary bladder and a reference sensor placed outside the bladder wall through a suprapubic and minimally invasive technique. Physiological recordings through natural filling and emptying cycles of the bladder are achievable. The case report from the first 17-hours investigation in a patient is presented in this paper. It reveals that the procedure was successful and no complications occurred. The patient expressed good experience during the participation. A functionality test shows that the percutaneous pressure sensor system responds immediately to external pressure stimuli.
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Sistemas Microelectromecánicos , Humanos , Presión , Vejiga UrinariaRESUMEN
STUDY DESIGN: Retrospective case series. INTRODUCTION: Traumatic lumbosacral dissociation (TLSD) is a rare subgroup of sacral fractures caused by high-energy trauma in healthy adults. There are no accepted treatment algorithms for these injuries. Neurologic deficits and pain are commonly associated with these injuries, however, little is known about the long-term functional outcome in patients with TLSD. The objective of this study was to assess long-term functional outcome in patients with traumatic lumbosacral dissociation (TLSD) injuries. MATERIALS AND METHODS: Thirteen patients with TLSD were retrospectively identified and followed with clinical and radiological examination mean 7.7 (3-12) years after the injury. Five were treated operatively, and eight non-operatively. Sensorimotor impairments in the lower extremities were classified according to ASIA. Urinary function was assessed with uroflowmetry, and bowel- and sexual functions were assessed using a structured interview. Pain was assessed using a visual analogue scale (VAS), and patient-reported health with SF-36. CT images were scrutinized for non-union and kyphotic angulation across the fracture. RESULTS: Eleven patients had neurologic deficits corresponding to L5 and sacral roots. Urinary dysfunction was observed in nine, and bowel dysfunction in three patients. Eight patients reported problems associated with sexual activities, with pain during intercourse and erectile dysfunction being the most common problems. Twelve patients reported pain in the lumbosacral area, in combination with radiating pain in the majority. The overall patient-reported health (SF-36) was significantly lower than the normal population. All sacral fractures were united as seen on CT. Sacral kyphotic angulation was present in 11, which had increased in three patients comparing with the initial radiographs. CONCLUSION: In this long-term follow-up, functional impairments, pain, and poor patient-reported health were common findings among patients with TLSD. High rates of neurologic, urinary and sexual dysfunctions were reported. Extended follow-up several years after the injury with a special focus on urogenital dysfunctions and pain management may be beneficial to these patients.
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Fijación Interna de Fracturas , Fracturas Óseas/fisiopatología , Región Lumbosacra/fisiopatología , Dolor Postoperatorio/rehabilitación , Complicaciones Posoperatorias/fisiopatología , Adulto , Femenino , Estudios de Seguimiento , Fijación Interna de Fracturas/efectos adversos , Curación de Fractura , Fracturas Óseas/diagnóstico por imagen , Fracturas Óseas/cirugía , Humanos , Dolor de la Región Lumbar/diagnóstico por imagen , Dolor de la Región Lumbar/etiología , Dolor de la Región Lumbar/rehabilitación , Región Lumbosacra/diagnóstico por imagen , Región Lumbosacra/lesiones , Región Lumbosacra/cirugía , Masculino , Persona de Mediana Edad , Neuralgia/diagnóstico por imagen , Neuralgia/etiología , Neuralgia/rehabilitación , Noruega/epidemiología , Dolor Postoperatorio/diagnóstico por imagen , Dolor Postoperatorio/etiología , Complicaciones Posoperatorias/rehabilitación , Radiculopatía/diagnóstico por imagen , Radiculopatía/etiología , Radiculopatía/rehabilitación , Radiografía , Estudios Retrospectivos , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Fisiológicas/rehabilitación , Tomografía Computarizada por Rayos X , Resultado del Tratamiento , Enfermedades Urológicas/etiología , Enfermedades Urológicas/rehabilitación , Adulto JovenRESUMEN
OBJECTIVES: To assess long-term patient-reported health (PRH) after displaced sacral fractures, its association with clinical outcomes, and changes over time. DESIGN: Prospective, longitudinal single-cohort study. SETTING: Level I trauma center. PATIENTS/PARTICIPANTS: From 1996 to 2001, 31 consecutive patients with operatively treated displaced sacral fractures participated in a 1-year follow-up. Twenty-eight of them were available for the present long-term follow-up of mean 10.7 years (range, 8.1-13.4) postinjury. INTERVENTION: Surgical treatment with open or closed reduction and internal fixation. MAIN OUTCOME MEASURES: PRH was the main outcome, determined by the Short Form-36 (SF-36). Data were also collected on pain (using a visual analog scale), bladder function, neurologic deficits in the lower extremities, bowel function, sexual function, activities of daily living, and employment status. SF-36 scores from the present study were compared with norm-based scores for the Norwegian general population and 1-year scores. RESULTS: At the present follow-up, mean 10.7 years (range, 8.1-13.4) postinjury, SF-36 scores were significantly lower than norm-based scores for all domains except mental health. No significant changes were observed between 1-year scores and scores from the present study. Pain correlated significantly with poor scores in the domains physical functioning (P = 0.05), role physical (P = 0.01), bodily pain (P = 0.003), general health (P = 0.007), and role emotional (P = 0.006). Sexual dysfunction correlated with poor social functioning (P = 0.013) and poor role emotional (P = 0.04); and bowel dysfunction with bodily pain (P = 0.02) and poor role emotional (P = 0.03). No correlations were found between SF-36 scores and bladder dysfunction or neurologic deficits. CONCLUSIONS: Patients with displaced sacral fractures reported poor PRH, mean 10.7 years after the initial injury, with no significant improvement compared with 1-year follow-up. A significant association was found between pain and PRH. LEVEL OF EVIDENCE: Therapeutic level IV. description of levels of evidence.
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Fracturas Óseas/cirugía , Sacro/cirugía , Actividades Cotidianas , Adulto , Anciano , Femenino , Fijación Interna de Fracturas , Fracturas Óseas/complicaciones , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Evaluación del Resultado de la Atención al Paciente , Estudios Prospectivos , Recuperación de la Función , Sacro/lesiones , Autoinforme , Resultado del TratamientoRESUMEN
This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians. Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.
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Técnicas Biosensibles/instrumentación , Sistemas Microelectromecánicos/instrumentación , Prótesis e Implantes , Humanos , PresiónRESUMEN
BACKGROUND AND PURPOSE: Neurological deficits and pain are common after displaced sacral fractures. However, little is known about the association between the long-term clinical outcomes and radiological findings. We examined the long-term radiological findings and their correlations with lumbosacral pain and neurological deficits in the lower extremities after surgery for sacral fractures. METHODS: 28 consecutive patients with operatively treated displaced sacral fractures were followed for mean 11 (8-13) years. Sensorimotor impairments of the lower extremities were classified according to the American Spinal Injury Association (ASIA). Pain was assessed using a visual analog scale (VAS). All patients underwent conventional radiographic examination and CT, and the images were scrutinized for nonunion, residual displacement, narrowing of the sacral foramina, and post-foraminal encroachment of the L5 and S1 nerves. RESULTS: There was residual displacement of ≥ 10 mm in 16 of the 28 patients. 26 patients had narrowing of 1 or more neural root foramina in L5-S4. 8 patients reported having no pain, 11 had pain only in the lumbosacral area, and 9 had pain in combination with radiating leg pain. Statistically significant correlations were found between narrowing of the sacral foramina and neurological deficits in the corresponding dermatomes. Significant correlations were also found between post-foraminal encroachment of L5 nerves and both sensory and motor deficits. No correlations were found between pain and radiological findings. INTERPRETATION: Pathological radiological findings are common 11 years after operatively treated displaced sacral fractures. Sacral foraminal and L5 post-foraminal bony encroachments were common findings and correlated with neurological deficits. However, lumbosacral pain did not correlate with radiological sequelae after fracture healing.