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BACKGROUND: Arthroplasty registries are rarely used to inform encounters between clinician and patient. This study is part of a larger one which aimed to develop an information tool allowing both to benefit from previous patients' experience after total hip arthroplasty (THA). This study focuses on generating the information tool specifically for pain outcomes. METHODS: Data from the Geneva Arthroplasty Registry (GAR) about patients receiving a primary elective THA between 1996 and 2019 was used. Selected outcomes were identified from patient and surgeon surveys: pain walking, climbing stairs, night pain, pain interference, and pain medication. Clusters of patients with homogeneous outcomes at 1, 5, and 10 years postoperatively were generated based on selected predictors evaluated preoperatively using conditional inference trees (CITs). RESULTS: Data from 6,836 THAs were analysed and 14 CITs generated with 17 predictors found significant (p < 0.05). Baseline WOMAC pain score, SF-12 self-rated health (SRH), number of comorbidities, SF-12 mental component score, and body mass index (BMI) were the most common predictors. Outcome levels varied markedly by clusters whilst predictors changed at different time points for the same outcome. For example, 79% of patients with good to excellent SRH and less than moderate preoperative night pain reported absence of night pain at 1 year after THA; in contrast, for those with fair/poor SHR this figure was 50%. Also, clusters of patients with homogeneous levels of night pain at 1 year were generated based on SRH, Charnley, WOMAC night and pain scores, whilst those at 10 years were based on BMI alone. CONCLUSIONS: The information tool generated under this study can provide prospective patients and clinicians with valuable and understandable information about the experiences of "patients like them" regarding their pain outcomes.
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Artroplastia de Reemplazo de Cadera , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Resultado del Tratamiento , Estudios Prospectivos , Datos de Salud Recolectados Rutinariamente , Dolor/etiologíaRESUMEN
BACKGROUND AND PURPOSE: We aimed to evaluate the long-term predictive value of radiographic abnormality and/or hip pain assessed 5 years following primary total hip arthroplasty (THA) and the occurrence of revision for aseptic loosening between 5 and 25 years postoperatively. PATIENTS AND METHODS: We included all primary THAs performed between 1996 and 2011 (same uncemented cup, polyethylene-ceramic bearing, 28 mm head, cemented stem) and prospectively enrolled in the institutional registry, for whom baseline and follow-up radiographs were available. At 5 years radiographically we assessed femoral osteolysis and/or stem migration. Pain was evaluated with the Harris Hip pain subscore. Kaplan-Meier survival and Cox regression analyses were performed. RESULTS: 1,317 primary THAs were included. 25 THAs (2%) were revised for aseptic stem loosening. Any abnormal radiographic sign at 5 years was present in 191 THAs (14%). Occasional hip pain was reported by 20% and slight to severe pain by 12% of patients at 5 years. In patients < 60 years, 10 of the 12 later revised for aseptic stem loosening had abnormal radiographs at 5 years vs. 5 of the 13 later revised in those ≥ 60 years. Hazard ratios (HR) were 34 (95% confidence interval [CI] 7-155) in younger vs. 4 (CI 1-11) in the older group. HR for association of hip pain at 5 years with future revision was 3 (CI 1-5). CONCLUSION: The presence of abnormal radiographic signs 5 years after THA was strongly associated with later revision for aseptic stem loosening, especially in patients < 60 years. The association between pain at 5 years and future revision was much weaker.
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Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Prótesis de Cadera/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento , Falla de Prótesis , Reoperación , Cementos para Huesos , Dolor , Artralgia , Polietileno , Diseño de Prótesis , Estudios de SeguimientoRESUMEN
BACKGROUND AND PURPOSE: Younger recipients of total hip arthroplasty (THA) highly prioritize returning to preoperative levels of physical activity (PA). Surgeons have tended to give cautious advice concerning high-impact sports participation, but there have been few long-term studies. The purpose of our study was to investigate the risk of revision arthroplasty in relation to postoperative PA levels. METHODS: Patients registered in the Geneva Arthroplasty Register (GAR) who had elective THA when they were aged < 65 years were studied. Postoperative PA was collected prospectively 5-yearly using the UCLA activity scale. Cox proportional hazards models were used to estimate associations between PA and risk of revision THA. RESULTS: Amongst 1,370 eligible subjects, median age at THA 58 years (interquartile range 51-61), UCLA scores were available for 973 (71%). During follow-up over 15 years, there were 79 revisions, giving a cumulative risk of 7.4% (95% confidence interval [CI] 5.8-9.4). After adjusting for covariates, we found an increased risk of revision for each unit increase in postoperative PA (HR 1.2, CI 1.1-1.4), and among people performing the most intensive PA (HR 2.7, CI 1.3-5.6) compared with those who were inactive. CONCLUSION: The overall risk of revision was small but intensive and moderate PA may be associated with an increased risk of revision.
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Artroplastia de Reemplazo de Cadera , Ejercicio Físico , Sistema de Registros , Reoperación , Humanos , Artroplastia de Reemplazo de Cadera/efectos adversos , Persona de Mediana Edad , Masculino , Reoperación/estadística & datos numéricos , Femenino , Ejercicio Físico/fisiología , Factores de Riesgo , Estudios de Cohortes , Suiza/epidemiología , Estudios de Seguimiento , Modelos de Riesgos Proporcionales , Estudios ProspectivosRESUMEN
BACKGROUND: Ankle fractures are a common injury and the main cause of post-traumatic ankle arthritis. The prevalence of obesity is increasing worldwide, and this population is known to have poorer short and midterm outcomes after ankle fractures. Our objective is to assess long-term patient-reported outcomes in patients with operatively treated ankle fractures, and the effect of BMI on these results using the new and validated patient-reported outcome questionnaire, the Manchester Oxford foot and ankle questionnaire (MOXFQ). METHODS: We performed a retrospective review of all ankle fractures treated operatively in a ten-year period from 2002-2012. The MOXFQ and SF-12 were sent to all patients and were obtained, on average, 11.1 years after surgery (range 5.3-16.2 years). RESULTS: Two thousand fifty-five ankle fractures were reviewed, of which 478 (34%) patients completed the questionnaires. The mean age was 48.1 ± 15.5 years, 52% were men and the mean BMI was 26.1 ± 4.5 kg/m2. Of the 478, 47% were of normal weight, 36% were overweight, and 17% were obese. Overall, 2.1% were type A, 69.9% B, and 24.9% type C fractures. There were no significant differences in the type of fracture between the BMI groups. Comparing obese and non-obese patients, there were large differences in MOXFQ pain (33 ± 29 vs. 18.7 ± 22.1, effect size 0.55), and function scores (27.3 ± 29 vs. 12.5 ± 21.1, effect size 0.58). No differences in complications and reoperations rates were observed. The BMI value at surgery correlated more strongly with the MOXFQ pain score than the BMI at follow-up (Spearman's Rho 0.283 vs. 0.185, respectively). CONCLUSION: These findings reveal that obese patients have significant worse long-term outcomes, namely increased pain, poorer function, and greater impairment in everyday life after an operatively treated ankle fracture. Moreover, pain and function linearly declined with increasing BMI. Our findings appear to indicate that increased BMI at surgery is an important contributor to adverse outcome in the operative management of rotational ankle fractures. LEVEL OF EVIDENCE: III.
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Fracturas de Tobillo , Adulto , Tobillo , Fracturas de Tobillo/diagnóstico por imagen , Fracturas de Tobillo/epidemiología , Fracturas de Tobillo/cirugía , Articulación del Tobillo/cirugía , Índice de Masa Corporal , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana EdadRESUMEN
BACKGROUND: Objectives were first to evaluate by education level one-year trajectories of pain, function and general health, as well as hospital resource and medication needs in patients undergoing primary total hip arthroplasty (THA); and second, to evaluate whether outcome differences are related to existing baseline differences in health and disease severity. METHODS: We included all primary THAs from a public hospital-based prospective arthroplasty registry, performed in a high-income country 2010 to 2017. Education was classified in three levels: ≤8years of schooling (low), 9-12years (medium), and ≥13years (high). Pain and function prior to and one-year after surgery were assessed with the Western Ontario McMaster Universities score (WOMAC) and general health with the 12-item short-form health survey (SF-12). RESULTS: Overall 963 patients were included, 340 (35.3%) with low, 306 (31.8%) with medium, and 317 (32.9%) with high education. With increasing educational level preoperative scores for pain, function and SF-12 mental health component increased. One year after surgery improvement was observed in all education categories for WOMAC pain and function, SF-12 mental and physical component. However, absolute postoperative scores remained lower in all four domains for the low education group. After adjustment for baseline characteristics differences were much attenuated and no longer significant. There was also greater resource need in low educated patients. CONCLUSIONS: The inferior absolute results one year after surgery in less educated patients were largely due to older age, worse preoperative health and greater symptom severity calling for greater attention to timely and equal management, for more targeted perioperative care and increased support for the lower education group.
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Artroplastia de Reemplazo de Cadera , Anciano , Artroplastia de Reemplazo de Cadera/efectos adversos , Humanos , Medición de Resultados Informados por el Paciente , Periodo Posoperatorio , Estudios Prospectivos , Resultado del TratamientoRESUMEN
BACKGROUND AND PURPOSE: The influence of postoperative limping on patient satisfaction and amount of limping reduction following THA are not well documented. We (1) assessed if postoperative limping is associated with satisfaction 5 years after THA performed via the lateral or anterior approach; (2) evaluated the influence of surgical approach on amount of limping reduction following THA. PATIENTS AND METHODS: We conducted a prospective cohort study of primary elective THAs performed in 2002-2013. Limping was assessed before and 5 years after surgery using the Harris Hip limping sub-score. Satisfaction was assessed at 5 years on a 5-point Likert scale. We compared proportions of satisfied patients among groups of limping. Evolution of limping before and after surgery was noted. Analyses were performed overall and stratified by pain and surgical approach. We used univariate and multivariate logbinomial regression models. RESULTS: 1,257 patients were included (mean age 70 years). 81% had surgery via a lateral and 19% via an anterior approach. Before THA, 60% had moderate to severe limping and all reported pain. After THA, limping and pain improved; 9% of patients were dissatisfied. In multivariate analysis stratified on pain level, limping was associated with higher dissatisfaction. Similar results were obtained after lateral vs. anterior approach. INTERPRETATION: Postoperative limping impacts patient satisfaction after THA. The association varied by degree of limping and absence or presence of pain. It was independent of surgical approach. 5 years after THA occurrence of limping was largely reduced after both a lateral and an anterior approach, with low evidence of a greater reduction under an anterior approach.
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Artroplastia de Reemplazo de Cadera , Anciano , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/métodos , Estudios de Cohortes , Humanos , Dolor , Satisfacción del Paciente , Estudios Prospectivos , Sistema de Registros , Resultado del TratamientoRESUMEN
BACKGROUND: Ankle fractures are common, and their incidence has been increasing. Previous epidemiological studies have been conducted in the US, Scandinavia, and Scotland. Our objectives were to provide a current epidemiological overview of operatively treated ankle fractures and to evaluate the influence of age, sex, lifestyle factors, and comorbidities on fracture types. METHODS: We performed a population-based epidemiological study of all ankle fractures treated operatively in a 10- year period from 2002 to 2012. RESULTS: Two thousand forty-five ankle fractures were operated upon. Men and women differed significantly in age (median 41 vs. 57 years old), obesity (16% vs. 23%), diabetes (5% vs. 10%), smoking (45% vs. 24%), and accident type (daily activities 48% vs. 79%, transportation 24% vs. 9%, sports 21% vs. 8%) respectively. Overall, there were 2% Weber A, 77% Weber B, and 21% Weber C fractures; 54% were uni-, 25% bi-, and 21% trimalleolar; 7.5% of all fractures were open. Weber C fractures were much more frequent among men and with higher BMI (lowest vs. highest category: 14% vs. 32%), but slightly less frequent with older age and among current smokers. Trimalleolar fractures were twice as frequent in women and increased with age. CONCLUSION: Men and women differed substantially in age, lifestyle factors, comorbidities, accident type, and type of ankle fracture. Male sex and higher BMI were more frequently associated with Weber C fractures, whereas female sex and older age were associated with trimalleolar fracture. The risk for severe fracture increased linearly with the degree of obesity.
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Fracturas de Tobillo , Anciano , Fracturas de Tobillo/diagnóstico por imagen , Fracturas de Tobillo/epidemiología , Fracturas de Tobillo/cirugía , Articulación del Tobillo , Femenino , Fijación Interna de Fracturas , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Países Escandinavos y Nórdicos , Escocia , SuizaRESUMEN
PURPOSE: Short stems use has increased substantially despite variable results reported in the literature. The purpose of this study was to report the rate of complications using a short stem implanted through the direct anterior approach (DAA), and to evaluate mid-term clinical and radiological results focusing on femoral stem fixation. METHODS: Between April 2009 and November 2014, 698 elective total hip arthroplasties (THAs) were performed using a fully hydroxyapatite-coated short stem (AMIStem-H®). The mean age was 65.7 years (SD 12.6). Patients were invited for clinical and radiological evaluation, and to complete patient-reported outcomes questionnaires at two and five years after surgery. The mean follow-up was 6.2 years (range 2-9.73 years). RESULTS: During the study period, 59 (8.5%) patients died and 24 (3.4%) were lost to follow-up. There were six (0.9%) dislocations and 12 (1.7%) fractures, seven occurred intra-operatively. Twenty-nine (4.2%) THAs required revision surgery. Eleven THAs were revised for aseptic loosening of the stem at a mean 4.9 years (1.2-7.3 years). Five years after surgery, radiographs of 324 THAs (324/425 eligible = 76.2%) were available. Stem subsidence ≥ 2 mm was present in 42 cases (12.9%), proximal radiolucencies in 101 hips (31.5%), cortical thickening in 52 (16.0%), and a pedestal in 219 (67.6%). An Engh score between - 10 and 0 was associated with lower HHS pain subscore (p = 0.005), a higher risk of stem revision for aseptic loosening (18.8% vs. 2.7%; p = 0.008), and was more frequent in younger patients with ASA score 1. CONCLUSION: Patients presenting radiological alterations at five years had an increased risk of revision for aseptic stem loosening and also inferior clinical results. Our study warrants further continued scrutiny of mid- and long-term survivorship of the AMIStem-H®, with radiological results at five years indicating suboptimal fixation of the stem in younger and active patients.
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Artroplastia de Reemplazo de Cadera , Hepatitis C Crónica , Prótesis de Cadera , Anciano , Artroplastia de Reemplazo de Cadera/efectos adversos , Estudios de Seguimiento , Prótesis de Cadera/efectos adversos , Humanos , Diseño de Prótesis , Falla de Prótesis , Reoperación , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
Background and purpose - Prior to primary total knee arthroplasty (pTKA), 6-34% of patients have undergone surgical procedure(s) of their knee. We investigated whether history of previous surgeries influences the risk of revision of pTKA, the risk according to the type of previous surgery, and how previous surgery influences specific causes of revision and the time of revision.Patients and methods - This is a prospective cohort study from the Geneva Arthroplasty Registry. All pTKA between 2000 and 2016 were included and followed until December 31, 2019. Outcomes were risk of revision, evaluated using Kaplan-Meier survival and Cox and competing risks regression, the specific causes, and time of revision.Results - Of 3,945 pTKA included (mean age 71 years, 68% women), 21% had a history of previous surgery, with 8.3% revisions vs. 4.3%, at 3-20 years' follow-up (mean 8.6). 5- and 10-year cumulative failure by previous surgery (yes vs. no) were 6.6% (95% CI 5.1-8.5) vs. 3.3% (CI 2.7-4.0), and 8.4% (CI 6.6-10.6) vs. 4.5% (CI 3.8-5.4). Baseline differences explained only part of the higher risk (adjusted HR 1.5, CI 1.1-2.1). The risk of failure was higher for all causes of revision considered. Patients in the previous surgery group had a higher risk of an early revision.Interpretation - A history of previous surgery adversely affected the outcome with a 1.5 times higher cumulative risk of all-cause revision over the course of up to 20 years after index surgery. The increased risk was seen for all causes of revision and was highest in the first years.
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Artroplastia de Reemplazo de Rodilla/métodos , Reoperación/estadística & datos numéricos , Anciano , Estudios de Cohortes , Femenino , Humanos , Masculino , Estudios Prospectivos , Sistema de Registros , Factores de RiesgoRESUMEN
Since 1996, the Geneva Arthroplasty Registry at the University Hospitals of Geneva (HUG) has been collecting, archiving and disseminating relevant high-quality information on primary total hip and knee arthroplasties and revision procedures performed at the Division of Orthopaedics and Traumatology. Patients are followed throughout their lifetime with the prosthesis. The registry has been essential to better understand and subsequently improve the care of patients with hip and knee replacements. It will continue to fulfil its mission and to work towards an even more effective transfer of the knowledge obtained to all stakeholders and as well as towards its implementation.
Depuis 1996, le registre genevois des arthroplasties aux HUG recueille, archive et diffuse des informations pertinentes de haute qualité concernant les arthroplasties primaires de la hanche et du genou ainsi que les procédures de révision réalisées au Service de chirurgie orthopédique et traumatologie de l'appareil moteur. Les patients sont suivis pendant toute leur vie avec la prothèse. Le registre a été essentiel pour mieux comprendre et ensuite améliorer la prise en charge de patients avec arthroplastie de hanche et de genou. Il continuera à remplir sa mission et à assurer une transmission encore plus efficace des connaissances obtenues vers tous les groupes concernés (stakeholders) et à leur implémentation.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Humanos , Sistema de Registros , ReoperaciónRESUMEN
BACKGROUND: Mental health has been shown to improve after total hip arthroplasty (THA). Little is known about the role of pain and function in this context. We assessed whether change in mental health was associated with improvement in pain and function 1 year post-surgery. METHODS: This prospective study included patients enrolled in a THA registry from 2010 to 2014. We examined the mental component score (MCS) before and 1 year post-surgery, and 1-year change, in association with Western Ontario McMaster Universities (WOMAC) pain and function scores. All scores were normalized, ranging from 0 to 100 (larger score indicating better outcome). Analyses were adjusted for potential confounders. RESULTS: Our study included 610 participants, of which 53% were women. Descriptive statistics are as follows: the average (SD) for age (years) was 68.5 (11.8), and for BMI was 26.9 (4.9). In addition, the MCS average (SD) at baseline was 44.7 (11.2), and at 1-year after THA was 47.5 (10.5). The average change from baseline to 1-year post-THA in MCS was 2.8 (95% CI: 1.9, 3.6), for an effect size of 0.26. As for the WOMAC pain score, the average change from baseline to 1-year post-THA was 44.2 (95%CI: 42.4, 46.0), for an effect size of 2.5. The equivalent change in WOMAC function was 38.1 (95% CI: 36.2, 40.0), for an effect size of 2.0. Results from multivariable analysis controlling for covariates showed that an improvement of 10 points in the 1-year change in pain score resulted in a 0.78 point (95%: CI 0.40, 1.26) increase in the 1-year change in MCS, whereas a 10-point improvement in the 1-year change in function was associated with a 0.94 point (95% CI: 0.56, 1.32) increase. CONCLUSIONS: Mental health significantly improved from baseline to 1-year post-THA. Greater improvement in pain and function was associated with greater improvement in mental health 1 year post-THA.
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Artralgia/cirugía , Artroplastia de Reemplazo de Cadera , Salud Mental , Osteoartritis de la Cadera/cirugía , Anciano , Artralgia/diagnóstico , Artralgia/psicología , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Osteoartritis de la Cadera/diagnóstico , Osteoartritis de la Cadera/psicología , Dimensión del Dolor , Periodo Posoperatorio , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Índice de Severidad de la Enfermedad , Encuestas y Cuestionarios , Resultado del TratamientoRESUMEN
PURPOSE: This study was conducted to characterise the O-arm® surgical imaging system in terms of patient organ doses and medical staff occupational exposure during three-dimensional thoracic spine and pelvic examinations. METHODS: An anthropomorphic phantom was used to evaluate absorbed organ doses during a three-dimensional thoracic spine scan and a three-dimensional pelvic scan with the O-arm®. Staff occupational exposure was evaluated by constructing an ambient dose cartography of the operating theatre during a three-dimensional pelvic scan as well as using an anthropomorphic phantom to simulate the O-arm® operator. RESULTS: Patient organ doses ranged from 30 ± 4 µGy to 20.0 ± 3.0 mGy and 4 ± 1 µGy to 6.7 ± 1.0 mGy for a three-dimensional thoracic spine and pelvic examination, respectively. For a single three-dimensional acquisition, the maximum ambient equivalent dose at 2 m from the iso-centre was 11 ± 1 µSv. CONCLUSION: Doses delivered to the patient during a three-dimensional thoracic spine image acquisition were found to be significant with the O-arm®, but lower than those observed with a standard computed tomography examination. The detailed dose cartography allows for the optimisation of medical staff positioning within the operating theatre while imaging with the O-arm®.
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Fluoroscopía/instrumentación , Exposición Profesional , Dosis de Radiación , Exposición a la Radiación , Humanos , Imagenología Tridimensional/instrumentación , Fantasmas de Imagen , Cirugía Asistida por ComputadorRESUMEN
BACKGROUND: The serious adverse events associated with metal on metal hip replacements have highlighted the importance of improving methods for monitoring surgical implants. The new European Union (EU) device regulation will enforce post-marketing surveillance based on registries among other surveillance tools. Europe has a common regulatory environment, a common market for medical devices, and extensive experience with joint replacement registries. In this context, we elaborate how joint replacement registries, while building on existing structure and data, can better ensure safety and balance risks and benefits. MAIN TEXT: Actions to improve registry-based implant surveillance include: enriching baseline and diversifying outcomes data collection; improving methodology to limit bias; speeding-up failure detection by active real-time monitoring; implementing risk-benefit analysis; coordinating collaboration between registries; and translating knowledge gained from the data into clinical decision-making and public health policy. CONCLUSIONS: The changes proposed here will improve patient safety, enforce the application of the new legal EU requirements, augment evidence, improve clinical decision-making, facilitate value-based health-care delivery, and provide up-to-date guidance for public health.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Sistema de Registros , Humanos , Prótesis Articulares de Metal sobre MetalRESUMEN
Background and purpose - The number of shoulder registries increases. We assessed international trends in use of shoulder arthroplasty, and described the current state of procedure selection and outcome presentation as documented in national and regional joint registries. Methods - Published reports from 9 population-based shoulder arthroplasty registries (country/region: Norway, Sweden, New Zealand, Denmark, California, Australia, Emilia-Romagna, Germany, and United Kingdom) were analyzed. Data were extracted on age, sex, disease indication, type of surgical procedure, surgical volume, and outcomes. Results - Shoulder arthroplasty incidence rate in 2012 was 20 procedures/105 population with a 6-fold variation between the highest (Germany) and lowest (United Kingdom) country. The annual incidence rate increased 2.8-fold in the past decade. Within the indications osteoarthritis, fracture, and cuff-tear arthropathy variations in procedure choice between registries were large. Outcomes evaluation focused on revision in all registries, but different measures and strata were used. Only Australia provided revision rates for prosthesis brands stratified by both indication and procedure. Finally, in 2 registries with available data surgeons performed on average 10-11 procedures yearly. Interpretation - Annual incidence rates of shoulder arthroplasty have almost tripled over the past decade. There is wide variation in procedure selection for the major indications, a low average surgeon volume, a substantial number of brands with small annual volume, and large variation in outcome presentation. The internationally increasing registry activity is an excellent basis for improving the so far weak evidence in shoulder arthroplasty.
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Artroplastía de Reemplazo de Hombro/estadística & datos numéricos , Osteoartritis/epidemiología , Sistema de Registros , Articulación del Hombro , Anciano , Conjuntos de Datos como Asunto , Femenino , Salud Global , Humanos , Incidencia , Masculino , Osteoartritis/cirugía , Estudios RetrospectivosRESUMEN
BACKGROUND: Use of surgical safety checklists has been associated with significant reduction in postoperative surgical site infection (SSI), morbidity, and mortality. OBJECTIVE: To evaluate the effectiveness of an intraoperative checklist in high-risk surgical patients in a high standard care environment with long-standing regular perioperative safety control programs. RESEARCH DESIGN: Quasi-experiment pre-post checklist implementation. SUBJECTS: Surgical patients above 16 years with an American Society of Anesthesiologists (ASA) score 3-5 operated upon at a large tertiary hospital. MEASURES: Unplanned return to operating room for any reason, reoperation for SSI, unplanned admission to intensive care unit, and in-hospital death within 30 days. RESULTS: A total of 609 patients (53% elective, 85% ASA 3, mean age 70 y) were included before and 1818 after implementation (52% elective, 87% ASA 3, mean age 69 y), the latter with 552, 558, and 708 in period I, II, and III, respectively. Comparing preimplementation to postimplementation periods: unplanned return to operating room occurred in 45/609 (7.4%) versus 109/1818 (6.0%) interventions [adjusted risk ratios (RR) 0.82; 95% confidence interval (CI), 0.59-1.14]; reoperation for SSI in 18/609 (3.0%) versus 109/1818 (1.7%) interventions (adjusted RR 0.56; 95% CI, 0.32-1.00); unplanned admission to intensive care unit in 17 (2.8%) versus 48 (2.6%) interventions (adjusted RR 0.90; 95% CI, 0.52-1.55); and in-hospital death occurred in 26 (4.3%) versus 108 (5.9%) patients (adjusted RR 1.44; 95% CI, 0.97-2.14). Checklist use during 77 interventions prevented 1 reoperation for SSI. CONCLUSIONS: A trend toward reduced reoperation rates for SSI was observed after checklist implementation in this high standard care environment; no influence on other outcome measures was observed.
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Lista de Verificación , Seguridad del Paciente , Reoperación/estadística & datos numéricos , Procedimientos Quirúrgicos Operativos/normas , Anciano , Femenino , Investigación sobre Servicios de Salud , Mortalidad Hospitalaria , Humanos , Masculino , Evaluación de Procesos y Resultados en Atención de Salud , Puntaje de Propensión , Mejoramiento de la Calidad , Factores de Riesgo , Infección de la Herida Quirúrgica/epidemiología , Infección de la Herida Quirúrgica/prevención & control , Infección de la Herida Quirúrgica/cirugíaRESUMEN
Purpose: The objective of this systematic review was to give an overview of clinical investigations regarding hip and knee arthroplasty implants published in peer-reviewed scientific medical journals before entry into force of the EU Medical Device Regulation in May 2021. Methods: We systematically reviewed the medical literature for a random selection of hip and knee implants to identify all peer-reviewed clinical investigations published within 10 years before and up to 20 years after regulatory approval. We report study characteristics, methodologies, outcomes, measures to prevent bias, and timing of clinical investigations of 30 current implants. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Results: We identified 2912 publications and finally included 151 papers published between 1995 and 2021 (63 on hip stems, 34 on hip cups, and 54 on knee systems). We identified no clinical studies published before Conformité Européene (CE)-marking for any selected device, and no studies even up to 20 years after CE-marking in one-quarter of devices. There were very few randomized controlled trials, and registry-based studies generally had larger sample sizes and better methodology. Conclusion: The peer-reviewed literature alone is insufficient as a source of clinical investigations of these high-risk devices intended for life-long use. A more systematic, efficient, and faster way to evaluate safety and performance is necessary. Using a phased introduction approach, nesting comparative studies of observational and experimental design in existing registries, increasing the use of benefit measures, and accelerating surrogate outcomes research will help to minimize risks and maximize benefits.
RESUMEN
We evaluated all revisions performed from March 1996 to December 2008 and compared complications, mortality, and clinical outcomes between patients 80 years and older and patients younger than 80 years. Data were collected prospectively. There were 325 revisions, 84 (25.8%) in patients 80 years and older and 241 in patients younger than 80 years (62% revision for aseptic loosening in both groups). The mean follow-up was 4.3 years. The results, 80 years and older vs younger than 80 years, revealed the following: mortality, 5% vs 0% 3 months postoperatively; medical complications in 23.8% vs 6.2%; postoperative fractures, 9.5% vs 2.5%; and improved Merle d'Aubigné scores from 9.6 to 13.0 vs 10.4 to 14.3. Revision total hip arthroplasty in patients 80 years and older was associated with substantial clinical improvement and patient satisfaction. However, medical complications and 90-day mortality were higher, and postoperative fractures occurred more frequently.
Asunto(s)
Artroplastia de Reemplazo de Cadera/mortalidad , Prótesis de Cadera , Fracturas Periprotésicas/epidemiología , Complicaciones Posoperatorias/epidemiología , Falla de Prótesis , Factores de Edad , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Prevalencia , Estudios Prospectivos , Reoperación , Estudios Retrospectivos , Tasa de Supervivencia , Resultado del TratamientoRESUMEN
Total hip arthroplasty (THA) with well designed cementless acetabular implants has shown excellent results. The purpose of this study was to assess our clinical and radiological outcomes using an uncemented cup. We conducted a prospective cohort study including all consecutive primary THAs performed with the Morscher press-fit cup, an uncemented non-modular acetabular component, between March 1996 and December 1998. Patients were evaluated at ten years with clinical and radiological follow-up, patient satisfaction and questionnaire assessment using the Harris hip score (HHS), Merle d'Aubigné and Postel score, the UCLA score, the 12-item short-form health survey (SF-12) and a visual analog scale. Five hundred sixty-one THAs were performed in 518 patients. At 120 months (± 7.3 months), 303 patients with 335 THAs were still available for follow-up. None of the patients had required cup revision for aseptic loosening. At ten years, the cup survivorship was 98.8% (95% CI 97.4-99.5) with cup revision for any cause as an endpoint. No radiolucencies were seen around the cups, but osteolytic defects involved 21 stems (8.3%). Mean total linear polyethylene wear was 0.9 mm. The Morscher acetabular replacement cup provides excellent results at ten years. There were no revisions for aseptic loosening of the cup, and no osteolytic defects were found around the cup. Patient satisfaction was high and the clinical results were very good.
Asunto(s)
Artroplastia de Reemplazo de Cadera/instrumentación , Prótesis de Cadera , Acetábulo/diagnóstico por imagen , Acetábulo/cirugía , Adulto , Anciano , Anciano de 80 o más Años , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Cadera/métodos , Cementación , Femenino , Estudios de Seguimiento , Estado de Salud , Articulación de la Cadera/diagnóstico por imagen , Articulación de la Cadera/fisiopatología , Articulación de la Cadera/cirugía , Humanos , Estimación de Kaplan-Meier , Masculino , Persona de Mediana Edad , Osteólisis/etiología , Satisfacción del Paciente , Complicaciones Posoperatorias , Estudios Prospectivos , Diseño de Prótesis , Radiografía , Resultado del Tratamiento , Adulto JovenRESUMEN
BACKGROUND: The effectiveness of the Latarjet largely depends on accurate graft placement, as well as on proper position and direction of the screws. We present our technique for an arthroscopically-assisted Latarjet comparing radiological results with the open technique. METHODS: We retrospectively reviewed the postoperative computed tomography scans of 38 patients who underwent a Latarjet procedure. For 16 patients, the procedure was performed with the open technique and, for 22 patients, it was performed using an arthroscopically-assisted technique. An independent radiologist evaluated graft and hardware position, as well as graft integration or resorption. Postoperative complications were also documented. RESULTS: The graft was correctly placed in only 18.8% of cases in the open group and 72.7% of cases in the arthroscopically-assisted group. There were no postoperative complications in the arthroscopically-assisted group, whereas one patient had a recurrence and two required hardware removal in the open group. CONCLUSIONS: The Latarjet procedure is a challenging procedure for which a key point is the correct placement of the coracoid graft onto the glenoid neck and correct position of the screws. The present study substantiates a clear benefit for the use of a guide with an arthroscopically-assisted technique in terms of graft and hardware placement. At short-term follow-up, there appears to be a benefit for graft integration and avoidance of resorption.
RESUMEN
Thus far the ability to predict who will develop early failure following the insertion of a metal-on-metal (MoM) bearing has been very limited. Our objective was to assess the effect of smoking on failure rates in patients with MoM bearing, compared with patients with ceramic-on-polyethylene (CoP) bearing. From a prospective hospital-based registry we included all primary THAs operated upon between 1/2001 and 12/2011 with MoM or CoP bearings of the same cup design and head size (28 mm). We compared revision rates through 10/2013 classified by smoking status and type of bearing. We included 1,964 patients (median age 71, 57% women), 663 with MoM and 1,301 with CoP bearing. Mean follow-up was 6.9 years (range 1.8-12.8). Revisions were required for 56 THAs. In patients with MoM bearing the adjusted incidence rate of revision among ever-smokers was four times greater than among never-smokers (95% CI 1.4-10.9). Among those with CoP bearing, the rate ratio was only 1.3 (95% CI 0.6-2.5). We found a strong association between smoking and increased failure of MoM THAs. In contrast, the association was weak for patients with CoP bearing. Smoking might be a trigger or an effect amplifier for adverse reactions to metal debris from MoM bearings.