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1.
PLoS One ; 18(12): e0294290, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38064443

RESUMO

Managing tibial fractures requires substantial health resources, which costs the health system. This study aimed to describe the costs of photobiomodulation (PBM) with LEDs in the healing process of soft tissue lesions associated with tibial fracture compared to a placebo. Economic analysis was performed based on a randomized controlled clinical trial, with a simulation of the cost-effectiveness and incremental cost model. Adults (n = 27) hospitalized with tibia fracture awaiting definitive surgery were randomized into two distinct groups: the PBM Group (n = 13) and the Control Group with simulated phototherapy (n = 14). To simulate the cost-effectiveness and incremental cost model, the outcome was the evolution of wound resolution by the BATES-JENSEN scale and time of wound resolution in days. The total cost of treatment for the Control group was R$21,164.56, and a difference of R$7,527.10 more was observed when compared to the treatment of the PBM group. The proposed intervention did not present incremental cost since the difference in the costs to reduce measures between the groups was smaller for the PBM group. When analyzing the ICER (Incremental cost-effectiveness ratio), it would be possible to save R$3,500.98 with PBM and decrease by 2.15 points in the daily average on the BATES-JENSEN scale. It is concluded, therefore, that PBM can be a supportive therapy of clinical and economic interest in a hospital setting.


Assuntos
Terapia com Luz de Baixa Intensidade , Fraturas da Tíbia , Adulto , Humanos , Tíbia , Brasil , Saúde Pública , Fraturas da Tíbia/terapia , Custos e Análise de Custo , Análise Custo-Benefício
2.
Lima; IETSI; jul. 2022.
Não convencional em Espanhol | BRISA | ID: biblio-1551829

RESUMO

ANTECEDENTES En el marco de la metodología ad hoc para evaluar solicitudes de tecnologías sanitarias, aprobada mediante Resolución del Instituto de Evaluación de Tecnologías en Salud e Investigación N° 111-IETSI-ESSALUD-2021, se ha elaborado el presente dictamen preliminar sobre la evaluación de la eficacia y seguridad del sistema de clavo intramedular retrógrado (CIR) para artrodesis en pacientes adultos con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. Mediante la Nota N° 2761-GRPA-ESSALUD-2020, los médicos especialistas del Servicio II de Ortopedia del Hospital Guillermo Almenara Irigoyen (HNGAI), a través de la gerencia de su red prestacional, solicitan al Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI) la evaluación para incorporación del dispositivo "sistema de clavo intramedular retrógrado para artrodesis tibia-astrágalo-calcáneo". ASPECTOS GENERALES: Las patologías del tobillo' y retropié2, por lo general, pueden ser ocasionadas debido a traumatismo agudo o como secuela de alguna condición crónica (ógüt and Yontar 2017). Las fracturas y deformidades son dos de las condiciones patológicas que pueden ser identificadas con mayor frecuencia a este nivel. Se estima que aproximadamente un 70 % de las fracturas son unimaleolares3, 20 % bimaleolares4y un 10 % trimaleolares5 (Court-Brown, McBirnie, and Wilson 1998). Además, se reporta una tasa similar de fracturas según sexo; sin embargo, esto puede variar según diferentes grupos de edad (Daly et al. 1987). Por su parte, se reporta que algunas deformidades de tobillo, como la osteoartritis, están presentes en aproximadamente 13 millones de adultos mayores de 60 años en los Estados Unidos (Thomas et al. 2017). A nivel local, según información proporcionada por los especialistas del Servicio II de Ortopedia del HNGAI en los anexos de la solicitud, se presentan anualmente alrededor de 36 casos nuevos de pacientes que presentan fracturas complejas que involucran la tibia distal, el astrágalo y el calcáneo. METODOLOGÍA: Se realizó una búsqueda bibliográfica exhaustiva con el objetivo de identificar la mejor evidencia disponible sobre la eficacia y seguridad de la artrodesis con el sistema de CIR, en comparación con la artrodesis utilizando tornillos o fijación externa, en pacientes con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. La búsqueda bibliográfica8se realizó en las bases de datos de PubMed, The Cochrane Library y LILACS. Asimismo, se realizó una búsqueda manual en Google y dentro de las páginas web pertenecientes a grupos que realizan guías de práctica clínica (GPC) y evaluaciones de tecnologías sanitarias (ETS), incluyendo, el Instituto de Evaluación de Tecnologías en Salud e Investigación (IETSI), Centro Nacional de Excelencia Tecnológica en Salud (CENETEC), National Institute for Health and Care Excellence (NICE), Agency for Healthcare Research and Quality (AHRQ), Scottish Intercollegiate Guidelines Network (SIGN), The Guidelines International Network (GIN), National Health and Medical Research Council (NHMRC), Base Regional de Informes de Evaluación de Tecnologías en Salud de las Américas (BRISA), Comissáo Nacional de IncorporaQáo de Tecnologias no Sistema Único de Saúde (CONITEC), Instituto de Evaluación Tecnológica en Salud (IETS), Instituto de Efectividad Clínica y Sanitaria (IECS), Scottish Medicines Consortium (SMC), Canadian Agency for Drugs and Technologies in Health (CADTH), Instituto de Calidad y Eficiencia en la Atención de la Salud (IQWiG, por sus siglas en alemán), y Haute Autorité de Santé (HAS). RESULTADOS: Luego de la búsqueda bibliográfica con fecha 15 de febrero de 2022, se incluyeron para evaluación dos GPC orientadas al manejo de pacientes con fracturas del pie y tobillo: CENETEC e IMSS (Centro Nacional de Excelencia Tecnológica en Salud 2011, Instituto Mexicano del Seguro Social 2010); no se identificaron GPC orientadas al manejo de deformidades de la articulación tibia-astrágalo-calcáneo, o deformidades que involucran al pie, retropié y/o tobillo. Además, se incluyó un ECA (Georgiannos, Lampridis, and Bisbinas 2017) que evaluó la eficacia y seguridad del procedimiento de artrodesis con CIR, en comparación con las artrodesis con tornillos en pacientes con fracturas de tobillo. Asimismo, se incluyó el protocolo de un ECA (ACTRN12617001588381), el cual aún no cuenta con publicación de resultados, y tiene fecha aproximada de finalización en diciembre de 2022 (Tuckett et al. 2019). No se identificaron estudios que evalúen comparativamente al dispositivo CIR, y a la fijación externa en este tipo de 4,1;"147 procedimientos. CONCLUSIÓN: Por lo expuesto, el IETSI no aprueba el uso de clavo intramedular retrógrado para artrodesis en pacientes adultos con fracturas complejas y/o deformidades de la articulación tibia-astrágalo-calcáneo. El equipo evaluador del IETSI, está a la espera de nueva evidencia proveniente de ECA sobre la eficacia y seguridad de la tecnología solicitada. Por otro lado, se recomienda a los especialistas que, de tener conocimiento sobre otras tecnologías sanitarias que puedan representar un beneficio adicional a las tecnologías de uso actual en EsSalud para procedimientos de artrodesis en la población de interés, hagan envío de sus solicitudes para ser valoradas en nuevos documentos de ETS.


Assuntos
Humanos , Artrodese/instrumentação , Fraturas da Tíbia/terapia , Articulação Talocalcânea/lesões , Fixação Intramedular de Fraturas/instrumentação , Eficácia , Análise Custo-Benefício
3.
Expert Rev Pharmacoecon Outcomes Res ; 22(1): 139-145, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33890846

RESUMO

BACKGROUND: Fracture nonunions impact on morbidity and health care costs and are associated with substantial pain, reduced mobility, prolonged morbidity, and a lower quality of life. CMF OrthoLogic 1000 (OL1000) is a bone growth stimulator used to promote fracture healing potentially reducing the need for surgical intervention. A cost analysis comparing CMF OL1000 versus surgical care for patients with nonunion tibial fractures was conducted. METHODS: A Markov model was developed to compare the difference in costs between CMF OL1000 versus surgical care within the English National Health Service over a 2-year time horizon. The effectiveness of CMF OL1000 was based on recently published registry data. Cost data were derived from published sources and national cost databases. Sensitivity and scenario analyses were conducted. RESULTS: The use of CMF OL1000 is estimated to lead to cost-savings of £1,104 per patient, a reduction in average healing time of 2.1 months and a relative risk of infection of 0.19 compared to immediate surgical intervention (standard of care). The results of the model are robust to most changes in input parameters and scenarios considered. CONCLUSIONS: This early analysis shows cost-savings for CMF OL1000 compared with surgical intervention for individuals with nonunion tibial fractures.


Assuntos
Desenvolvimento Ósseo , Fenômenos Magnéticos , Medicina Estatal , Custos e Análise de Custo , Inglaterra , Fraturas não Consolidadas/terapia , Humanos , Medicina Estatal/economia , Fraturas da Tíbia/terapia
4.
Rev. medica electron ; 43(2): 3103-3119, mar.-abr. 2021. tab
Artigo em Espanhol | LILACS, CUMED | ID: biblio-1251929

RESUMO

RESUMEN Introducción: las fracturas de pilón tibial son un desafío para el cirujano y actualmente existe controversia en cuanto a su tratamiento. Objetivo: evaluar los resultados del tratamiento aplicado. Materiales y métodos: se realizó un estudio observacional, descriptivo, longitudinal, con el universo de estudio de todos los pacientes que fueron atendidos y tratados con fractura de pilón tibial desde el 1 de enero de 2015 al 31 de diciembre de 2016. Se seleccionó una muestra de 27 pacientes. Resultados: hubo un predominio del sexo masculino (78 %), y del grupo de edades de 40 a 49 años para ambos sexos (37 %). Prevalecieron las fracturas producidas por accidentes de tránsito, con 59 %. Las fracturas cerradas fueron las más representadas, con 78 %. El 67 % de los pacientes no presentaron lesiones asociadas y predominaron las fracturas tipo II en el 55 % del total. Se aplicó tratamiento quirúrgico a un 74 % y se logró la consolidación en un 78 % de los casos antes de las 16 semanas. Antes de las 20 semanas se le indicó el apoyo al 78 % de los casos. Se complicaron 13 pacientes, para un 48 % del total. A pesar de ello, como resultado final, fueron evaluados de excelente y bien el 63 % de los pacientes. Conclusiones: la fractura de pilón tibial constituye una lesión de muy difícil manejo para el cirujano traumatólogo de hoy (AU).


ABSTRACT Introduction: tibial pylon fractures are a challenge for the surgeon surgery and currently there is a controversy regarding their treatment. Objective: to assess the outcomes of the applied treatment. Materials and methods: an observational, descriptive, longitudinal study was carried out with the study universe of all the patients who were attended and treated with tibial pylon fracture from January 1st, 2015 to December 31st, 2016. A sample composed by 27 patients was chosen. Results: male sex (78 %) and both-sexes 40-49 age group (37 %) predominated. There was a predominance of fractures caused by traffic accidents with 59 %, being closed fractures the most represented ones, with 78 %. 67 % of the patients did not present associated injuries, being type II fractures predominant in 55 % of the total. 74 % of the cases underwent surgery, achieving consolidation in 78 % of the cases before 16 weeks. Before 20 weeks, 78 % of the cases were indicated to set on their foot, and 13 patients had complications, representing 48 % of the total. In spite of this, 63 % of the patients were evaluated as excellent and well as final outcome. Conclusions: the tibial pylon fracture is an injury of very difficult handling for the today's orthopedic surgeon (AU).


Assuntos
Humanos , Masculino , Feminino , Pacientes , Fraturas da Tíbia/terapia , Terapêutica/métodos , Fraturas da Tíbia/cirurgia , Cirurgiões Ortopédicos/normas , Fixação Interna de Fraturas/métodos
5.
JBJS Rev ; 8(4): e0186, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32304501

RESUMO

Although rare, tibial tubercle avulsion fracture must be considered in the differential diagnosis for the pediatric patient presenting with acute knee pain. In the adolescent population, tibial tubercle avulsion fracture is a rare injury that is typically seen in boys who engage in sporting activities that involve jumping or sprinting. The proximal tibial physis closes distally in the posteromedial to anterolateral direction, creating an environment that predisposes the tubercle to a potential avulsion injury. Historically, the Ogden classification has guided nonoperative and operative management of this condition. Multiple fracture fixation methods have been described with the overall goal of restoring the extensor mechanism and the joint surface.


Assuntos
Fratura Avulsão/terapia , Fraturas da Tíbia/terapia , Adolescente , Fratura Avulsão/complicações , Fratura Avulsão/diagnóstico por imagem , Fratura Avulsão/epidemiologia , Humanos , Redução Aberta , Radiografia , Tíbia/crescimento & desenvolvimento , Fraturas da Tíbia/complicações , Fraturas da Tíbia/diagnóstico por imagem , Fraturas da Tíbia/epidemiologia
6.
Acta Orthop Belg ; 86(2): 320-326, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-33418624

RESUMO

The aim of this study was to provide a detailed overview of age and gender specific health care costs and costs due to lost productivity for hospital admitted patients with an isolated tibia shaft fracture in The Netherlands between 2008 and 2012. Injury cases and length of hospital stay were extracted from the National Medical Registration. Information on extramural health care and work absence were retrieved from a patient follow-up survey on health care use. Medical costs included ambulance care, in- hospital care, general practitioner care, home care, physical therapy, and rehabilitation/nursing care. An incidence-based cost model was applied to calculate direct health care costs and lost productivity in 2012. Total direct health care costs for all patients admitted with a tibia shaft fracture (n = 1,635) were €13.6 million. Costs for productivity loss were € 23.0 million. Total costs (direct health care and lost productivity) per patient were highest for men aged 40-49 years mainly due to lost productivity, and for women aged > 80 years, due to high direct medical costs.


Assuntos
Carga Global da Doença/economia , Custos de Cuidados de Saúde/estatística & dados numéricos , Hospitalização , Licença Médica , Fraturas da Tíbia , Absenteísmo , Fatores Etários , Avaliação da Deficiência , Eficiência , Feminino , Hospitalização/economia , Hospitalização/estatística & dados numéricos , Humanos , Tempo de Internação/economia , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Países Baixos/epidemiologia , Aceitação pelo Paciente de Cuidados de Saúde/estatística & dados numéricos , Fatores Sexuais , Licença Médica/economia , Licença Médica/estatística & dados numéricos , Fraturas da Tíbia/economia , Fraturas da Tíbia/epidemiologia , Fraturas da Tíbia/terapia , Avaliação da Capacidade de Trabalho
7.
Phys Sportsmed ; 47(1): 47-59, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30345867

RESUMO

The purpose of this review is to describe and critically evaluate current knowledge regarding diagnosis, assessment, and management of chronic overload leg injuries which are often non-specific and misleadingly referred to as 'shin splints'. We aimed to review clinical entities that come under the umbrella term 'Exercise-induced leg pain' (EILP) based on current literature and systematically searched the literature. Specifically, systematic reviews were included. Our analyses demonstrated that current knowledge on EILP is based on a low level of evidence. EILP has to be subdivided into those with pain from bone stress injuries, pain of osteo-fascial origin, pain of muscular origin, pain due to nerve compression and pain due to a temporary vascular compromise. The history is most important. Questions include the onset of symptoms, whether worse with activity, at rest or at night? What exacerbates it and what relieves it? Is the sleep disturbed? Investigations merely confirm the clinical diagnosis and/or differential diagnosis; they should not be solely relied upon. The mainstay of diagnosing bone stress injury is MRI scan. Treatment is based on unloading strategies. A standard for confirming chronic exertional compartment syndrome (CECS) is the dynamic intra-compartmental pressure study performed with specific exercises that provoke the symptoms. Surgery provides the best outcome. Medial tibial stress syndrome (MTSS) presents a challenge in both diagnosis and treatment especially where there is a substantial overlap of symptoms with deep posterior CECS. Conservative therapy should initially aim to correct functional, gait, and biomechanical overload factors. Surgery should be considered in recalcitrant cases. MRI and MR angiography are the primary investigative tools for functional popliteal artery entrapment syndrome and when confirmed, surgery provides the most satisfactory outcome. Nerve compression is induced by various factors, e.g., localized fascial entrapment, unstable proximal tibiofibular joint (intrinsic) or secondary by external compromise of the nerve, e.g., tight hosiery (extrinsic). Conservative is the treatment of choice. The localized fasciotomy is reserved for recalcitrant cases.


Assuntos
Traumatismos em Atletas/diagnóstico , Traumatismos em Atletas/terapia , Traumatismos da Perna/diagnóstico , Traumatismos da Perna/terapia , Dor/etiologia , Síndrome do Compartimento Anterior/complicações , Síndrome do Compartimento Anterior/diagnóstico , Síndrome do Compartimento Anterior/terapia , Atletas , Traumatismos em Atletas/complicações , Síndromes Compartimentais/diagnóstico , Síndromes Compartimentais/cirurgia , Síndromes Compartimentais/terapia , Tratamento Conservador , Diagnóstico Diferencial , Exercício Físico/fisiologia , Fasciotomia , Fraturas de Estresse/complicações , Fraturas de Estresse/diagnóstico , Fraturas de Estresse/terapia , Humanos , Traumatismos da Perna/complicações , Masculino , Síndromes de Compressão Nervosa/complicações , Síndromes de Compressão Nervosa/diagnóstico , Síndromes de Compressão Nervosa/terapia , Dor/diagnóstico , Fraturas da Tíbia/complicações , Fraturas da Tíbia/diagnóstico , Fraturas da Tíbia/terapia
8.
Eur J Radiol ; 98: 36-40, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29279168

RESUMO

OBJECTIVES: To assess the value of a radiographic score for the detection of delayed union in nailed fractures. METHODS: The modified radiographic union score (mRUS) values were determined by three separate radiologists on 259 radiographic sets of 58 nailed tibial or femoral fractures obtained at different timepoints after fracture (mean of 4.5 radiographic sets per fracture). A surgeon determined fracture outcome (normal or delayed union) at a mean of 192days after injury. Mean radiographic scores obtained at different timepoints after fracture were compared between fractures with normal or abnormal healing at follow-up. RESULTS: The mean score values increased significantly over time for fractures with normal healing for all readers (p<0.001). The mean score values determined 11-14 weeks after injury were higher in fractures with normal healing than in fractures with delayed union at follow-up (p<0.05). Scoring of radiographs obtained at about 3 months after injury or later enabled detection of fractures with delayed union with a sensitivity of 0.63-0.77 and a specificity of 1.0 (area under curve: 0.77- 0.88). CONCLUSIONS: The mRUS score can contribute to the detection of delayed union at a delay of about 3 months after injury in nailed shaft fractures.


Assuntos
Fraturas do Fêmur/diagnóstico por imagem , Consolidação da Fratura , Fraturas da Tíbia/diagnóstico por imagem , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Fraturas do Fêmur/terapia , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Fraturas da Tíbia/terapia , Resultado do Tratamento , Adulto Jovem
9.
Bone Joint J ; 99-B(11): 1526-1532, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-29092994

RESUMO

AIMS: This 501-patient, multi-centre, randomised controlled trial sought to establish the effect of low-intensity, pulsed, ultrasound (LIPUS) on tibial shaft fractures managed with intramedullary nailing. We conducted an economic evaluation as part of this trial. PATIENTS AND METHODS: Data for patients' use of post-operative healthcare resources and time taken to return to work were collected and costed using publicly available sources. Health-related quality of life, assessed using the Health Utilities Index Mark-3 (HUI-3), was used to derive quality-adjusted life years (QALYs). Costs and QALYs were compared between LIPUS and control (a placebo device) from a payer and societal perspective using non-parametric bootstrapping. All costs are reported in 2015 Canadian dollars unless otherwise stated. RESULTS: With a cost per device of $3,995, the mean cost was significantly higher for patients treated with LIPUS versus placebo from a payer (mean increase = $3647, 95% confidence interval (CI) $3244 to $4070; p < 0.001) or a societal perspective (mean increase = $3425, 95% CI $1568 to $5283; p < 0.001). LIPUS did not provide a significant benefit in terms of QALYs gained (mean difference = 0.023 QALYs, 95% CI -0.035 to 0.069; p = 0.474). Incremental cost-effectiveness ratios of LIPUS compared with placebo were $155 433/QALY from a payer perspective and $146 006/QALY from a societal perspective. CONCLUSION: At the current price, LIPUS is not cost-effective for fresh tibial fractures managed with intramedullary nailing. Cite this article: Bone Joint J 2017;99-B:1526-32.


Assuntos
Análise Custo-Benefício , Fixação Intramedular de Fraturas , Custos de Cuidados de Saúde/estatística & dados numéricos , Anos de Vida Ajustados por Qualidade de Vida , Fraturas da Tíbia/terapia , Terapia por Ultrassom/economia , Ondas Ultrassônicas , Adulto , Idoso , Canadá , Terapia Combinada , Feminino , Seguimentos , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Estudos Prospectivos , Fraturas da Tíbia/economia , Terapia por Ultrassom/métodos
11.
Pan Afr Med J ; 25: 51, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-28250875

RESUMO

INTRODUCTION: Tibia/fibula fractures are one of the commonest admissions to the orthopaedic department at a resource-limited Northern Tanzanian hospital. These fractures are associated with poor prognosis and pose a huge socioeconomic burden on developing countries. However, to date there is a paucity of epidemiological data on lower-limb fractures in Tanzania. METHODS: A retrospective review of admissions to the orthopaedic department at Kilimanjaro Christian Medical Centre (KCMC) was completed between February 2015 and 2016. Inpatient record books were used to source epidemiological data which was subsequently analysed. RESULTS: 199 of the 1016 patients admitted sustained tibia/fibula fractures. 78% (n=156) of admissions were male and the most frequently affected age group was 21-30 years. Motor traffic accidents (MTAs) were the most common cause and accounted for 78% of fractures, with nearly half of these involving motorbikes (42%). Falls were identified as the second most common cause (13%). It was determined that 72% (n=143) of fractures were open, 19% (n=38) were comminuted and the most common site of injury was the distal-third of tibia/fibula. The most frequently recorded treatments were surgical toilet/debridement (66% of patients) and the application of a backslab (34% of patients). CONCLUSION: Males in the 21-30 age group, who were involved in MTAs, were most commonly affected by tibia/fibula fractures. Given that MTA incidence is increasing in Tanzania, there is a growing public health concern that this will be reflected by a step-increase in the number of people who sustain lower-limb fractures.


Assuntos
Fíbula/lesões , Fraturas Ósseas/epidemiologia , Fraturas da Tíbia/epidemiologia , Acidentes por Quedas/estatística & dados numéricos , Acidentes de Trânsito/estatística & dados numéricos , Adolescente , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Criança , Pré-Escolar , Feminino , Fraturas Ósseas/etiologia , Fraturas Ósseas/terapia , Hospitalização/estatística & dados numéricos , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Distribuição por Sexo , Tanzânia/epidemiologia , Fraturas da Tíbia/etiologia , Fraturas da Tíbia/terapia , Adulto Jovem
12.
Injury ; 46(11): 2267-72, 2015 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-26374949

RESUMO

Recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) is licensed in Europe for open tibia fractures treated with unreamed nails. However, there is limited data available on the specific use of rhBMP-2 in combination with unreamed nails for open tibia fractures. The intention of the current study was to evaluate the medical and health-economic effects of rhBMP-2 in Gustilo-Anderson grade III open tibia fractures treated with unreamed nails based on individual patient data from two previously published studies. Linear regression analysis was performed on raw data of 90 patients that were either treated by standard of care with soft tissue management and unreamed nailing (SOC group) (n=50) or with rhBMP-2 in addition to soft tissue management and unreamed nailing (rhBMP-2 group) (n=40). For all types of revision, a significant lower percentage of patients (27.5%) of the rhBMP-2 group had to be revised compared to 48% of the patients of the SOC group (p=0.04). When only invasive secondary interventions such as bone grafting and nail exchange were considered, there was also a statistically significant reduction in the rhBMP-2 group with a revision rate of 10.0% (4 of 40 patients) compared to the SOC group with a revision rate of 28.0% (14 of 50 patients) (p=0.01). Mean fracture healing time of 228 days in the rhBMP-2 compared to 266 days in the SOC group was not statistically significant (p=0.24). Health-economic analysis based on a societal perspective with calculation of overall treatment costs after initial surgery and including productivity losses revealed savings of €6,239 per patient for Germany and €4,752 for the UK in favour of rhBMP-2 which was mainly driven by reduction of productivity losses. In conclusion, rhBMP-2 reduces secondary interventions in patients with grade III open tibia fractures treated with an unreamed nail and its use leads to financial savings for Germany and the UK from a societal perspective.


Assuntos
Proteínas Morfogenéticas Ósseas/uso terapêutico , Fixação Intramedular de Fraturas/economia , Fraturas Expostas/terapia , Custos de Cuidados de Saúde/estatística & dados numéricos , Fraturas da Tíbia/terapia , Proteína Morfogenética Óssea 2 , Proteínas Morfogenéticas Ósseas/economia , Transplante Ósseo/economia , Análise Custo-Benefício , Feminino , Consolidação da Fratura , Fraturas Expostas/economia , Alemanha/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Reoperação/economia , Fraturas da Tíbia/economia , Resultado do Tratamento , Reino Unido/epidemiologia
13.
J Orthop Trauma ; 29(2): e60-4, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25099531

RESUMO

OBJECTIVES: What is the return to function after an isolated proximal humerus or tibial plafond fracture? DESIGN: Prospective observational. SETTING: Orthopaedic outpatient clinics. PATIENTS/PARTICIPANTS: Consecutive patients were enrolled with isolated proximal humerus (N = 155) and tibial plafond fractures (N = 120). INTERVENTION: None. MAIN OUTCOME MEASUREMENTS: Musculoskeletal Function Assessment. RESULTS: Patients who sustained isolated proximal humerus or tibial plafond fractures showed gradual improvement over 1 year. Women consistently demonstrated greater dysfunction than men at 6, 9, and 12 months after tibial plafond fracture. Age had an impact on return to function after injury for both fractures. Younger patients (18-29 years) with either type of injury tended to have better scores compared with the older patients. CONCLUSIONS: Detailed analysis of this data demonstrates variation in patient-based outcomes during recovery from a proximal humerus or tibial plafond fracture. These data need to be reviewed in the context of the individual patient when following a patient's recovery. LEVEL OF EVIDENCE: Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.


Assuntos
Fraturas do Ombro/terapia , Fraturas da Tíbia/terapia , Adolescente , Adulto , Traumatismos do Tornozelo/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Recuperação de Função Fisiológica , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
14.
Trials ; 15: 75, 2014 Mar 08.
Artigo em Inglês | MEDLINE | ID: mdl-24606670

RESUMO

BACKGROUND: Bone graft substitutes are widely used for reconstruction of posttraumatic bone defects. However, their clinical significance in comparison to autologous bone grafting, the gold-standard in reconstruction of larger bone defects, still remains under debate. This prospective, randomized, controlled clinical study investigates the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fractures-associated bone defects using either autologous bone grafting or bioresorbable hydroxyapatite/calcium sulphate cement (CERAMENT™|BONE VOID FILLER (CBVF)). METHODS/DESIGN: CERTiFy (CERament™ Treatment of Fracture defects) is a prospective, multicenter, controlled, randomized trial. We plan to enroll 136 patients with fresh traumatic depression fractures of the proximal tibia (types AO 41-B2 and AO 41-B3) in 13 participating centers in Germany. Patients will be randomized to receive either autologous iliac crest bone graft or CBVF after reduction and osteosynthesis of the fracture to reconstruct the subchondral bone defect and prevent the subsidence of the articular surface. The primary outcome is the SF-12 Physical Component Summary at week 26. The co-primary endpoint is the pain level 26 weeks after surgery measured by a visual analog scale. The SF-12 Mental Component Summary after 26 weeks and costs of care will serve as key secondary endpoints. The study is designed to show non-inferiority of the CBVF treatment to the autologous iliac crest bone graft with respect to the physical component of quality of life. The pain level at 26 weeks after surgery is expected to be lower in the CERAMENT bone void filler treatment group. DISCUSSION: CERTiFy is the first randomized multicenter clinical trial designed to compare quality of life, pain, and cost of care in the use of the CBVF and the autologous iliac crest bone graft in the treatment of tibia plateau fractures. The results are expected to influence future treatment recommendations. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: NCT01828905.


Assuntos
Substitutos Ósseos/uso terapêutico , Transplante Ósseo , Sulfato de Cálcio/uso terapêutico , Durapatita/uso terapêutico , Consolidação da Fratura/efeitos dos fármacos , Ílio/transplante , Projetos de Pesquisa , Fraturas da Tíbia/terapia , Substitutos Ósseos/efeitos adversos , Substitutos Ósseos/economia , Transplante Ósseo/efeitos adversos , Transplante Ósseo/economia , Sulfato de Cálcio/efeitos adversos , Sulfato de Cálcio/economia , Protocolos Clínicos , Análise Custo-Benefício , Combinação de Medicamentos , Durapatita/efeitos adversos , Durapatita/economia , Alemanha , Custos de Cuidados de Saúde , Humanos , Medição da Dor , Dor Pós-Operatória/etiologia , Estudos Prospectivos , Qualidade de Vida , Inquéritos e Questionários , Fraturas da Tíbia/diagnóstico por imagem , Fraturas da Tíbia/economia , Fraturas da Tíbia/cirurgia , Fatores de Tempo , Tomografia Computadorizada por Raios X , Transplante Autólogo , Resultado do Tratamento
15.
Injury ; 44(12): 1871-9, 2013 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-24074829

RESUMO

Current evidences show that recombinant human bone morphogenetic protein 7 (rhBMP-7, eptotermin alfa) can be considered an effective alternative to autologous bone graft (ABG) in the treatment of tibial nonunions. Few studies, so far, have analysed the costs of treating tibial nonunions with either rhBMP-7 or ABG and none of them has specifically considered the Italian situation. The aim of the present study was to capture, through observational retrospective methods, the direct medical costs associated with the treatment of tibial nonunions with rhBMP-7 or ABG in Italy and to compare the cost effectiveness of the two interventions. The secondary objective was to perform a cost-reimbursement analysis for hospitalisations associated with the two treatments. Data of 54 patients with indication for tibial nonunion were collected from existing data sources. Of these patients, 26 were treated with ABG and 28 with rhBMP-7. The study captured the direct medical costs for treating each tibial nonunion, considering both inpatient and outpatient care. The hospital reimbursement was calculated from discharge registries, based on diagnosis-related group (DRG) values. A subgroup of patients (n=30) was also interviewed to capture perceived health during the follow-up, and the quality-adjusted life years (QALYs) were subsequently computed. The two groups were similar for what concerns baseline characteristics. While the medical costs incurred during the hospitalisation associated with treatment were on average €3091.21 higher (P<0.001) in patients treated with rhBMP-7 (reflecting the product procurement costs), the costs incurred during the follow-up were on average €2344.45 higher (P=0.02) in patients treated with ABG. Considering all costs incurred from the treatment, there was a borderline statistical evidence (P=0.04) for a mean increase of €795.42, in the rhBMP-7 group. Furthermore, the study demonstrated that, without appropriate reimbursement, the hospital undergoes significant losses (P=0.003) when using rhBMP-7 instead of ABG. In contrast to these losses, in Italy, the average cost to achieve a successful outcome was €488.96 lower in patients treated with rhBMP-7 and, additionally, the cost per QALY gained was below the cost-utility threshold of $50,000.


Assuntos
Proteína Morfogenética Óssea 2/economia , Proteína Morfogenética Óssea 2/uso terapêutico , Transplante Ósseo/economia , Fixação Intramedular de Fraturas , Fraturas não Consolidadas/economia , Tempo de Internação/economia , Fraturas da Tíbia/economia , Protocolos Clínicos , Análise Custo-Benefício , Feminino , Seguimentos , Fixação Intramedular de Fraturas/economia , Fixação Intramedular de Fraturas/métodos , Consolidação da Fratura , Fraturas não Consolidadas/epidemiologia , Fraturas não Consolidadas/terapia , Custos de Cuidados de Saúde , Humanos , Itália/epidemiologia , Masculino , Readmissão do Paciente/economia , Anos de Vida Ajustados por Qualidade de Vida , Proteínas Recombinantes/economia , Proteínas Recombinantes/uso terapêutico , Estudos Retrospectivos , Fraturas da Tíbia/epidemiologia , Fraturas da Tíbia/terapia , Resultado do Tratamento
16.
Injury ; 44 Suppl 1: S34-9, 2013 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23351868

RESUMO

The management of open fractures and delayed or non unions continue to be complicated by high rates of treatment failure and significant patient disability and dissatisfaction. The use of bone morphogenetic proteins (BMPs) in the treatment of these injuries has been assessed by several authors. BMPs induce the process of bone healing by recruiting bone-forming cells to the area of lesion. The use of BMP currently has two FDA-approved indications: treatment of open tibial fractures treated with intramedullary fixation and treatment of tibia long bone non-union. Despite this limited target, off-label BMP use continues to push the spectrum for new applications. This review describes the current evidence for the use of BMPs in open fractures and non-unions.


Assuntos
Proteína Morfogenética Óssea 2/uso terapêutico , Proteína Morfogenética Óssea 7/uso terapêutico , Fixação Interna de Fraturas , Consolidação da Fratura , Fraturas Expostas/terapia , Fraturas não Consolidadas/terapia , Fraturas da Tíbia/terapia , Regeneração Óssea , Análise Custo-Benefício , Feminino , Fixação Interna de Fraturas/métodos , Fraturas Expostas/patologia , Fraturas não Consolidadas/patologia , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Fraturas da Tíbia/patologia , Resultado do Tratamento
19.
Int Orthop ; 36(4): 817-25, 2012 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-21505801

RESUMO

PURPOSE: This retrospective review follows 31 tibial nonunions to compare union at the docking site using closed versus open strategies. In this cohort of patients, all but five were infected nonunions. METHODS: Thirteen patients initially treated with single compression were compared with 18 patients treated by open revision of the docking site. In the single compression group, an average of 6.5 cm of bone was resected and index lengthening was 2.04. In the open revision group, a mean of 9.4 cm was resected and the index lengthening was 1.73. RESULTS: Consolidation at the docking site occurred in all subjects in both groups. There was no statistical difference between the two groups. Conclusive evidence of superiority of one modality of treatment over the other cannot be drawn from our data. CONCLUSIONS: The simple compression procedure requires less invasive surgery and is probably less demanding and more cost-effective in short transports.


Assuntos
Fixação Interna de Fraturas/métodos , Fraturas não Consolidadas/terapia , Manipulação Ortopédica , Osteogênese por Distração/métodos , Fraturas da Tíbia/terapia , Adulto , Idoso , Alongamento Ósseo , Análise Custo-Benefício , Feminino , Fixação Interna de Fraturas/economia , Consolidação da Fratura , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Osteogênese/fisiologia , Osteogênese por Distração/economia , Osteotomia , Reoperação , Reprodutibilidade dos Testes , Estudos Retrospectivos , Adulto Jovem
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