Evaluation of Safety and Efficacy of ReHub in Patients Who Underwent Primary Total Knee Arthroplasty: Study Protocol for a Randomized Controlled Trial.

BACKGROUND: Total Knee Arthroplasty (TKA) is an intervention that can significantly improve the quality of life of patients with advanced knee osteoarthritis. Early start of rehabilitation and its continuation at home once the patient is discharged are key factors for the success of the process.This study aims to assess the effectiveness of a home-based telerehabilitation solution (ReHub) on improving functional capacity and clinical outcomes for patients who underwent TKA. METHODS/DESIGN: The study is a randomized, open-label with blinded outcome assessor, parallel assignment clinical trial with a sample size of 52 patients that is conducted according to the SPIRIT recommendations. After the TKA intervention, the patients are randomly allocated to the control group or the experimental group with a 1:1 ratio. Both groups follow a Fast Track recovery protocol which includes discharge after 2-3 days from surgery, a daily plan of 5 exercises for autonomous rehabilitation and domiciliary visits by a physiotherapist starting approximately 2 weeks after surgery. The experimental group uses the sensor-based telerehabilitation system ReHub to perform the exercises. The primary outcome measure is the range of motion of the knee. Secondary outcomes include physical performance, quality of life, pain intensity, muscle strength, treatment adherence and satisfaction with the ReHub system. The outcomes assessment is performed at hospital discharge (baseline), at stitch removal (2 weeks after baseline) and 2 weeks after stitch removal (4 weeks after baseline).The study conforms to the guidelines of the Declaration of Helsinki and was approved by the hospital's ethics committee. DISCUSSION: The study will address an important gap in the evidence base by reporting the effectiveness of an affordable and low-cost home-based telerehabilitation solution in patients who underwent TKA. ETHICS AND DISSEMINATION: The study was approved by the hospital's ethics committee ("Comité Ético de Investigación Clínica del HCB", reg. HCB/2019/0571). The trial was registred at ClinicalTrials.gov (NCT04155957). The results of this study will be published in peer-reviewed journals as well as national and international conferences. TRIAL REGISTRATION: NCT04155957 (ClinicalTrials.gov). HIGHLIGHTS: Assessing a home-based telerehabilitation solution effectiveness in knee surgery.In situations such as the CoVid-19 pandemic, it is a resolutive intervention method.Telerehabilitation is an alternative to conventional face-to-face physical therapy.This system is far less demanding in terms of human resources.Range of motion assessment is the primary outcome measure.

Internal fixation of proximal humerus fractures using the T2-proximal humeral nail.

INTRODUCTION: Surgical management of proximal humerus fractures remains controversial and there is an increasing interest in intramedullary nailing. Created to improve previous designs, the T2-proximal humeral nail (PHN) (Stryker) has been recently released, and the English literature lacks a series evaluating its results. We present a clinical prospective study evaluating this implant for proximal humeral fractures. METHOD: We evaluated the functional and radiological results and possible complications. Twenty-nine patients with displaced fractures of the proximal humerus were treated with this nail. One patient was lost right after surgery and excluded from the assessment. Eighteen patients were older than 70 years. RESULTS: There were 21 fractures of the proximal part of the humerus and 7 fractures that also involved the shaft; 15 of the fractures were two-part fractures (surgical neck), 5 were three-part fractures, and 1 was a four-part fracture. All fractures healed in a mean period of 2.7 months. There was one delayed union that healed in 4 months. One case of avascular necrosis of the humeral head was observed (a four-part fracture), but remained asymptomatic and did not require further treatment. In one case a back-out of one proximal screw was observed. A final evaluation with a minimum 1 year follow-up was performed by an independent observer; in 18 patients, the mean Constant score was 65.7 or 76.1% with the adjustment of age and gender; in 19 patients, the mean Oxford Shoulder Score was 21.7. The results obtained with the T2-PHN nail indicate that it represents a safe and reliable method in the treatment of two- and three-part fractures of the proximal humerus. The proximal fixation mechanism diminishes the rate of back-out of the screws, a frequent complication described in the literature. Better functional results were obtained from the patients younger than 70 years, but these were not statistically significant.

Clinical translation of a mesenchymal stromal cell-based therapy developed in a large animal model and two case studies of the treatment of atrophic pseudoarthrosis.

Pseudoarthrosis is a relatively frequent complication of fractures, in which the lack of mechanical stability and biological stimuli results in the failure of bone union, most frequently in humerus and tibia. Treatment of recalcitrant pseudoarthrosis relies on the achievement of satisfactory mechanical stability combined with adequate local biology. Herein we present two cases of atrophic pseudoarthrosis that received a tissue-engineering product (TEP) composed of autologous bone marrow-derived mesenchymal stromal cells (BM-MSC) combined with deantigenized trabecular bone particles from a tissue bank. The feasibility of the treatment and osteogenic potential of the cell-based medicine was first demonstrated in an ovine model of critical size segmental tibial defect. Clinical-grade autologous BM-MSC were produced following a good manufacturing practice-compliant bioprocess. Results were successful in one case, with pseudoarthrosis resolution, and inconclusive in the other one. The first patient presented atrophic pseudoarthrosis of the humeral diaphysis and was treated with osteosynthesis and TEP resulting in satisfactory consolidation at month 6. The second case presented a recalcitrant pseudoarthrosis of the proximal tibia and the Masquelet technique was followed before filling the defect with the TEP. This patient presented a neuropathic pain syndrome unrelated to the treatment that forced the amputation of the extremity 3 months later. In this case, the histological analysis of the tissue formed at the defect site provided evidence of neovascularization but no overt bone remodelling activity. It is concluded that the use of expanded autologous BM-MSC to treat pseudoarthrosis was demonstrated to be feasible and safe, provided that no clinical complications were reported, and early signs of effectiveness were observed. Copyright © 2016 John Wiley & Sons, Ltd.

[Process indicators: tools for monitoring the management of severe trauma cases in Catalonia]. / Indicadores de proceso como herramienta para monitorizar la asistencia al paciente con traumatismo grave en Cataluña.

OBJECTIVES: Process indicators have been widely used to monitor the way trauma care is provided. We aimed to analyze whether data from a hospital's severe trauma register could facilitate the evaluation of aspects of the initial management of severe injuries. MATERIAL AND METHODS: Observational, retrospective population-based study. A working group of experts selected a set of trauma care process indicators relevant to some aspects of initial care, diagnosis, and treatment of severely injured patients. Four of the indicators referred to prehospital care and 5 to hospital care. We calculated the observed and expected compliance rates for all the indicators. RESULTS: A total of 1526 cases (44.4%) were analyzed for 2013; 1908 (55.6%) were analyzed for 2014. We were able to evaluate 3 of the 4 prehospital process indicators: endotracheal intubation in patients with a score of 􀀀 8 on the Glasgow coma scale (GCS) (84% compliance), venous access established before hospital arrival (83.4%), and placement of a neck collar to immobilize the cervical spine (72.7%). Compliance for the hospital-phase indicators were as follows: performance of a computed tomography scan of the head within 60 minutes in cases with a GCS of 􀀀 13 (5.3% compliance, craniotomy in candidate patients within 2 hours of diagnosis (65%), diagnostic examination for abdominal injuries within 60 minutes in patients with systolic blood pressure 􀀀 90 mm Hg (89.3%), and therapeutic laparotomy or angiography within 4 hours of abdominal injury in candidate patients with systolic blood pressure 􀀀 90 mm Hg (51.7%). Compliance was 69.9% for the last process indicator: surgical treatment of open fractures within 8 hours of an accident. CONCLUSION: Our findings show that a hospital trauma register provides data about care process indicators that can allow us to monitor the quality of care of severely injured patients.

OBJETIVO: Los indicadores de proceso (IP) se han utilizado ampliamente para monitorizar los procesos asistenciales al paciente traumático. Nuestro objetivo es analizar la capacidad de un registro hospitalario de traumatismo grave para evaluar algunos aspectos de la atención inicial al traumatismo grave. METODO: Observacional, retrospectivo de datos incluidos en un registro poblacional. A partir de un consenso de expertos se seleccionaron una serie de IP que se aplicaron a una población de accidentados. Los IP seleccionados analizan algunos aspectos de la atención inicial, diagnósticos y terapéuticos. Cuatro de ellos se refieren a la fase prehospitalaria y 5 a la fase hospitalaria. Para todos ellos se calculó la tasa de cumplimiento (observados vs esperados). RESULTADOS: Fueron analizados 1.526 casos (44,4%) correspondientes al año 2013 y 1.908 (55,6%) del 2014. Tres de los cuatro IP relacionados con la atención prehospitalaria pudieron ser analizados: intubación orotraqueal en paciente con puntuación de la Escala del Coma de Glasgow (GCS) 8 (84% de cumplimiento); acceso vascular canalizado antes de la llegada al hospital (83,4% de cumplimiento); y contención cervical aplicada in situ (72,7% de cumplimiento). En la fase hospitalaria: realización de tomografía computarizada (TC) craneal en los primeros 60 min en GCS ô€€€ 13 (5,3% de cumplimiento); craneotomía en paciente candidato en las primeras 2 horas después del diagnóstico (65% de cumplimiento); exploración diagnóstica en traumatismo abdominal en los primeros 60 minutos en pacientes con presión arterial sistólica (PAS) 90 mmHg (89,3% de cumplimiento); y laparotomía o angiografía terapéutica en paciente candidato en las 4 primeras horas tras el trauma abdominal y PAS 90 (51,7% de cumplimiento). El último indicador, cirugía de fractura abierta en las primeras 8 horas tras el accidente, presentó un 69,9% de cumplimiento. CONCLUSIONES: Nuestro estudio muestra las posibilidades y dificultades que un registro de traumatismo en base hospitalaria ofrece para evaluar la asistencia al paciente traumático a través de indicadores de proceso establecidos.

[Study on the improvement of trauma patient care: TRAUMACAT project]. / Estudio para la mejoría de la atención hospitalaria inicial del paciente politraumatizado: proyecto TRAUMACAT.

UNLABELLED: Multiple injuries are a major source of morbidity and mortality in young people. The aim of this study was to evaluate the effect of a collaborative strategy to improve the implementation of six clinical indicators, recognized internationally, for the treatment of trauma patient. Prospective, multicentre, pre-and post-intervention study, in ten referral hospitals, offering polytrauma care in Catalonia. 378 patients were recruited for the pre-intervention study and 501 for the post-intervention study. All patients had a history of high-energy trauma requiring admission to critical or semi-critical care unit. INTERVENTION: collaborative strategy aimed at participating professionals, involving the creation of a panel of experts, appointment of monitors to encourage improvements at each centre, training, distribution of information, material and meetings, to exchange impressions. MAIN OUTCOME MEASURES: frequency and characteristics of trauma and percentage of compliance with clinical indicators. Study of 879 trauma patients. The injury mechanism was overall blunt trauma, in both pre and post intervention phases. The medium ISS (injury severity score) was 21 ± 12,8 and the medium TRISS (trauma and injury severity score) was 26,4 ± 11,4. We didn't find differences between both study phases, in relation to the severity of injury. The mortality rate was 11.5%. We observed significant improvement in the performance of chest X-rays (45% vs. 62%) and pelvis X-rays (27% vs. 62%) in the trauma box and in the fixation of the pelvis in patients with a fracture at this site (24% vs. 49%). The use of diagnostic radiology in hemodynamically unstable patients remained low (33%). The collaborative strategy was effective in improving certain indicators of clinical management.

Indicadores de proceso como herramienta para monitorizar la asistencia al paciente con traumatismo grave en Cataluña / Process indicators: tools for monitoring the management of severe trauma cases in Catalonia

Objetivos: Los indicadores de proceso (IP) se han utilizado ampliamente para monitorizar los procesos asistenciales al paciente traumático. Nuestro objetivo es analizar la capacidad de un registro hospitalario de traumatismo grave para evaluar algunos aspectos de la atención inicial al traumatismo grave. Método: Observacional, retrospectivo de datos incluidos en un registro poblacional. A partir de un consenso de expertos se seleccionaron una serie de IP que se aplicaron a una población de accidentados. Los IP seleccionados analizan algunos aspectos de la atención inicial, diagnósticos y terapéuticos. Cuatro de ellos se refieren a la fase prehospitalaria y 5 a la fase hospitalaria. Para todos ellos se calculó la tasa de cumplimiento (observados vs esperados). Resultados: Fueron analizados 1.526 casos (44,4%) correspondientes al año 2013 y 1.908 (55,6%) del 2014. Tres de los cuatro IP relacionados con la atención prehospitalaria pudieron ser analizados: intubación orotraqueal en paciente con puntuación de la Escala del Coma de Glasgow (GCS) mas o igual a 8 (84% de cumplimiento); acceso vascular canalizado antes de la llegada al hospital (83,4% de cumplimiento); y contención cervical aplicada in situ (72,7% de cumplimiento). En la fase hospitalaria: realización de tomografía computarizada (TC) craneal en los primeros 60 min en GCS menor o igual a 13 (5,3% de cumplimiento); craneotomía en paciente candidato en las primeras 2 horas después del diagnóstico (65% de cumplimiento); exploración diagnóstica en traumatismo abdominal en los primeros 60 minutos en pacientes con presión arterial sistólica (PAS) menor o igual a 90 mmHg (89,3% de cumplimiento); y laparotomía o angiografía terapéutica en paciente candidato en las 4 primeras horas tras el trauma abdominal y PAS menor o igual a 90 (51,7% de cumplimiento). El último indicador, cirugía de fractura abierta en las primeras 8 horas tras el accidente, presentó un 69,9% de cumplimiento. Conclusiones: Nuestro estudio muestra las posibilidades y dificultades que un registro de traumatismo en base hospitalaria ofrece para evaluar la asistencia al paciente traumático a través de indicadores de proceso establecidos (AU)

Background and objectives: Process indicators have been widely used to monitor the way trauma care is provided. We aimed to analyze whether data from a hospital’s severe trauma register could facilitate the evaluation of aspects of the initial management of severe injuries. Methods: Observational, retrospective population-based study. A working group of experts selected a set of trauma care process indicators relevant to some aspects of initial care, diagnosis, and treatment of severely injured patients. Four of the indicators referred to prehospital care and 5 to hospital care. We calculated the observed and expected compliance rates for all the indicators. Results: A total of 1526 cases (44.4%) were analyzed for 2013; 1908 (55.6%) were analyzed for 2014. We were able to evaluate 3 of the 4 prehospital process indicators: endotracheal intubation in patients with a score of less than or equal to to 8 on the Glasgow coma scale (GCS) (84% compliance), venous access established before hospital arrival (83.4%), and placement of a neck collar to immobilize the cervical spine (72.7%). Compliance for the hospital-phase indicators were as follows: performance of a computed tomography scan of the head within 60 minutes in cases with a GCS of less than or equal to 13 (5.3% compliance, craniotomy in candidate patients within 2 hours of diagnosis (65%), diagnostic examination for abdominal injuries within 60 minutes in patients with systolic blood pressure less than or equal to 90 mm Hg (89.3%), and therapeutic laparotomy or angiography within 4 hours of abdominal injury in candidate patients with systolic blood pressure less than or equal to 90 mm Hg (51.7%). Compliance was 69.9% for the last process indicator: surgical treatment of open fractures within 8 hours of an accident. Conclusion: Our findings show that a hospital trauma register provides data about care process indicators that can allow us to monitor the quality of care of severely injured patients (AU)

Less invasive fixation of an interthrocanteric fracture in an ankylosed hip with cannulated screws: a case report.

A 68-year-old woman presented following a road accident with an undisplaced intertrochanteric fracture affecting an ankylosed hip and an ipsilateral calcaneal fracture. The interthrocanteric fracture was fixed with four 7.0 mm cannulated screws. The calcaneal fracture was fixed with K wires and immobilized in a plaster. Because of this combination of injuries, although she was allowed to mobilize non weight bearing from the first week, sitting and progressive weight bearing were not permitted for six weeks. Radiographs taken at the one year showed consolidation of the hip fracture without complications. Final functional indices showed an EQ-5D VAS score of 40, EQ-5D health state index adapted to Spanish value sets of 0.493 and an Oxford Hip Score of 31. Screw fixation of an undisplaced intertrochanteric fracture in an ankylosed hip may be sufficient in some instances provided the patient remains non weight bearing for long enough.

Cortical strut allograft as an adjunct to plate fixation for periprosthetic fractures of the femur.

The use of cortical strut allografts in the treatment of periprosthetic femoral fractures remain controversial. Complications such as infection and the potential transmission of disease remain concerns. A retrospective review at a tertiary-care hospital was completed of 21 patients who had sustained a periprosthetic femoral fracture and who were treated using a plate and a deep-frozen cortical strut allograft, between 1996 and 2007. The average age at the time of surgery was 80.3 years old and included 16 women and 5 men. Three patients were lost to follow-up and four died within a few weeks of discharge. The remaining 14 patients were evaluated clinically and radiographically with a mean follow-up of 3.2 years. Fracture union was observed in 13 patients, and integration of the graft occurred in 12 patients. One of the 14 patients developed a deep infection with Coagulase-Negative Staphylococcus, with a satisfactory outcome after surgical debridement and antibiotic treatment. There were no cases of fixation failure or plate rupture. At the final evaluation, the mean EQ-5D VAS score was 64 (ranging from 40-90 points) and the mean EQ-5D health state index adapted to Spanish value sets was 0.57. The mean Oxford Hip Score was 31.2. The results support the use of cortical allograft for these fractures to increase the likelihood of fracture healing and to improve the bone stock. We consider that cortical strut grafting is specially indicated for B1 and C fractures in which decreased bone density is present.

Estudio para la mejoría de la atención hospitalaria inicial del paciente politraumatizado: proyecto TRAUMACAT / Study on the improvement of trauma patient care: TRAUMACAT project

Los politraumatismos constituyen una importante causa de morbimortalidad en la población joven. El objetivo del estudio fue recoger y analizar el efecto de una estrategia de carácter colaborativo para mejorar la aplicación de 6 indicadores clínicos reconocidos a nivel internacional como imprescindibles en el correcto tratamiento de los pacientes politraumatizados. Estudio prospectivo multicéntrico pre y postintervención en 10 hospitales de referencia en la atención de pacientes politraumatizados de Catalunya. Se reclutaron respectivamente 378 y 501 pacientes en el período pre y postintervención. Para ser incluidos debían tener antecedentes de un traumatismo de alta energía, siendo preciso su ingreso en una unidad de críticos o semicríticos. Intervención: estrategia colaborativa dirigida a profesionales de los hospitales participantes, que incluyó la constitución de un grupo de expertos, asignación de responsables para incentivar mejoras en cada centro, formación, distribución de material informativo y reuniones para intercambio de experiencias. Principales medidas de resultado: frecuencia y características del politraumatismo y porcentaje en el cumplimiento de indicadores clínicos. Análisis de 879 pacientes politraumatizados. Los mecanismos de lesión fueron mayoritariamente causados por trauma cerrado en ambas fases del estudio. El ISS (injury severity score) medio global de toda la muestra fue de 21 ± 12,8 y el TRISS (trauma and injury severity score) medio global de la serie del 26,4 ± 11,4. No hubo diferencias en cuanto a la gravedad entre los 2 períodos del estudio. La mortalidad global de la muestra fue del 11,5%. En cuanto a los indicadores clínicos, se identificaron mejoras significativas en los períodos pre y postintervención en la realización de radiografías de tórax (el 45 frente al 62%) y de pelvis (el 27 frente al 62%) en cubículo de trauma y en la fijación de la pelvis en pacientes con fractura a este nivel (el 24 frente al 49%). En el traslado de pacientes hemodinámicamente inestables a radiología diagnóstica no se observaron cambios, manteniéndose valores de cumplimiento bajos (33%). La estrategia colaborativa ha sido efectiva para mejorar algunos indicadores de manejo clínico (AU)

Multiple injuries are a major source of morbidity and mortality in young people. The aim of this study was to evaluate the effect of a collaborative strategy to improve the implementation of six clinical indicators, recognized internationally, for the treatment of trauma patient. Prospective, multicentre, pre-and post-intervention study, in ten referral hospitals, offering polytrauma care in Catalonia. 378 patients were recruited for the pre-intervention study and 501 for the post-intervention study. All patients had a history of high-energy trauma requiring admission to critical or semi-critical care unit. Intervention: collaborative strategy aimed at participating professionals, involving the creation of a panel of experts, appointment of monitors to encourage improvements at each centre, training, distribution of information, material and meetings, to exchange impressions. Main outcome measures: frequency and characteristics of trauma and percentage of compliance with clinical indicators. Study of 879 trauma patients. The injury mechanism was overall blunt trauma, in both pre and post intervention phases. The medium ISS (injury severity score) was 21 ± 12,8 and the medium TRISS (trauma and injury severity score) was 26,4 ± 11,4. We didn't find differences between both study phases, in relation to the severity of injury. The mortality rate was 11.5%. We observed significant improvement in the performance of chest X-rays (45% vs. 62%) and pelvis X-rays (27% vs. 62%) in the trauma box and in the fixation of the pelvis in patients with a fracture at this site (24% vs. 49%). The use of diagnostic radiology in hemodynamically unstable patients remained low (33%). The collaborative strategy was effective in improving certain indicators of clinical management (AU)

Tuberculosis espinal: tratamiento quirúrgico temprano coadyuvante al tratamiento médico / Spinal tuberculosis: early surgical treatment combined with medical treatment

FUNDAMENTO: La tuberculosis vertebral puede producir cifosis con déficit neurológico a pesar del tratamiento antibiótico. En ausencia de respuesta a la medicación debe efectuarse curetaje del foco, desbridamiento y fusión. Las características biológicas de Mycobacterium tuberculosis no impiden la osteosíntesis sobre el hueso infectado. PACIENTES Y MÉTODO: Cinco pacientes con tuberculosis vertebral y déficit neurológico fueron tratados mediante curetaje, desbridamiento, fusión intersomática y osteosíntesis anterior además del tratamiento médico. En tres pacientes se añadió fusión posterior para asegurar la estabilidad de la osteosíntesis. Todos presentaban astenia y paresia de extremidades inferiores, dos pacientes sufrían una radiculopatía de L4 y otro paciente presentó una paraparesia. El valor medio de la cifosis vertebral fue de 22,8°. El seguimiento ha sido de 3,1 años, y se descartó a un paciente por seguimiento insuficiente. RESULTADOS: No se ha producido ningún aflojamiento séptico del material de osteosíntesis ni progresión de la enfermedad. La corrección de la cifosis ha sido del 104,5 por ciento postoperatoria y del 80,5 por ciento al final del seguimiento. Se ha recuperado el déficit neurológico en todos los pacientes, excepto en uno con dolor metamérico L4. CONCLUSIONES: La instrumentación anterior permite la descompresión espinal, la limpieza del foco séptico, la corrección de la deformidad y el aporte de hueso autólogo. En aplastamientos cifóticos graves es aconsejable asociar una artrodesis posterior economizando el número de niveles. La asociación de los tratamientos médico y quirúrgico mejora la evolución de los pacientes cuando aparecen fracturas patológicas o en ausencia de respuesta al tratamiento antibiótico (AU)