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BACKGROUND: Currently, non- or minimally displaced distal radius fractures are treated by 3 to 5 weeks of cast immobilisation. Many patients with a distal radius fracture suffer from long-term functional restrictions, which might be related to stiffness due to cast immobilisation. Current literature indicates that 1 week of immobilisation might be safe; however, no level 1 evidence is available. This trial aims to compare 1 week of brace immobilisation with 3 weeks of cast immobilisation in patients with distal radius fractures that do not need reduction. METHODS: The aim of this trial is to evaluate the non-inferiority of 1 week of brace immobilisation in patients with non- or minimally displaced distal radius fractures. A two-armed single blinded multicentre randomised clinical trial will be conducted in three hospitals. Adult patients, between 18 and 50 years old, independent for activities of daily living, with a non- or minimally displaced distal radius fracture can be included in this study. The intervention group is treated with 1 week of brace immobilisation, and the control group with 3 weeks of cast immobilisation. Primary outcome is the patient-reported outcome measured by the Patient-Related Wrist Evaluation score (PRWE) at 6 months. Secondary outcomes are patient-reported outcome measured by the Quick Disabilities of the Arm, Shoulder and Hand score at 6 weeks and 6 months, PRWE at 6 weeks, range of motion, patient-reported pain score measured by VAS score, radiological outcome (dorsal/volar tilt, radial height, ulnar variance, presence of intra-articular step off), complications and cost-effectiveness measured by the EuroQol 5 Dimension questionnaire, Medical Consumption Questionnaire and Productivity Cost Questionnaire. DISCUSSION: This study will provide evidence on the optimal period of immobilisation in non-operatively treated displaced and reduced distal radius fractures. Both treatment options are accepted treatment protocols and both treatment options have a low risk of complications. Follow-up will be according to the current treatment protocol. This study will provide level 1 evidence on the optimal period and way of immobilisation for non- or minimally displaced distal radius fractures in adult patients. TRIAL REGISTRATION: ABR 81638 | NL81638.029.22 | www.toetsingonline.nl . 18th of October 2023.
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Fijación de Fractura , Fracturas del Radio , Fracturas de la Muñeca , Adolescente , Adulto , Humanos , Persona de Mediana Edad , Adulto Joven , Tirantes , Moldes Quirúrgicos , Análisis Costo-Beneficio , Estudios de Equivalencia como Asunto , Fijación de Fractura/métodos , Inmovilización/métodos , Estudios Multicéntricos como Asunto , Medición de Resultados Informados por el Paciente , Fracturas del Radio/terapia , Rango del Movimiento Articular , Recuperación de la Función , Método Simple Ciego , Factores de Tiempo , Resultado del Tratamiento , Fracturas de la Muñeca/terapia , Estudios de Evaluación como AsuntoRESUMEN
Aims: There is no level I evidence dealing with the optimal period of immobilization for patients with a displaced distal radial fracture following closed reduction. A shorter period might lead to a better functional outcome due to less stiffness and pain. The aim of this study was to investigate whether this period could be safely reduced from six to four weeks. Methods: This multicentre randomized controlled trial (RCT) included adult patients with a displaced distal radial fracture, who were randomized to be treated with immobilization in a cast for four or six weeks following closed reduction. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after follow-up at one year. Secondary outcomes were the abbreviated version of the Disability of Arm, Shoulder and Hand (QuickDASH) score after one year, the functional outcome at six weeks, 12 weeks, and six months, range of motion (ROM), the level of pain after removal of the cast, and complications. Results: A total of 100 patients (15 male, 85 female) were randomized, with 49 being treated with four weeks of immobilization in a cast. A total of 93 completed follow-up. The mean PRWE score after one year was 6.9 (SD 8.3) in the four-week group compared with 11.6 (SD 14.3) in the six-week group. However, this difference of -4.7 (95% confidence interval -9.29 to 0.14) was not clinically relevant as the minimal clinically important difference of 11.5 was not reached. There was no significant difference in the ROM, radiological outcome, level of pain, or complications. Conclusion: In adult patients with a displaced and adequately reduced distal radial fracture, immobilization in a cast for four weeks is safe, and the results are similar to those after a period of immobilization of six weeks.
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Reducción Cerrada , Fracturas del Radio , Fracturas de la Muñeca , Adulto , Femenino , Humanos , Masculino , Mano , Dolor , Fracturas del Radio/cirugía , Extremidad Superior , Reducción Cerrada/métodosRESUMEN
OBJECTIVE: To determine the yield of preoperative screening for COVID-19 with chest CT and RT-PCR in patients without COVID-19 symptoms. SUMMARY OF BACKGROUND DATA: Many centers are currently screening surgical patients for COVID-19 using either chest CT, RT-PCR or both, due to the risk for worsened surgical outcomes and nosocomial spread. The optimal design and yield of such a strategy are currently unknown. METHODS: This multicenter study included consecutive adult patients without COVID-19 symptoms who underwent preoperative screening using chest CT and RT-PCR before elective or emergency surgery under general anesthesia. RESULTS: A total of 2093 patients without COVID-19 symptoms were included in 14 participating centers; 1224 were screened by CT and RT-PCR and 869 by chest CT only. The positive yield of screening using a combination of chest CT and RT-PCR was 1.5% [95% confidence interval (CI): 0.8-2.1]. Individual yields were 0.7% (95% CI: 0.2-1.1) for chest CT and 1.1% (95% CI: 0.6-1.7) for RT-PCR; the incremental yield of chest CT was 0.4%. In relation to COVID-19 community prevalence, up to â¼6% positive RT-PCR was found for a daily hospital admission rate >1.5 per 100,000 inhabitants, and around 1.0% for lower prevalence. CONCLUSIONS: One in every 100 patients without COVID-19 symptoms tested positive for SARS-CoV-2 with RT-PCR; this yield increased in conjunction with community prevalence. The added value of chest CT was limited. Preoperative screening allowed us to take adequate precautions for SARS-CoV-2 positive patients in a surgical population, whereas negative patients needed only routine procedures.
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Infecciones Asintomáticas , COVID-19/diagnóstico , Tratamiento de Urgencia , Tamizaje Masivo/estadística & datos numéricos , Cuidados Preoperatorios/métodos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , SARS-CoV-2 , Procedimientos Quirúrgicos Operativos , Tórax/diagnóstico por imagen , Tomografía Computarizada por Rayos X , Procedimientos Quirúrgicos Electivos , Humanos , Estudios RetrospectivosRESUMEN
PURPOSE: To allow physicians to be more selective in their request for a radiograph of the wrist and to potentially reduce costs, the Amsterdam Wrist Rules (AWR) have been developed, externally validated, and recently also implemented. The aim of this study was to conduct an incremental cost analysis and budget impact analysis of the implementation of the AWR at the emergency department (ED) in the Netherlands. METHODS: A cost-minimisation analysis to determine the expected cost savings for implementation of the Amsterdam Wrist Rules. The incremental difference in costs before and after implementation of the AWR was based on the reduction in costs for radiographs, the cost savings due to reduction of ED consultation times and the costs of a re-evaluation appointment by a physician. RESULTS: In the Netherlands, implementation of the AWR could potentially result in 6% cost savings per patient with a wrist injury. In addition, implementation of the AWR resulted in 203,510 cost savings annually nationwide. In the sensitivity analysis, an increase in physician compliance to 100% substantially increased the potential total amount of annual cost savings to 610,248, which is 6% of total costs before implementation. Variation in time spent at the ED, a decrease and increase in costs and patients presenting annually at the ED did not change the cost savings substantially. CONCLUSION: Implementation of the AWR has been shown to reduce direct and indirect costs and can, therefore, result in considerable savings of healthcare consumption and expenditure.
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Mejoramiento de la Calidad/economía , Radiografía/economía , Derivación y Consulta/economía , Traumatismos de la Muñeca/diagnóstico por imagen , Traumatismos de la Muñeca/economía , Adulto , Anciano , Análisis Costo-Beneficio , Técnicas de Apoyo para la Decisión , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos , Radiografía/métodosRESUMEN
The original version of this article unfortunately contained a mistake. The spelling of the J. Carel Goslings' name was incorrect. The correct information is given above.
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PURPOSE: While most patients with wrist trauma are routinely referred for radiography, around 50% of these radiographs show no fracture. To avoid unnecessary radiographs, the Amsterdam Wrist Rules (AWR) have previously been developed and validated. The aim of the current study was to evaluate the effect of the implementation of the AWR at the Emergency Department (ED). METHODS: In a before-and-after comparative prospective cohort study, all consecutive adult patients with acute wrist trauma presenting at the ED of four hospitals were included. Primary outcome was the number of wrist radiographs before and after implementation of the AWR. Secondary outcomes were the number of clinically relevant missed fractures, the overall length of stay in the ED, physician compliance regarding the AWR, and patient satisfaction and experience with the care received at the ED. RESULTS: A total of 402 patients were included. The absolute reduction in wrist radiographs after implementation was 15% (p < 0.001). One clinically irrelevant fracture was missed. Non-fracture patients without wrist radiography due to the AWR spent 34 min less time in the ED compared with non-fracture patients who had a wrist radiograph (p = 0.015). The physicians adhered to the AWR in 36% of patients. Of all patients who did not receive a radiographic examination of the wrist, 87% were satisfied. CONCLUSION: Implementation of the AWR safely reduces the amount of wrist radiographs in selected patients and consequently reducing the length of stay in the ED.
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Técnicas de Apoyo para la Decisión , Fracturas del Radio/diagnóstico por imagen , Procedimientos Innecesarios , Traumatismos de la Muñeca/diagnóstico por imagen , Muñeca/diagnóstico por imagen , Adulto , Anciano , Servicio de Urgencia en Hospital , Femenino , Humanos , Tiempo de Internación/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios ProspectivosRESUMEN
INTRODUCTION: Up to 30% of patients with a dislocated distal radial fracture (DRF) treated with closed reduction and cast immobilisation suffer from long-term functional restrictions. It remains unclear, whether duration of cast immobilisation influences functional outcome. The aim of this study is to evaluate whether the functional outcome of dislocated DRFs could be improved by shortening the period of immobilisation. METHODS AND ANALYSIS: A single blinded multicentre randomised controlled trial is initiated. Four weeks of plaster cast immobilisation is compared with six week plaster cast immobilisation in adult patients with adequate reduced DRFs. Primary outcome parameters are functional outcome measured with the Patient Rated Wrist Evaluation after 1 year of follow-up (FU). Secondary outcomes are: Disability of Arm, Shoulder and Hand Score after 1 year, 36-Item Short Form Health Survey after 1 year, functional outcome earlier in FU (6 weeks, 12 weeks and 6 months), range of motion, pain level and complications: number of re-interventions, secondary dislocation, delayed and non-union. ETHICS AND DISSEMINATION: The medical ethical committee VUmc approved the study protocol (2018.004, NL62861.029.17). The expectation of this study is that a shorter duration of plaster cast immobilisation is beneficial. This risk of specific complications is low and generally similar in both treatment options. FU is standardised according to current trauma guidelines. Present literature indicates that both treatment options that are used within this study are accepted protocols for treatment of dislocated DRFs. This trial will provide Level-I evidence for the comparison of functional outcome between the two treatment options for dislocated DRFs. Results of this study are expected to be published as a prospective, multicentre, randomised controlled trial article in 2021. TRIAL REGISTRATION: The Netherlands National Trial Register: NTR 6600, ABR: NL62861.029.17. Medical Ethical Committee VUmc registration number: 2018.004.
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Moldes Quirúrgicos , Reducción Cerrada , Inmovilización/métodos , Luxaciones Articulares/terapia , Fracturas del Radio/terapia , Adulto , Anciano , Femenino , Humanos , Luxaciones Articulares/fisiopatología , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Fracturas del Radio/fisiopatología , Rango del Movimiento Articular/fisiología , Recuperación de la Función/fisiologíaRESUMEN
INTRODUCTION: Every year patients present to the emergency department due to bites, scratches and falls caused by animals. Although bite and scratch injuries have been described in literature, the exact number of patients that visit the emergency department due to all animal related injuries has never been described before. METHODS: A retrospective analysis of all emergency department visits throughout a 1-year period was performed from April 2015 until March 2016. RESULTS: 516 Patients were treated at the emergency department because of animal related injuries. Most were female and the median age was 38â¯years. The animals causing most injuries were horses, followed by dogs and cats. Animal related injuries more often caused fractures (nâ¯=â¯165) or contusions (nâ¯=â¯171) compared to wounds (nâ¯=â¯135). No lethal injuries were recorded. However, three animals did not survive the event. CONCLUSIONS: The incidence of animal related injuries is 2.8% and this is probably an underestimation. The injuries have noteworthy origins and have potentially severe physical injury as result. Awareness in the general population on the potential dangers of pets and horses could reduce the number and severity of animal related injuries.
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BACKGROUND: The Amsterdam Pediatric Wrist Rules have been developed and validated to reduce wrist radiographs following wrist trauma in pediatric patients. However, the actual impact should be evaluated in an implementation study. OBJECTIVE: To evaluate the effect of implementation of the Amsterdam Pediatric Wrist Rules at the emergency department. MATERIALS AND METHODS: A before-and-after comparative prospective cohort study was conducted, including all consecutive patients aged 3 to 18 years presenting at the emergency department with acute wrist trauma. The primary outcome was the difference in the number of wrist radiographs before and after implementation. Secondary outcomes were the number of clinically relevant missed fractures of the distal forearm, the difference in length of stay at the emergency department and physician compliance with the Amsterdam Pediatric Wrist Rules. RESULTS: A total of 408 patients were included. The absolute reduction in radiographs was 19% compared to before implementation (chi-square test, P<0.001). Non-fracture patients who were discharged without a wrist radiograph had a 26-min shorter stay at the emergency department compared to patients who received a wrist radiograph (68 min vs. 94 min; Mann-Whitney U test, P=0.004). Eight fractures were missed following the recommendation of the Amsterdam Pediatric Wrist Rules. However, only four of them were clinically relevant. CONCLUSION: Implementing the Amsterdam Pediatric Wrist Rules resulted in a significant reduction in wrist radiographs and time spent at the emergency department. The Amsterdam Pediatric Wrist Rules were able to correctly identify 98% of all clinically relevant distal forearm fractures.
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Toma de Decisiones Clínicas , Servicio de Urgencia en Hospital/normas , Adhesión a Directriz , Traumatismos de la Muñeca/diagnóstico por imagen , Adolescente , Niño , Preescolar , Errores Diagnósticos/estadística & datos numéricos , Femenino , Humanos , Lactante , Tiempo de Internación/estadística & datos numéricos , Masculino , Países Bajos , Estudios ProspectivosRESUMEN
Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.
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Antibacterianos/administración & dosificación , Profilaxis Antibiótica , Cefazolina/administración & dosificación , Remoción de Dispositivos/efectos adversos , Fracturas Óseas/cirugía , Extremidad Inferior/lesiones , Infección de la Herida Quirúrgica/prevención & control , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Incidencia , Infusiones Intravenosas , Análisis de Intención de Tratar , Fijadores Internos , Masculino , Persona de Mediana Edad , Prótesis e Implantes/efectos adversos , Calidad de Vida , Infección de la Herida Quirúrgica/epidemiología , Adulto JovenRESUMEN
BACKGROUND: Although only 39% of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. METHOD: This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. RESULTS: A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95% CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98% (95% CI: 95-99%) and 21% (95% CI: 15%-28). The negative predictive value was 90% (95% CI: 81-99%). CONCLUSION: The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs.
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BACKGROUND: In most hospitals, children with acute wrist trauma are routinely referred for radiography. OBJECTIVE: To develop and validate a clinical decision rule to decide whether radiography in children with wrist trauma is required. MATERIALS AND METHODS: We prospectively developed and validated a clinical decision rule in two study populations. All children who presented in the emergency department of four hospitals with pain following wrist trauma were included and evaluated for 18 clinical variables. The outcome was a wrist fracture diagnosed by plain radiography. RESULTS: Included in the study were 787 children. The prediction model consisted of six variables: age, swelling of the distal radius, visible deformation, distal radius tender to palpation, anatomical snuffbox tender to palpation, and painful or abnormal supination. The model showed an area under the receiver operator characteristics curve of 0.79 (95% CI: 0.76-0.83). The sensitivity and specificity were 95.9% and 37.3%, respectively. The use of this model would have resulted in a 22% absolute reduction of radiographic examinations. In a validation study, 7/170 fractures (4.1%, 95% CI: 1.7-8.3%) would have been missed using the decision model. CONCLUSION: The decision model may be a valuable tool to decide whether radiography in children after wrist trauma is required.
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Toma de Decisiones Clínicas , Pediatría/normas , Guías de Práctica Clínica como Asunto , Radiografía/normas , Fracturas del Radio/diagnóstico por imagen , Traumatismos de la Muñeca/diagnóstico por imagen , Enfermedad Aguda , Algoritmos , Niño , Preescolar , Técnicas de Apoyo para la Decisión , Femenino , Humanos , Lactante , Recién Nacido , Masculino , Países Bajos , Interpretación de Imagen Radiográfica Asistida por Computador/normas , Reproducibilidad de los Resultados , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Although only 39 % of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. METHODS: This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. RESULTS: A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95 % CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98 % (95 % CI: 95-99 %) and 21 % (95 % CI: 15 %-28). The negative predictive value was 90 % (95 % CI: 81-99 %). CONCLUSIONS: The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs. TRIAL REGISTRATION: This study was registered in the Dutch Trial Registry, reference number NTR2544 on October 1(st), 2010.
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Toma de Decisiones Clínicas , Servicio de Urgencia en Hospital/normas , Traumatismos de la Muñeca/diagnóstico por imagen , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Persona de Mediana Edad , Países Bajos/epidemiología , Estudios Prospectivos , Radiografía/normas , Radiografía/estadística & datos numéricos , Traumatismos de la Muñeca/epidemiologíaRESUMEN
BACKGROUND: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. METHODS: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). DISCUSSION: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of 3.5 million per year. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.