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1.
Cochrane Database Syst Rev ; 2: CD010569, 2020 Feb 07.
Artigo em Inglês | MEDLINE | ID: mdl-32031676

RESUMO

BACKGROUND: Hip fracture is a major injury that causes significant problems for affected individuals and their family and carers. Over 40% of people with hip fracture have dementia or cognitive impairment. The outcomes of these individuals after surgery are poorer than for those without dementia. It is unclear which care and rehabilitation interventions achieve the best outcomes for these people. This is an update of a Cochrane Review first published in 2013. OBJECTIVES: (a) To assess the effectiveness of models of care including enhanced rehabilitation strategies designed specifically for people with dementia following hip fracture surgery compared to usual care. (b) To assess for people with dementia the effectiveness of models of care including enhanced rehabilitation strategies that are designed for all older people, regardless of cognitive status, following hip fracture surgery, compared to usual care. SEARCH METHODS: We searched ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group Specialised Register, MEDLINE (OvidSP), Embase (OvidSP), PsycINFO (OvidSP), CINAHL (EBSCOhost), Web of Science Core Collection (ISI Web of Science), LILACS (BIREME), ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 16 October 2019. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials evaluating the effectiveness of any model of enhanced care and rehabilitation for people with dementia after hip fracture surgery compared to usual care. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion and extracted data. We assessed risk of bias of the included trials. We synthesised data only if we considered the trials to be sufficiently homogeneous in terms of participants, interventions, and outcomes. We used the GRADE approach to rate the overall certainty of evidence for each outcome. MAIN RESULTS: We included seven trials with a total of 555 participants. Three trials compared models of enhanced care in the inpatient setting with conventional care. Two trials compared an enhanced care model provided in inpatient settings and at home after discharge with conventional care. Two trials compared geriatrician-led care in-hospital to conventional care led by the orthopaedic team. None of the interventions were designed specifically for people with dementia, therefore the data included in the review were from subgroups of people with dementia or cognitive impairment participating in randomised controlled trials investigating models of care for all older people following hip fracture. The end of follow-up in the trials ranged from the point of acute hospital discharge to 24 months after discharge. We considered all trials to be at high risk of bias in more than one domain. As subgroups of larger trials, the analyses lacked power to detect differences between the intervention groups. Furthermore, there were some important differences in baseline characteristics of participants between the experimental and control groups. Using the GRADE approach, we downgraded the certainty of the evidence for all outcomes to low or very low. The effect estimates for almost all comparisons were very imprecise, and the overall certainty for most results was very low. There were no data from any study for our primary outcome of health-related quality of life. There was only very low certainty for our other primary outcome, activities of daily living and functional performance, therefore we were unable to draw any conclusions with confidence. There was low-certainty that enhanced care and rehabilitation in-hospital may reduce rates of postoperative delirium (odds ratio 0.04, 95% confidence interval (CI) 0.01 to 0.22, 2 trials, n = 141) and very low-certainty associating it with lower rates of some other complications. There was also low-certainty that, compared to orthopaedic-led management, geriatrician-led management may lead to shorter hospital stays (mean difference 4.00 days, 95% CI 3.61 to 4.39, 1 trial, n = 162). AUTHORS' CONCLUSIONS: We found limited evidence that some of the models of enhanced rehabilitation and care used in the included trials may show benefits over usual care for preventing delirium and reducing length of stay for people with dementia who have been treated for hip fracture. However, the certainty of these results is low. Data were available from only a small number of trials, and the certainty for all other results is very low. Determining the optimal strategies to improve outcomes for this growing population of patients should be a research priority.

2.
Bone Joint J ; 101-B(11): 1402-1407, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31674239

RESUMO

AIMS: Bone health assessment and the prescription of medication for secondary fracture prevention have become an integral part of the acute management of patients with hip fracture. However, there is little evidence regarding compliance with prescription guidelines and subsequent adherence to medication in this patient group. PATIENTS AND METHODS: The World Hip Trauma Evaluation (WHiTE) is a multicentre, prospective cohort of hip fracture patients in NHS hospitals in England and Wales. Patients aged 60 years and older who received operative treatment for a hip fracture were eligible for inclusion in WHiTE. The prescription of bone protection medications was recorded from participants' discharge summaries, and participant-reported use of bone protection medications was recorded at 120 days following surgery. RESULTS: Of 5456 recruited patients with baseline data, 2853 patients (52%) were prescribed bone protection medication at discharge, of which oral bisphosphonates were the most common, 4109 patients (75%) were prescribed vitamin D or calcium, and 606 patients (11%) were not prescribed anything. Of those prescribed a bone protection medication, only 932 patients (33%) reported still taking their medication 120 days later. CONCLUSION: These data provide a reference for current prescription and adherence rates. Adherence with oral medication remains poor in patients with hip fracture. Cite this article: Bone Joint J 2019;101-B:1402-1407.


Assuntos
Conservadores da Densidade Óssea/uso terapêutico , Fraturas do Quadril/cirurgia , Idoso , Cálcio/uso terapêutico , Estudos de Coortes , Denosumab/uso terapêutico , Difosfonatos/uso terapêutico , Humanos , Hidroxicolecalciferóis/uso terapêutico , Adesão à Medicação , Pessoa de Meia-Idade , Cuidados Pós-Operatórios/métodos , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Teriparatida/uso terapêutico , Reino Unido , Vitamina D/uso terapêutico
3.
Bone Joint J ; 101-B(10): 1292-1299, 2019 10.
Artigo em Inglês | MEDLINE | ID: mdl-31564146

RESUMO

AIMS: This study explores data quality in operation type and fracture classification recorded as part of a large research study and a national audit with an independent review. PATIENTS AND METHODS: At 17 centres, an expert surgeon reviewed a randomly selected subset of cases from their centre with regard to fracture classification using the AO system and type of operation performed. Agreement for these variables was then compared with the data collected during conduct of the World Hip Trauma Evaluation (WHiTE) cohort study. Both types of surgery and fracture classification were collapsed to identify the level of detail of reporting that achieved meaningful agreement. In the National Hip Fracture Database (NHFD), the types of operation and fracture classification were explored to identify the proportion of "highly improbable" combinations. RESULTS: The records were reviewed for 903 cases. Agreement for the subtypes of extracapsular fracture was poor; most centres achieved no better than "fair" agreement. When the classification was collapsed to a single option for "extracapsular" fracture, only four centres failed to have at least "moderate" agreement. There was only "moderate" agreement for the subtypes of intracapsular fracture, which improved to "substantial" when collapsed to "intracapsular". Subtrochanteric fracture types were well reported with "substantial" agreement. There was near "perfect" agreement for internal fixation procedures. "Perfect" or "substantial" agreement was achieved when the type of arthroplasty surgery was reported at the level of "hemiarthroplasty" and "total hip replacement". When reviewing data submitted to the NHFD, a minimum of 5.2% of cases contained "highly improbable" procedures for the stated fracture classification. CONCLUSION: The complexity of collecting fracture classification data at a national scale compromises the accuracy with which detailed classification systems can be reported. Data around type of surgery performed show similar tendencies. Data capture, reporting, and interpretation in future studies must take this into account. Cite this article: Bone Joint J 2019;101-B:1292-1299.


Assuntos
Artroplastia de Quadril/métodos , Fixação Interna de Fraturas/métodos , Hemiartroplastia/métodos , Fraturas do Quadril/classificação , Fraturas do Quadril/cirurgia , Reoperação/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Estudos de Coortes , Confiabilidade dos Dados , Inglaterra , Feminino , Fixação Interna de Fraturas/efeitos adversos , Consolidação da Fratura/fisiologia , Hemiartroplastia/efeitos adversos , Humanos , Masculino , Auditoria Médica , Pessoa de Meia-Idade , Complicações Pós-Operatórias/fisiopatologia , Complicações Pós-Operatórias/cirurgia , Prognóstico , Amplitude de Movimento Articular/fisiologia , Reoperação/métodos , Resultado do Tratamento , País de Gales
4.
Health Technol Assess ; 23(51): 1-132, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31549959

RESUMO

BACKGROUND: Fractures of the distal femur are an increasingly common injury; the optimal management of these injuries remains controversial. The two interventions used in UK practice are intramedullary fixation, with a locked retrograde nail, and extramedullary fixation, with a fixed angle plate. OBJECTIVES: This study assessed the feasibility of a definitive trial and included a process evaluation to understand the generalisability and likely success of a future trial. DESIGN: A multicentre, parallel, two-arm, randomised controlled feasibility trial with an embedded process evaluation. Treatment with a plate or nail was allocated in a 1 : 1 ratio, stratified by centre and chronic cognitive impairment. Surgeons were not blinded, but participants were not told their allocation. SETTING: Seven NHS hospitals. PARTICIPANTS: Patients aged ≥ 18 years with a fracture of the distal femur who the attending surgeon believed would benefit from internal fixation were potentially eligible. Patients were excluded if they had a loose arthroplasty requiring revision or a femoral deformity or arthroplasty that precluded nail fixation. The sample was recruited between 29 September 2016 and 31 August 2017. Consent was obtained from the patient or appropriate consultee before enrolment. INTERVENTIONS: Patients were randomised to receive fixation of their distal femur fracture with either a proximally and distally locked retrograde nail that spanned the diaphysis of the femur or an anatomical distal femoral locking plate with at least one locked screw distal to the fracture. Reduction and supplemental fixation were at the surgeon's discretion. OUTCOMES: The primary outcome measures for this study were the recruitment rate and the completion rate of the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), at 6 weeks and 4 months. Additional measurements included baseline characteristics, measures of social support and self-efficacy, disability rating index, dementia quality-of-life measures and a radiographical assessment of any malunion. Participants' and staff views were obtained, at interview, for the process evaluation. RESULTS: The process evaluation showed that surgeon-related factors, principally confidence with both technologies and a lack of individual equipoise, were key barriers to recruitment. A total of 23 participants were randomised and analysed (nail, n = 11; plate, n = 12). The recruitment rate was estimated as 0.42 [95% confidence interval (CI) 0.27 to 0.62] participants per centre per month, lower than the prespecified feasibility threshold of 1.0 participants per centre per month. Data completeness of the EQ-5D-5L was estimated at 65% (95% CI 43% to 83%). CONCLUSIONS: This feasibility study has challenged many of the assumptions that underpinned the development of proposed definitive trial protocol. A modified protocol is proposed that would be feasible given the recruitment rate observed here, which is equal to that reported in the similar FixDT trial [Health Technology Assessment (HTA) 11/136/04: Costa ML, Achten J, Hennings S, Boota N, Griffin J, Petrou S, et al. Intramedullary nail fixation versus locking plate fixation for adults with a fracture of the distal tibia: the UK FixDT RCT. Health Technol Assess 2018;22(25)], which delivered to target and budget. FUTURE WORK: A definitive trial with a modified design is recommended, including an internal pilot to confirm initial recruitment rate assumptions. REGISTRATION: Current Controlled Trials ISRCTN92089567. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 51. See the NIHR Journals Library website for further project information. Funding was also supported by the NIHR Oxford Biomedical Research Centre.

5.
Lancet Haematol ; 6(10): e530-e539, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31444124

RESUMO

BACKGROUND: Hospital-associated venous thromboembolism is a major patient safety concern. Provision of prophylaxis to patients admitted for elective total knee replacement surgery has been proposed as an effective strategy to reduce the incidence of venous thromboembolism. We aimed to assess the relative efficacy and safety of all available prophylaxis strategies in this setting. METHODS: We did a systematic review and Bayesian network meta-analyses of randomised controlled trials to assess the relative efficacy and safety of venous thromboembolism prophylaxis strategies and to populate an economic model that assessed the cost-effectiveness of these strategies and informed the updated National Institute for Health and Care Excellence (NICE) guideline recommendations for patients undergoing elective total knee replacement surgery. The Cochrane Library (CENTRAL), Embase, and Medline were last searched on June 19, 2017, with key terms relating to the population (venous thromboembolism and total knee replacement) and the interventions compared, including available pharmacological and mechanical interventions. Outcomes of interest were deep vein thrombosis (symptomatic and asymptomatic), pulmonary embolism, and major bleeding. Risk of bias was assessed, and relevant data extracted from the included randomised controlled trials for the network meta-analyses. Relative risks (RR; with 95% credible intervals [95% CrI]) compared to no prophylaxis, median ranks (with 95% CrI), and the probability of being the best intervention were calculated. The study was done in accordance with PRISMA guidelines. FINDINGS: 25 randomised controlled trials were included in the network meta-analyses. 23 trials (19 interventions; n=15 028) were included in the deep vein thrombosis network, 12 in the pulmonary embolism network (13 interventions; n=15 555), and 19 in the major bleeding network (11 interventions; n=19 797). Risk of bias ranged from very low to high. Rivaroxaban ranked first for prevention of deep vein thrombosis (RR 0·12 [95% CrI 0·06-0·22]). Low molecular weight heparin (LMWH; standard prophylactic dose, 28-35 days) ranked first in the pulmonary embolism network (RR 0·02 [95% CrI 0·00-3·86]) and LMWH (low prophylactic dose, 10-14 days) ranked first in the major bleeding network (odds ratio 0·08 [95% CrI 0·00-1·76]), but the results for pulmonary embolism and major bleeding are highly uncertain. INTERPRETATION: Single prophylaxis strategies are more effective in prevention of deep vein thrombosis in the elective total knee replacement population than combination strategies, with rivaroxaban being the most effective. The results of the pulmonary embolism and major bleeding meta-analyses are uncertain and no clear conclusion can be made other than what is biologically plausible (eg, that no prophylaxis and mechanical prophylaxis strategies should have the lowest risk of major bleeding). FUNDING: National Institute for Health and Care Excellence.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/efeitos adversos , Artroplastia do Joelho , Hemorragia/etiologia , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Razão de Chances , Risco , Tromboembolia Venosa/patologia
6.
BMJ Open ; 9(5): e026810, 2019 05 05.
Artigo em Inglês | MEDLINE | ID: mdl-31061043

RESUMO

OBJECTIVES: This feasibility study and process evaluation assessed the likely success of a definitive trial of intramedullary fixation with locked retrograde nails versus extramedullary fixation with fixed angle plates for fractures of the distal femur. DESIGN & SETTING: A multicentre, parallel, two-arm, randomised controlled feasibility study with an embedded process evaluation was conducted at seven NHS hospitals in England. Treatment was randomly allocated in 1:1 ratio, stratified by centre and chronic cognitive impairment. Participants, but not surgeons or research staff, were blinded to the allocation. PARTICIPANTS: Patients 18 years and older with a fracture of the distal femur, who their surgeon believed would benefit from internal fixation, were eligible to take part.Participants were allocated to receive either a retrograde intramedullary nail or an anatomical locking plate. OUTCOMES: The primary outcomes for this feasibility study were the recruitment rate and completion rate of the EQ-5D-5L at 4 months post-randomisation. Baseline characteristics, disability rating index, quality of life scores, measurements of social support and self-efficacy, resource use and radiographic assessments were also collected. The views of patients and staff were collected during interviews. RESULTS: Recruitment and data completion were lower than expected. 23 of 82 eligible patients were recruited (nail, 11; plate, 12). The recruitment rate was estimated as 0.42 (95% CI 0.27 to 0.62) participants per centre-month. Data completeness of the EQ-5D-5L at 4 months was 61 per cent (95% CI 43% to 83%). The process evaluation demonstrated that the main barriers to recruitment were variation in treatment pathways across centres, lack of surgeon equipoise and confidence in using both interventions and newly formed research cultures that lacked cohesion. CONCLUSIONS: A modified trial design, with embedded recruitment support intervention, comparing functional outcome in cognitively intact adults who have sustained a fragility fracture of the distal femur is feasible. ETHICS APPROVAL: The Wales Research Ethics Committee 5 approved the study (ref: 16/WA/0225). TRIAL REGISTRATION NUMBER: ISRCTN92089567; Pre-results.

7.
Hip Int ; 29(1): 77-82, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29734844

RESUMO

INTRODUCTION:: High-energy femoral neck fractures in young patients can be devastating, with the risk of osteonecrosis, nonunion, malunion and lifelong morbidity. The aim of this study is to define the effects of patient, fracture and surgical factors on the outcome of high-energy femoral neck fractures in patients aged from 15 to 50 years. METHODS:: A retrospective review was conducted of high-energy femoral neck fractures in patients aged 15-50 managed surgically at a Level 1 Trauma Centre, using a prospectively recorded trauma database. Low energy trauma (including falls from <1 m), medical conditions adversely affecting bone density, and pathological fractures were excluded. A clinical and radiological review was performed. The primary outcome measures were the development of osteonecrosis or nonunion leading to total hip arthroplasty (THA). Secondary outcome measures included osteotomy or other surgical procedures, quality of reduction and malunion. RESULTS:: 32 patients meeting the inclusion criteria were identified between January 2008 and July 2015. The mean follow-up was 58.5 months (range 980-3,048 days). 3 patients (9.4%) required THA. No other surgical procedures were performed. None of the 29 other patients developed radiologically apparent osteonecrosis. Fracture type, displacement, anatomical reduction and fixation type were not statistically significant risk factors affecting these outcomes. For all patients, an average of 8% loss of femoral neck height and 10% femoral neck offset were seen. CONCLUSIONS:: At a mean 4.9-year follow-up, the incidence of high-energy femoral neck fractures leading to THA was 9.4%, as a consequence of osteonecrosis or nonunion. Malunion was common.


Assuntos
Fraturas do Colo Femoral/cirurgia , Fixação de Fratura/efeitos adversos , Osteonecrose/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Adolescente , Adulto , Fatores Etários , Artroplastia de Quadril , Feminino , Fraturas do Colo Femoral/etiologia , Fixação de Fratura/métodos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Osteonecrose/cirurgia , Complicações Pós-Operatórias/cirurgia , Radiografia , Estudos Retrospectivos , Fatores de Risco , Resultado do Tratamento , Adulto Jovem
8.
Front Pharmacol ; 9: 1370, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30564117

RESUMO

Background: Major orthopedic surgery, such as elective total hip replacement (eTHR) and elective total knee replacement (eTKR), are associated with a higher risk of venous thromboembolism (VTE) than other surgical procedures. Little is known, however, about the cost-effectiveness of VTE prophylaxis strategies in people undergoing these procedures. Aim: The aim of this work was to assess the cost-effectiveness of these strategies from the English National Health Service perspective to inform NICE guideline (NG89) recommendations. Materials and Methods: Cost-utility analysis, using decision modeling, was undertaken to compare 15 VTE prophylaxis strategies for eTHR and 12 for eTKR, in addition to "no prophylaxis" strategy. The analysis complied with the NICE Reference Case. Structure and assumptions were agreed with the guideline committee. Incremental net monetary benefit (INMB) was calculated, vs. the model comparator (LMWH+ antiembolism stockings), at a threshold of £20,000/quality-adjusted life-year (QALY) gained. The model was run probabilistically. Deterministic sensitivity analyses (SAs) were undertaken to assess the robustness of the results. Results: The most cost-effective strategies were LMWH for 10 days followed by aspirin for 28 days (INMB = £530 [95% CI: -£784 to £1,103], probability of being most cost-effective = 72%) for eTHR, and foot pump (INMB = £353 [95% CI: -£101 to £665]; probability of being most cost-effective = 18%) for eTKR. There was considerable uncertainty regarding the cost-effectiveness ranking in the eTKR analysis. The results were robust to change in all SAs. Conclusions: For eTHR, LMWH (standard dose) for 10 days followed by aspirin for 28 days is the most cost-effective VTE prophylaxis strategy. For eTKR, the results are highly uncertain but foot pump appeared to be the most cost-effective strategy, followed closely by aspirin (low dose). Future research should focus on assessing cost-effectiveness of VTE prophylaxis in the eTKR population.

9.
BMJ Open ; 8(1): e019944, 2018 01 26.
Artigo em Inglês | MEDLINE | ID: mdl-29374679

RESUMO

INTRODUCTION: Sliding hip screw fixation is well established in the treatment of trochanteric fractures of the hip. The X-Bolt Dynamic Hip Plating System builds on the successful design features of the sliding hip screw but differs in the nature of the fixation in the femoral head. A randomised pilot study suggested that the X-bolt Dynamic Hip Plating System might provide similar health-related quality of life while reducing the risk of revision surgery when compared with the sliding hip screw. This is the protocol for a multicentre randomised trial of sliding hip screw versus X-Bolt Dynamic Hip Plating System for patients 60 years and over treated for a trochanteric fracture of the hip. METHODS AND ANALYSIS: Multicentre, multisurgeon, parallel, two-arm, randomised controlled trial. Patients aged 60 years and older with a trochanteric hip fracture are potentially eligible. Participants will be randomly allocated on a 1:1 basis to either sliding hip screw or X-Bolt Dynamic Hip Plating System. Otherwise, all care will be in accordance with National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in EuroQol-5D health-related quality of life at 4 months postrandomisation. Secondary outcomes include mortality, residential status, revision surgery and radiographic measures. The treatment effect will be estimated using a two-sided t-test adjusted for age, gender and cognitive impairment based on an intention-to-treat analysis. ETHICS AND DISSEMINATION: National Research Ethics Committee approved this study on 5 February 2016 (16/WM/0001). The study is sponsored by the University of Oxford and funded through an investigator initiated grant by X-Bolt Orthopaedics. A manuscript for a high-impact peer-reviewed journal will be prepared, and the results will be disseminated to patients through local mechanisms at participating centres. TRIAL REGISTRATION NUMBER: ISRCTN92825709.


Assuntos
Placas Ósseas , Parafusos Ósseos , Fixação Intramedular de Fraturas/métodos , Fraturas do Quadril/cirurgia , Idoso , Idoso de 80 Anos ou mais , Feminino , Fixação Intramedular de Fraturas/efeitos adversos , Fraturas do Quadril/mortalidade , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Qualidade de Vida , Reoperação/estatística & dados numéricos , Projetos de Pesquisa , Resultado do Tratamento , Reino Unido
10.
Trials ; 18(1): 538, 2017 Nov 14.
Artigo em Inglês | MEDLINE | ID: mdl-29137679

RESUMO

BACKGROUND: Distal femoral fractures are a source of considerable morbidity and best treatment is currently uncertain. The Trial of Acute Femoral Fracture Fixation (TrAFFix) is a randomised, parallel-group feasibility study designed to inform the design of a later, definitive clinical trial comparing intramedullary nails and locking plates for the treatment of distal femoral fractures. METHODS/DESIGN: Patients aged 50 years and older with a femoral fracture within the distal two Müller squares are potentially eligible for inclusion. Participants are randomly allocated to receive fixation with either an intramedullary nail or a distal locking plate. Measurements (EuroQol 5 Dimensions, Dementia Quality of Life, Disability Rating Index) are collected at baseline, 6 weeks and 4 months. The recruitment rate will be assessed across seven participating centres over a total of 52 centre-months which is expected after 10 months of recruitment. Objectives are - feasibility phase, to assess recruitment rate and completion rate of the primary outcome measure; process evaluation, to assess the generalisability and likely success of a future trial; definitive trial, quantify and draw inferences on observed differences in health-related quality of life at 4 months between the study intervention groups (nail versus plate). A favourable opinion was granted by the Wales Research Ethics Committee (16/WA/0225), study-wide NHS approval was given by the Health Research Authority (IRAS 206745), and participating NHS trusts provided local approvals. This study was funded by the National Institute for Health Research Health Technology Assessment (HTA 15/59/22). DISCUSSION: This is the protocol for a feasibility study conducted prior to any future definitive trial. The estimates of participant recruitment rate and proportion of data completion will be coupled with outputs from the process evaluation to make a final decision regarding feasibility TRIAL REGISTRATIONS: The study is registered with the National Institute for Health Research Portfolio (CPMS ID: 32536) and the ISRCTN registry ( ISRCTN92089567 ) on 26 May 2016.


Assuntos
Fraturas do Fêmur/cirurgia , Fixação Interna de Fraturas/métodos , Pinos Ortopédicos , Placas Ósseas , Protocolos Clínicos , Inglaterra , Estudos de Viabilidade , Feminino , Fraturas do Fêmur/diagnóstico por imagem , Fraturas do Fêmur/fisiopatologia , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/instrumentação , Consolidação da Fratura , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Recuperação de Função Fisiológica , Projetos de Pesquisa , Fatores de Tempo , Resultado do Tratamento
11.
Hip Int ; 27(5): 415-424, 2017 Sep 19.
Artigo em Inglês | MEDLINE | ID: mdl-28956892

RESUMO

Neck of femur fractures are occurring at an increased incidence. Functionally independent patients without cognitive impairment can expect reasonable life expectancy. This indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. Most fractures are displaced. Surgical options include internal fixation, hemiarthroplasty or total hip arthroplasty (THA). Evidence is conclusive that arthroplasty options outperform internal fixation in terms of function, quality of life and reoperation rates. In anyone other than young patients where head preserving surgery is required, arthroplasty is the standard of care. Hemiarthroplasty is the heavily favoured arthroplasty option for surgeons. However, in patients other than the extreme elderly, medically infirm, neurologically impaired, or with little or no ambulatory capacity, the evidence to support hemiarthroplasty is lacking. In functionally independent patients without cognitive impairment, THA should be considered the gold standard, producing better functional and quality of life outcomes, lower reoperation rates and better cost effectiveness, with no difference in complications or mortality. An increased risk of dislocation does exist. This may be reduced with modern surgical technique and implant options. Low amounts of research have been afforded to undisplaced fractures. For this fracture type, surgery is the standard of care. Despite a higher risk of reoperation, internal fixation is the preferred option for all age groups. Further study is required to identify the difference between internal fixation and THA, in particular, for unstable fracture patterns in elderly patients.


Assuntos
Artroplastia de Quadril/métodos , Fraturas do Colo Femoral/cirurgia , Fixação Interna de Fraturas/métodos , Qualidade de Vida , Humanos , Reoperação , Resultado do Tratamento
12.
BMJ Open ; 6(10): e011679, 2016 10 21.
Artigo em Inglês | MEDLINE | ID: mdl-27797994

RESUMO

INTRODUCTION: Osteoporotic hip fractures present a significant global challenge to patients, clinicians and healthcare systems. It is estimated that hip fracture accounts for 1.4% of total social and healthcare costs in the established market economies. METHODS AND ANALYSIS: The World Hip Trauma Evaluation (WHiTE) was set up to measure outcome in a comprehensive cohort of UK patients with hip fracture. All patients in the cohort are treated under a single comprehensive treatment pathway. A core outcome set, including health-related quality of life, is collected on all the patients. This protocol describes the current multicentre project that will be used as a vehicle to deliver a series of embedded observational studies. ETHICS AND DISSEMINATION: Research Ethics Committee approval was granted (Rec reference 11/LO/0927, approved 18/8/2011) and each hospital trust provided National Health Service (NHS) approvals. TRIAL REGISTRATION NUMBER: The study is registered with National Institute of Health Research Portfolio (UKCRN ID 12351) and the ISRCTN registry (ISRCTN63982700).


Assuntos
Assistência à Saúde , Fraturas do Quadril/terapia , Articulação do Quadril , Quadril , Osteoporose/complicações , Estudos de Coortes , Feminino , Fraturas do Quadril/etiologia , Humanos , Masculino , Qualidade de Vida , Projetos de Pesquisa , Reino Unido
13.
BMJ ; 353: i2021, 2016 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-27122469

RESUMO

OBJECTIVES: To determine whether the use of total hip arthroplasty (THA) among individuals with a displaced intracapsular fracture of the femoral neck is based on national guidelines or if there are systematic inequalities. DESIGN: Observational cohort study using the National Hip Fracture Database (NHFD). SETTING: All hospitals that treat adults with hip fractures in England, Wales, and Northern Ireland. PARTICIPANTS: Patients within the national database (all aged ≥60) who received operative treatment for a non-pathological displaced intracapsular hip fracture from 1 July 2011 to 31 April 2015. MAIN OUTCOME MEASURES: Provision of THA to patients considered eligible under criteria published by the National Institute for Health and Care Excellence (NICE). RESULTS: 114 119 patients with hip fracture were included, 11 683 (10.2%) of whom underwent THA. Of those who satisfied the NICE criteria, 32% (6780) : received a THA. Of patients who underwent THA, 42% (4903) did not satisfy the NICE criteria. A recursive partitioning algorithm found that the NICE eligibility criteria did not optimally explain which patients underwent THA. A model with superior explanatory power drew distinctions that are not supported by NICE, which were an age cut off at 76 and a different ambulation cut off. Among patients who satisfied the NICE eligibility, the use of THA was less likely with higher age (odds ratio 0.88, 95% confidence interval 0.87 to 0.88), worsening abbreviated mental test scores (0.49 (0.41 to 0.58) for normal cognition v borderline cognitive impairment)), worsening American Society of Anesthesiologists score (0.74, 0.66 to 0.84), male sex (0.85, 0.77 to 0.93), worsening ambulatory status (0.32, 0.28 to 0.35 for walking with a stick v independent ambulation), and fifths of worsening socioeconomic area deprivation (0.76 (0.66 to 0.88) for least v most deprived fifth). Patients receiving treatment during the working week were more likely to receive THA than at the weekend (0.90, 0.83 to 0.98). CONCLUSIONS: There are wide disparities in the use of THA among individuals with hip fractures, and compliance with NICE guidance is poor. Patients with higher levels of socioeconomic deprivation and those who require surgery at the weekend were less likely to receive THA. Inconsistent compliance with NICE recommendations means that the optimal treatment for older adults with hip fractures can depend on where and when they present to hospital.


Assuntos
Artroplastia de Quadril/estatística & dados numéricos , Fraturas do Colo Femoral/cirurgia , Disparidades em Assistência à Saúde/estatística & dados numéricos , Fatores Socioeconômicos , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Bases de Dados Factuais , Inglaterra , Feminino , Guias como Assunto , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Irlanda do Norte , País de Gales
14.
J Orthop Traumatol ; 16(4): 275-85, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26307153

RESUMO

BACKGROUND: It is uncertain whether external fixation or open reduction internal fixation (ORIF) is optimal for patients with bicondylar tibial plateau fractures. MATERIALS AND METHODS: A systematic review using Ovid MEDLINE, Embase Classic, Embase, AMED, the Cochrane Library, Open Grey, Orthopaedic Proceedings, WHO International Clinical Trials Registry Platform, Current Controlled Trials, US National Institute for Health Trials Registry, and the Cochrane Central Register of Controlled Trials. The search was conducted on 3rd October 2014 and no language limits were applied. Inclusion criteria were all clinical study designs comparing external fixation with open reduction internal fixation of bicondylar tibial plateau fractures. Studies of only one treatment modality were excluded, as were those that included unicondylar tibial plateau fractures. Treatment effects from studies reporting dichotomous outcomes were summarised using odds ratios. Continuous outcomes were converted to standardized mean differences to assess the treatment effect, and inverse variance methods used to combine data. A fixed effect model was used for meta-analyses. RESULTS: Patients undergoing external fixation were more likely to have returned to preinjury activities by six and twelve months (P = 0.030) but not at 24 months follow-up. However, external fixation was complicated by a greater number of infections (OR 2.59, 95 % CI 1.25-5.36, P = 0.01). There were no statistically significant differences in the rates of deep infection, venous thromboembolism, compartment syndrome, or need for re-operation between the two groups. CONCLUSION: Although external fixation and ORIF are associated with different complication profiles, both are acceptable strategies for managing bicondylar tibial plateau fractures.


Assuntos
Fixação de Fratura/métodos , Fraturas da Tíbia/cirurgia , Fixadores Externos , Fixação Interna de Fraturas , Humanos
15.
Cochrane Database Syst Rev ; (8): CD010606, 2015 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-26270891

RESUMO

BACKGROUND: Fractures of the distal femur (the part of the thigh bone nearest the knee) are a considerable cause of morbidity. Various different surgical and non-surgical treatments have been used in the management of these injuries but the best treatment remains controversial. OBJECTIVES: To assess the effects (benefits and harms) of interventions for treating fractures of the distal femur in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (9 September 2014); the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2014, Issue 8); MEDLINE (1946 to August week 4 2014); EMBASE (1980 to 2014 week 36); World Health Organization (WHO) International Clinical Trials Registry Platform (January 2015); conference proceedings and reference lists without language restrictions. SELECTION CRITERIA: Randomised and quasi-randomised controlled clinical trials comparing interventions for treating fractures of the distal femur in adults. Our primary outcomes were patient-reported outcome measures (PROMs) of knee function and adverse events, including re-operations. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies and performed data extraction and risk of bias assessment. We assessed treatment effects using risk ratios (RR) or mean differences (MD) and, where appropriate, we pooled data using a fixed-effect model. MAIN RESULTS: We included seven studies that involved a total of 444 adults with distal femur fractures. Each of the included studies was small and assessed to be at substantial risk of bias, with four studies being quasi-randomised and none of the studies using blinding in outcome assessment. All studies provided an incomplete picture of outcome. Based on GRADE criteria, we assessed the quality of the evidence as very low for all reported outcomes, which means we are very uncertain of the reliability of these results.One study compared surgical (dynamic condylar screw (DCS) fixation) and non-surgical (skeletal traction) treatment in 42 older adults (mean age 79 years) with displaced fractures of the distal femur. This study, which did not report on PROMs, provided very low quality evidence of little between-group differences in adverse events such as death (2/20 surgical versus 1/20 non-surgical), re-operation or repeat procedures (1/20 versus 3/20) and other adverse effects including delayed union. However, while none of the findings were statistically significant, there were more complications such as pressure sores (0/20 versus 4/20) associated with prolonged immobilisation in the non-surgical group, who stayed on average one month longer in hospital.The other six studies compared different surgical interventions. Three studies, including 159 participants, compared retrograde intramedullary nail (RIMN) fixation versus DCS or blade-plate fixation (fixed-angle devices). None of these studies reported PROMS relating to function. None of the results for the reported adverse events showed a difference between the two implants. Thus, although there was very low quality evidence of a higher risk of re-operation in the RIMN group, the 95% confidence interval (CI) also included the possibility of a higher risk of re-operation for the fixed-angle device (9/83 RIMN versus 4/96 fixed-angle device; 3 studies: RR 1.85, 95% CI 0.62 to 5.57). There was no clinically important difference between the two groups found in quality of life assessed using the 36-item Short Form in one study (23 fractures).One study (18 participants) provided very low quality evidence of there being little difference in adverse events between RIMN and non-locking plate fixation. One study (53 participants) provided very low quality evidence of a higher risk of re-operation after locking plate fixation compared with a single fixed-angle device (6/28 locking plate versus 1/25 fixed-angle device; RR 5.36, 95% CI 0.69 to 41.50); however, the 95% CI also included the possibility of a higher risk of re-operation for the fixed-angle device. Neither of these trials reported on PROMs.The largest included study, which reported outcomes in 126 participants at one-year follow-up, compared RIMN versus locking plate fixation; both implants are commonly used in current practice. None of the between-group differences in the reported outcomes were statistically significant; thus the CIs crossed the line of no effect. There was very low quality evidence of better patient-reported musculoskeletal function in the RIMN group based on Short Musculoskeletal Function Assessment (0 to 100: best function) scores (e.g. dysfunction index: MD -5.90 favouring RIMN, 95% CI -15.13 to 3.33) as well as quality of life using the EuroQoL-5D Index (0 to 1: best quality of life) (MD 0.10 favouring RIMN, 95% CI -0.01 to 0.21). The CIs for both results included a clinically important effect favouring RIMN but also a clinically insignificant effect in favour of locking plate fixation. AUTHORS' CONCLUSIONS: This review highlights the major limitations of the available evidence concerning current treatment interventions for fractures of the distal femur. The currently available evidence is incomplete and insufficient to inform current clinical practice. Priority should be given to a definitive, pragmatic, multicentre randomised controlled clinical trial comparing contemporary treatments such as locked plates and intramedullary nails. At minimum, these should report validated patient-reported functional and quality-of-life outcomes at one and two years. All trials should be reported in full using the CONSORT guidelines.


Assuntos
Fraturas do Fêmur/terapia , Fixação de Fratura/métodos , Adulto , Idoso , Feminino , Fixação de Fratura/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Tração/métodos
16.
Cochrane Database Syst Rev ; (6): CD008579, 2014 Jun 23.
Artigo em Inglês | MEDLINE | ID: mdl-24956457

RESUMO

BACKGROUND: The morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a person's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture. This is an update of a review previously published in February 2012. OBJECTIVES: To assess the effects of low-intensity ultrasound (LIPUS), high-intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (2 June 2014), the Cochrane Central Register of Controlled Trials (The Cochrane Library 2014, Issue 5), MEDLINE (1946 to May Week 3 2014), EMBASE (1980 to 2014 Week 22), trial registers and reference lists of articles. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials evaluating ultrasound treatment in the management of acute fractures in adults. Studies had to include participants over 18 years of age with acute fractures, reporting outcomes such as function; time to union; non-union; secondary procedures such as for fixation or delayed union or non-union; adverse effects; pain; costs; and patient adherence. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from the included studies. Treatment effects were assessed using mean differences, standardised mean differences or risk ratios using a fixed-effect model, except where there was substantial heterogeneity, when data were pooled using a random-effects model. Results from 'worst case' analyses, which gave more conservative estimates of treatment effects for time to fracture union, are reported in preference to those from 'as reported' analyses. MAIN RESULTS: We included 12 studies, involving 622 participants with 648 fractures. Eight studies were randomised placebo-controlled trials, two were randomised controlled trials without placebo controls, one was a quasi-randomised placebo-controlled trial and one was a quasi-randomised controlled trial without placebo control. Eleven trials tested LIPUS and one trial tested ECSW. Four trials included participants with conservatively treated upper limb complete fractures and six trials included participants with lower limb complete fractures; these were surgically fixed in four trials. The remaining two trials reported results for conservatively treated tibial stress fractures.'Risk of bias' assessment of the included studies was hampered by the poor reporting of methods, frequently resulting in the risk of bias of individual domains being judged as 'unclear'. Both quasi-randomised studies were at high risk of bias, including selection and attrition bias. Three studies were at low risk of selection bias relating to allocation concealment the majority of studies were at low risk of performance bias as they employed a form of intervention blinding.Only limited data were available from three of only four studies reporting on functional outcome. One study of complete fractures found little evidence of a difference between the two groups in the time to return to work (mean difference (MD) 1.95 days favouring control, 95% confidence interval (CI) -2.18 to 6.08; 101 participants). Pooled data from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (MD -8.55 days, 95% CI -22.71 to 5.61; 93 participants).We adopted a conservative strategy for data analysis that was more likely to underestimate than to overestimate a benefit of the intervention. After pooling results from eight studies (446 fractures), the data showed no statistically significant reduction in time to union of complete fractures treated with LIPUS (standardised mean difference (SMD) -0.47, 95% CI -1.14 to 0.20). This result could include a clinically important benefit or harm, and should be seen in the context of the highly significant statistical heterogeneity (I² = 90%). This heterogeneity was not explained by the a priori subgroup analyses (upper limb versus lower limb fracture, smoking status). An additional subgroup analysis comparing conservatively and operatively treated fractures raised the possibility that LIPUS may be effective in reducing healing time in conservatively managed fractures, but the test for subgroup differences did not confirm a significant difference between the subgroups.Pooled results from five of the eight trials (333 fractures) reporting proportion of delayed union or non-union showed no significant difference between LIPUS and control (10/168 versus 13/165; RR 0.75; 95% CI 0.24 to 2.28). Adverse effects directly associated with LIPUS and associated devices were found to be few and minor, and compliance with treatment was generally good. One study reporting on pain scores found no difference between groups at eight weeks (101 participants).One quasi-randomised study found no significant difference in non-union at 12 months between internal fixation supplemented with ECSW and internal fixation alone (3/27 versus 6/30; RR 0.56, 95% CI 0.15 to 2.01). There was a clinically small but statistically significant difference in the visual analogue scores for pain in favour of ECSW at three month follow-up (MD -0.80, 95% CI -1.23 to -0.37). The only reported complication was infection, with no significant difference between the two groups. AUTHORS' CONCLUSIONS: While a potential benefit of ultrasound for the treatment of acute fractures in adults cannot be ruled out, the currently available evidence from a set of clinically heterogeneous trials is insufficient to support the routine use of this intervention in clinical practice. Future trials should record functional outcomes and follow-up all trial participants.


Assuntos
Consolidação da Fratura , Fraturas Ósseas/terapia , Terapia por Ultrassom/métodos , Adulto , Traumatismos do Braço/terapia , Fixação de Fratura/métodos , Fraturas de Estresse/terapia , Fraturas não Consolidadas , Humanos , Traumatismos da Perna/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Terapia por Ultrassom/efeitos adversos
17.
BMJ Open ; 3(6)2013 Jun 25.
Artigo em Inglês | MEDLINE | ID: mdl-23801709

RESUMO

OBJECTIVE: To quantify and draw inferences on the clinical effectiveness of platelet-rich therapy in the management of patients with a typical osteoporotic fracture of the hip. DESIGN: Single centre, parallel group, participant-blinded, randomised controlled trial. SETTING: UK Major Trauma Centre. PARTICIPANTS: 200 of 315 eligible patients aged 65 years and over with any type of intracapsular fracture of the proximal femur. Patients were excluded if their fracture precluded internal fixation. INTERVENTIONS: Participants underwent internal fixation of the fracture with cannulated screws and were randomly allocated to receive an injection of platelet-rich plasma into the fracture site or not. MAIN OUTCOME MEASURES: Failure of fixation within 12 months, defined as any revision surgery. RESULTS: Primary outcome data were available for 82 of 101 and 78 of 99 participants allocated to test and control groups, respectively; the remainder died prior to final follow-up. There was an absolute risk reduction of 5.6% (95% CI -10.6% to 21.8%) favouring treatment with platelet-rich therapy (χ(2) test, p=0.569). An adjusted effect estimate from a logistic regression model was similar (OR=0.71, 95% CI 0.36 to 1.40, z test; p=0.325). There were no significant differences in any of the secondary outcome measures excepting length of stay favouring treatment with platelet-rich therapy (median difference 8 days, Mann-Whitney U test; p=0.03). The number and distribution of adverse events were similar. Estimated cumulative incidence functions for the competing events of death and revision demonstrated no evidence of a significant treatment effect (HR 0.895, 95% CI 0.533 to 1.504; p=0.680 in favour of platelet-rich therapy). CONCLUSIONS: No evidence of a difference in the risk of revision surgery within 1 year in participants treated with platelet-rich therapy compared with those not treated. However, we cannot definitively exclude a clinically meaningful difference. TRIAL REGISTRATION: Current Controlled Trials, ISRCTN49197425, http://www.controlled-trials.com/ISRCTN49197425.

18.
Cochrane Database Syst Rev ; (7): CD009496, 2012 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-22786528

RESUMO

BACKGROUND: The morbidity and socioeconomic costs associated with long bone healing are considerable. Platelet-rich therapies are autologous blood products with a greater concentration of platelets than physiological whole blood. Despite promising results from a number of in-vitro animal studies, clinical evidence to support the use of platelet-rich therapy in long bone healing is unclear. OBJECTIVES: To assess the effects (benefits or harms) of platelet-rich therapies for treating long bone osteotomies, acute fractures, un-united fractures and defects in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (8 November 2011), the Cochrane Central Register of Controlled Trials (The Cochrane Library, 2011 Issue 4), MEDLINE (1948 to November Week 1 2011) and EMBASE (1980 to Week 44 2011). Trial registers and reference lists of articles were also searched. SELECTION CRITERIA: Randomised and quasi-randomised controlled clinical trials evaluating any type of platelet-rich therapy compared with either no additional treatment or a placebo in the management of long bone osteotomies, acute fractures, un-united fractures and defects in adults. Studies including participants over 18 years of age; reporting functional outcomes, time to union, non-union, secondary procedures such as for fixation failure or delayed or non-union, adverse effects, pain or costs were included. DATA COLLECTION AND ANALYSIS: Two authors independently selected the studies for inclusion in the review. Studies were assessed for the risk of bias using The Cochrane Collaboration's 'Risk of bias' tool. Treatment effects for dichotomous outcomes were expressed with risk ratios (RR) and continuous measures with mean differences, together with 95% confidence intervals (CI). MAIN RESULTS: Only one eligible study, involving 21 participants, was included. The study compared platelet-rich therapy and allogenic bone graft with allogenic bone graft alone in patients undergoing corrective osteotomy for medial compartment osteoarthrosis of the knee. The risk of bias associated with this study was substantial. There was no significant difference in patient-reported or clinician-assessed functional outcome scores between groups at one year. There was a statistically significant benefit from platelet-rich therapy in the proportion of bones that were united at one year (8/9 versus 3/9; RR 2.67; 95% CI 1.03 to 6.91). This benefit, however, was not maintained when assuming poor outcomes for participants who were lost to follow-up (8/11 versus 3/10; RR 2.42; 95% CI 0.88 to 6.68). One adverse event was reported in a participant receiving platelet-rich therapy.One other eligible study involving hip fracture patients is currently underway. AUTHORS' CONCLUSIONS: While a potential benefit of platelet-rich therapies to augment long bone healing in adults cannot be ruled out, the currently available evidence from a single trial is insufficient to support the routine use of this intervention in clinical practice. Future trials should focus on reporting patient-reported functional outcomes from all trial participants for a minimum follow-up of one year.


Assuntos
Transplante Ósseo/métodos , Consolidação da Fratura/fisiologia , Osteoartrite do Joelho/cirurgia , Osteotomia/métodos , Plasma Rico em Plaquetas , Adulto , Idoso , Humanos , Itália , Pessoa de Meia-Idade , Transplante Homólogo
19.
Cochrane Database Syst Rev ; (2): CD008579, 2012 Feb 15.
Artigo em Inglês | MEDLINE | ID: mdl-22336847

RESUMO

BACKGROUND: The morbidity and socioeconomic costs of fractures are considerable. The length of time to healing is an important factor in determining a patient's recovery after a fracture. Ultrasound may have a therapeutic role in reducing the time to union after fracture. OBJECTIVES: To assess the effects of low intensity ultrasound (LIPUS), high intensity focused ultrasound (HIFUS) and extracorporeal shockwave therapies (ECSW) as part of the treatment of acute fractures in adults. SEARCH METHODS: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (December 2011), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2011, Issue 4), MEDLINE (1950 to November Week 3 2011), EMBASE (1980 to 2011 Week 49), trial registers and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials evaluating ultrasound treatment in the management of acute fractures in adults. Studies including participants over 18 years of age with acute fractures, reporting functional outcomes, time to union, non-union, secondary procedures such as for fixation or delayed or non-union, adverse effects, pain, costs or patient adherence were included. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data from the included studies. Treatment effects were assessed using mean differences or risk ratios and, where there was substantial heterogeneity, pooled using a random-effects model. Results from 'worst case' analyses, which gave more conservative estimates of treatment effects for time to fracture union, are reported in preference to those from 'as reported' analyses. MAIN RESULTS: Twelve studies, involving 622 participants with 648 fractures, were included. Eight studies were randomised placebo-controlled trials, two studies were randomised controlled trials without placebo controls, one study was a quasi-randomised placebo controlled trial and the remaining study was a quasi-randomised controlled trial without placebo control. Eleven trials tested LIPUS and one trial tested ECSW. Four trials included participants with conservatively treated upper limb complete fractures and six trials included participants with lower limb complete fractures; these were surgically fixed in four trials. The remaining two trials reported results for conservatively treated tibial stress fractures.Very limited data from two complete fracture studies showed no difference between ultrasound and placebo control in functional outcome. Pooled estimates from two studies found LIPUS did not significantly affect the time to return to training or duty in soldiers or midshipmen with stress fractures (mean difference -8.55 days, 95% CI -22.71 to 5.61).Based on a 'worst case' analysis, which adjusted for incomplete data, pooled results from eight heterogeneous studies showed no statistically significant reduction in time to union of complete fractures treated with LIPUS (standardised mean difference -0.47, 95% CI -1.14 to 0.20). This result could include a clinically important benefit or harm, and should be seen in the context of the highly significant statistical heterogeneity (I² = 90%). This heterogeneity was not explained by the a priori subgroup analyses (upper limb versus lower limb fracture, smoking status). An additional subgroup analysis comparing conservatively and operatively treated fractures raised the possibility that LIPUS may be effective in reducing healing time in conservatively managed fractures, but the test for subgroup differences did not confirm a significant difference between the subgroups.Pooled results from eight trials reporting proportion of delayed union or non-union showed no significant difference between LIPUS and control. Adverse effects directly associated with LIPUS and associated devices were found to be few and minor, and compliance with treatment was generally good. One study reporting on pain scores found no difference between groups at eight weeks.One quasi-randomised study (59 fractures) found no significant difference between ECSW and no-placebo control groups in non-union at 12 months (risk ratio 0.56, 95% CI 0.15 to 2.01). There was a clinically small but statistically significant difference in the visual analogue scores for pain in favour of ECSW at three month follow-up. The only reported complication was infection, with no significant difference between the two groups. AUTHORS' CONCLUSIONS: While a potential benefit of ultrasound for the treatment of acute fractures in adults cannot be ruled out, the currently available evidence from a set of clinically heterogeneous trials is insufficient to support the routine use of this intervention in clinical practice. Future trials should record functional outcomes and follow-up all trial participants.


Assuntos
Consolidação da Fratura , Fraturas Ósseas/terapia , Terapia por Ultrassom/métodos , Adulto , Traumatismos do Braço/terapia , Fixação de Fratura/métodos , Fraturas de Estresse/terapia , Fraturas não Consolidadas , Humanos , Traumatismos da Perna/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Terapia por Ultrassom/efeitos adversos
20.
Cochrane Database Syst Rev ; (4): CD008471, 2011 Apr 13.
Artigo em Inglês | MEDLINE | ID: mdl-21491410

RESUMO

BACKGROUND: Delayed union and non-union of fractures are a considerable cause of morbidity to patients. Laboratory studies have shown that electromagnetic fields can stimulate the formation of new bone, indicating a potential role for electromagnetic stimulation in the treatment of fractures that have failed to heal. OBJECTIVES: To assess the effects of electromagnetic stimulation for treating delayed union or non-union of long bone fractures in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (May 2010), the Cochrane Central Register of Controlled Trials (in The Cochrane Library 2010, Issue 2), MEDLINE (1966 to May 2010) and EMBASE (1980 to 2010 Week 20), trial registers and reference lists of articles. SELECTION CRITERIA: Randomised controlled trials evaluating electromagnetic field stimulation for the treatment of delayed union or non-union of long bones in adults. DATA COLLECTION AND ANALYSIS: Two authors independently selected studies and performed data extraction and risk of bias assessment. Treatment effects were assessed using risk ratios and, where appropriate, data were pooled using a random-effects model. MAIN RESULTS: Four studies, involving 125 participants, were included. Three studies evaluated the effects of pulsed electromagnetic fields and one study, capacitive coupled electric fields. Participants with delayed union and non-union of the long bones were included, but most data related to non-union of the tibia. Although all studies were blinded randomised placebo-controlled trials, each study had limitations.The primary measure of the clinical effectiveness of electromagnetic field stimulation was the proportion of participants whose fractures had united at a fixed time point. The overall pooled effect size was small and not statistically significant (risk ratio 1.96; 95% confidence interval 0.86 to 4.48; 4 trials). There was substantial clinical and statistical heterogeneity in this pooled analysis (I(2) = 58%). A sensitivity analysis conducted to determine the effect of multiple follow-up time-points on the heterogeneity amongst the studies showed that the effect size remained non-significant at 24 weeks (risk ratio 1.61; 95% confidence interval 0.74 to 3.54; 3 trials), with similar heterogeneity (I(2) = 57%).There was no reduction in pain found in two trials. No study reported functional outcome measures. One trial reported two minor complications resulting from treatment. AUTHORS' CONCLUSIONS: Though the available evidence suggests that electromagnetic field stimulation may offer some benefit in the treatment of delayed union and non-union of long bone fractures, it is inconclusive and insufficient to inform current practice. More definitive conclusions on treatment effect await further well-conducted randomised controlled trials.


Assuntos
Traumatismos do Braço/terapia , Consolidação da Fratura , Fraturas não Consolidadas/terapia , Traumatismos da Perna/terapia , Terapia de Campo Magnético/métodos , Adulto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fraturas da Tíbia/terapia
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