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OBJECTIVES: This study aimed to ascertain the prevalence of cam femoroacetabular impingement syndrome (cam-FAIS) in anterior knee pain (AKP) patients devoid of both structural patellofemoral joint abnormalities and lower limb skeletal malalignment. A secondary objective was to examine pain and disability differences between AKP patients with and without cam-FAIS. METHODS: A total of 209 AKP patients were screened for eligibility. Inclusion criteria were normal imaging studies and normal lower limb alignment, and exclusion criteria were previous knee surgery and knee and/or hip osteoarthritis. Of those, 49 (23.4%) were eligible and this number matched a previous power analysis to detect statistically significant differences in prevalence of cam-FAIS in a population of AKP patients. The first step in the study sequence was to ask the patient whether they had groin pain. If so, the impingement test was done. Then, the femoral cam morphology defined by an alpha angle greater than or equal to 55° in a 45° Dunn axial view of the hip was ruled out. Additionally, patients completed Kujala and International Knee Documentation Committee (IKDC) functional knee scores for disability assessment. General population control group was obtained from literature. RESULTS: The study included 9 males and 40 females, with an average age of 36 (20-50, ±SD 8.03) years. Groin pain and positive impingement test were found in 26/49 patients (53%). An alpha angle ≥55° was observed in 35/49 patients (71%). A combination of groin pain, positive impingement test and an alpha angle ≥55° was seen in 18/49 patients (37%). The AKP patients with groin pain, a positive impingement test and an alpha angle ≥55° exhibited statistically similar pain and disability levels as AKP patients without cam-FAIS. CONCLUSION: The results of this study suggest that AKP patients without structural abnormalities in the patellofemoral joint and without lower limbs malalignment have a statistically significantly higher prevalence of cam-FAIS than the general population. Moreover, AKP patients with cam-FAIS have a statistically similar degree of pain and disability than AKP patients without it. STUDY DESIGN: Cross-sectional study. LEVEL OF EVIDENCE: IV.
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Pinzamiento Femoroacetabular , Articulación de la Rodilla , Humanos , Pinzamiento Femoroacetabular/epidemiología , Masculino , Femenino , Prevalencia , Adulto , Articulación de la Rodilla/cirugía , Persona de Mediana Edad , Adulto Joven , Artralgia/epidemiología , Dolor/epidemiología , Dimensión del DolorRESUMEN
Aims: To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture. Methods: This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty). Results: Eight female (29%) and 20 male trainees (71%), mean age 29.4 years, performed 317 DHS operations and 243 hemiarthroplasties during ten months of follow-up. Primary analysis was a random effect model with surgeon-level fixed effects of patient condition, patient age, and surgeon experience, with a random intercept for surgeon. Under the intention-to-treat principle, for hemiarthroplasty there was better implant position in favour of cadaveric training, measured by leg length discrepancy ≤ 10 mm (odds ratio (OR) 4.08 (95% confidence interval (CI) 1.17 to 14.22); p = 0.027). There were significantly fewer postoperative blood transfusions required in patients undergoing hemiarthroplasty by cadaveric-trained compared to standard-trained surgeons (OR 6.00 (95% CI 1.83 to 19.69); p = 0.003). For DHS, there was no significant between-group difference in implant position as measured by tip-apex distance ≤ 25 mm (OR 6.47 (95% CI 0.97 to 43.05); p = 0.053). No between-group differences were observed for any secondary clinical outcomes. Conclusion: Trainees randomized to additional cadaveric training performed hip fracture fixation with better implant positioning and fewer postoperative blood transfusions in hemiarthroplasty. This effect, which was previously unknown, may be a consequence of the intervention. Further study is required.
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Aims: Ankle fracture fixation is commonly performed by junior trainees. Simulation training using cadavers may shorten the learning curve and result in a technically superior surgical performance. Methods: We undertook a preliminary, pragmatic, single-blinded, multicentre, randomized controlled trial of cadaveric simulation versus standard training. Primary outcome was fracture reduction on postoperative radiographs. Results: Overall, 139 ankle fractures were fixed by 28 postgraduate year three to five trainee surgeons (mean age 29.4 years; 71% males) during ten months' follow-up. Under the intention-to-treat principle, a technically superior fixation was performed by the cadaveric-trained group compared to the standard-trained group, as measured on the first postoperative radiograph against predefined acceptability thresholds. The cadaveric-trained group used a lower intraoperative dose of radiation than the standard-trained group (mean difference 0.011 Gym2, 95% confidence interval 0.003 to 0.019; p = 0.009). There was no difference in procedure time. Conclusion: Trainees randomized to cadaveric training performed better ankle fracture fixations and irradiated patients less during surgery compared to standard-trained trainees. This effect, which was previously unknown, is likely to be a consequence of the intervention. Further study is required.
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BACKGROUND: Although randomized controlled trials comparing hip arthroscopy with physical therapy for the treatment of femoroacetabular impingement (FAI) syndrome have emerged, no studies have investigated potential moderators or mediators of change in hip-related quality of life. PURPOSE: To explore potential moderators, mediators, and prognostic indicators of the effect of hip arthroscopy and physical therapy on change in 33-item international Hip Outcome Tool (iHOT-33) score for FAI syndrome. STUDY DESIGN: Cohort study; Level of evidence, 2. METHODS: Overall, 99 participants were recruited from the clinics of orthopaedic surgeons and randomly allocated to treatment with hip arthroscopy or physical therapy. Change in iHOT-33 score from baseline to 12 months was the dependent outcome for analyses of moderators, mediators, and prognostic indicators. Variables investigated as potential moderators/prognostic indicators were demographic variables, symptom duration, alpha angle, lateral center-edge angle (LCEA), Hip Osteoarthritis MRI Scoring System (HOAMS) for selected magnetic resonance imaging (MRI) features, and delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) score. Potential mediators investigated were change in chosen bony morphology measures, HOAMS, and dGEMRIC score from baseline to 12 months. For hip arthroscopy, intraoperative procedures performed (femoral ostectomy ± acetabular ostectomy ± labral repair ± ligamentum teres debridement) and quality of surgery graded by a blinded surgical review panel were investigated for potential association with iHOT-33 change. For physical therapy, fidelity to the physical therapy program was investigated for potential association with iHOT-33 change. RESULTS: A total of 81 participants were included in the final moderator/prognostic indicator analysis and 85 participants in the final mediator analysis after exclusion of those with missing data. No significant moderators or mediators of change in iHOT-33 score from baseline to 12 months were identified. Patients with smaller baseline LCEA (ß = -0.82; P = .034), access to private health care (ß = 12.91; P = .013), and worse baseline iHOT-33 score (ß = -0.48; P < .001) had greater iHOT-33 improvement from baseline to 12 months, irrespective of treatment allocation, and thus were prognostic indicators of treatment response. Unsatisfactory treatment fidelity was associated with worse treatment response (ß = -24.27; P = .013) for physical therapy. The quality of surgery and procedures performed were not associated with iHOT-33 change for hip arthroscopy (P = .460-.665 and P = .096-.824, respectively). CONCLUSION: No moderators or mediators of change in hip-related quality of life were identified for treatment of FAI syndrome with hip arthroscopy or physical therapy in these exploratory analyses. Patients who accessed the Australian private health care system, had smaller LCEAs, and had worse baseline iHOT-33 scores, experienced greater iHOT-33 improvement, irrespective of treatment allocation.
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Pinzamiento Femoroacetabular , Osteoartritis de la Cadera , Humanos , Artroscopía/métodos , Australia , Estudios de Cohortes , Pinzamiento Femoroacetabular/cirugía , Pinzamiento Femoroacetabular/diagnóstico , Articulación de la Cadera/cirugía , Modalidades de Fisioterapia , Pronóstico , Calidad de Vida , Resultado del TratamientoRESUMEN
BACKGROUND: Bony morphology is central to the pathomechanism of femoroacetabular impingement syndrome (FAIS), however isolated radiographic measures poorly predict symptom onset and severity. More comprehensive morphology measurement considered together with patient factors may better predict symptom presentation. This study aimed to determine the morphological parameter(s) and patient factor(s) associated with symptom age of onset and severity in FAIS. METHODS: 99 participants (age 32.9 ± 10.5 years; body mass index (BMI 24.3 ± 3.1 kg/m2; 42% females) diagnosed with FAIS received standardised plain radiographs and magnetic resonance scans. Alpha angle in four radial planes (superior to anterior), acetabular version (AV), femoral torsion, lateral centre-edge, anterior centre-edge (ACEA) and femoral neck-shaft angles were measured. Age of symptom onset (age at presentation minus duration of symptoms), international Hip Outcome Tool-33 (iHOT-33) and modified UCLA activity scores were recorded. Backward stepwise regression assessed morphological parameters and patient factors (age, sex, BMI, symptom duration, annual income, private/public healthcare system accessed) to determine variables independently associated with onset age and iHOT-33 score. RESULTS: Earlier symptom onset was associated with larger superoanterior alpha angle (p = 0.007), smaller AV (p = 0.023), lower BMI (p = 0.010) and public healthcare system access (p = 0.041) (r2 = 0.320). Worse iHOT-33 score was associated with smaller ACEA (p = 0.034), female sex (p = 0.040), worse modified UCLA activity score (p = 0.010) and public healthcare system access (p < 0.001) (r2 = 0.340). CONCLUSIONS: Age of symptom onset was chiefly predicted by femoral and acetabular bony morphology measures, whereas symptom severity predominantly by patient factors. Factors measured explained a small amount of variance in the data; additional unmeasured factors may be more influential.
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Artroplastia de Reemplazo de Cadera , Pinzamiento Femoroacetabular , Humanos , Femenino , Adulto Joven , Adulto , Masculino , Pinzamiento Femoroacetabular/complicaciones , Edad de Inicio , Estudios Retrospectivos , Acetábulo/cirugía , Articulación de la Cadera/diagnóstico por imagen , Articulación de la Cadera/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Assessing the long term effects of many surgical interventions tested in pragmatic RCTs may require extended periods of participant follow-up to assess effectiveness and use patient-reported outcomes that require large sample sizes. Consequently the RCTs are often perceived as being expensive and time-consuming, particularly if the results show the test intervention is not effective. Adaptive, and particularly group sequential, designs have great potential to improve the efficiency and cost of testing new and existing surgical interventions. As a means to assess the potential utility of group sequential designs, we re-analyse data from a number of recent high-profile RCTs and assess whether using such a design would have caused the trial to stop early. METHODS: Many pragmatic RCTs monitor participants at a number of occasions (e.g. at 6, 12 and 24 months after surgery) during follow-up as a means to assess recovery and also to keep participants engaged with the trial process. Conventionally one of the outcomes is selected as the primary (final) outcome, for clinical reasons, with others designated as either early or late outcomes. In such settings, novel group sequential designs that use data from not only the final outcome but also from early outcomes at interim analyses can be used to inform stopping decisions. We describe data from seven recent surgical RCTs (WAT, DRAFFT, WOLLF, FASHION, CSAW, FIXDT, TOPKAT), and outline possible group sequential designs that could plausibly have been proposed at the design stage. We then simulate how these group sequential designs could have proceeded, by using the observed data and dates to replicate how information could have accumulated and decisions been made for each RCT. RESULTS: The results of the simulated group sequential designs showed that for two of the RCTs it was highly likely that they would have stopped for futility at interim analyses, potentially saving considerable time (15 and 23 months) and costs and avoiding patients being exposed to interventions that were either ineffective or no better than standard care. We discuss the characteristics of RCTs that are important in order to use the methodology we describe, particularly the value of early outcomes and the window of opportunity when early stopping decisions can be made and how it is related to the length of recruitment period and follow-up. CONCLUSIONS: The results for five of the RCTs tested showed that group sequential designs using early outcome data would have been feasible and likely to provide designs that were at least as efficient, and possibly more efficient, than the original fixed sample size designs. In general, the amount of information provided by the early outcomes was surprisingly large, due to the strength of correlations with the primary outcome. This suggests that the methods described here are likely to provide benefits more generally across the range of surgical trials and more widely in other application areas where trial designs, outcomes and follow-up patterns are structured and behave similarly.
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Inutilidad Médica , Registros , Recolección de Datos , Estudios de Factibilidad , Humanos , Tamaño de la MuestraRESUMEN
BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care. DESIGN: The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals. PARTICIPANTS: Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy. INTERVENTION: Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked. MAIN OUTCOME MEASURE: The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat. RESULTS: Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (N = 319; hip arthroscopy, n = 157; personalised hip therapy, n = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy (p = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years. LIMITATIONS: Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years. CONCLUSION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64081839. 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. 26, No. 16. See the NIHR Journals Library website for further project information.
In some people, the ball and the socket of the hip joint develop so that they do not fit together properly. This is called hip impingement, and is an important cause of hip and groin pain in young and middle-aged adults. Treatments include physiotherapy and surgery. Physiotherapy typically involves a programme of 610 outpatient consultations that aim to strengthen the muscles around the hip: we called this personalised hip therapy. Surgery can be carried out by a keyhole operation, called a hip arthroscopy, which aims to reshape the hip to prevent impingement. Surgery is normally followed by some physiotherapy. We performed a research study to compare the results of hip arthroscopy and personalised hip therapy in people with hip impingement. A total of 348 people with painful hip impingement in 23 hospitals in the UK agreed to take part. About half were treated with hip arthroscopy and half with personalised hip therapy. We used questionnaires to ask participants about pain in the hip and their ability to do everyday things at 6 months and 1 year after entering the study. At 2 and 3 years, we asked if patients required any additional treatments. We found that both groups improved, but those treated with hip arthroscopy improved a moderate amount more than those treated with personalised hip therapy. However, these improvements were not cost-effective compared with personalised hip therapy at 1 year. We need to see whether or not this difference continues after several years, but the results, so far, suggest that if a person has painful hip impingement, then hip arthroscopy offers greater improvements than personalised hip therapy.
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Pinzamiento Femoroacetabular , Adolescente , Artroscopía , Análisis Costo-Beneficio , Pinzamiento Femoroacetabular/cirugía , Humanos , Dolor , Calidad de Vida , Reino Unido , Adulto JovenRESUMEN
AIMS: A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. METHODS: We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. RESULTS: Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. CONCLUSION: This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators' meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631-637.
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BACKGROUND: Arthroscopic surgery for femoroacetabular impingement syndrome (FAI) is known to lead to self-reported symptom improvement. In the context of surgical interventions with known contextual effects and no true sham comparator trials, it is important to ascertain outcomes that are less susceptible to placebo effects. The primary aim of this trial was to determine if study participants with FAI who have hip arthroscopy demonstrate greater improvements in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to participants who undergo physiotherapist-led management. METHODS: Multi-centre, pragmatic, two-arm superiority randomised controlled trial comparing physiotherapist-led management to hip arthroscopy for FAI. FAI participants were recruited from participating orthopaedic surgeons clinics, and randomly allocated to receive either physiotherapist-led conservative care or surgery. The surgical intervention was arthroscopic FAI surgery. The physiotherapist-led conservative management was an individualised physiotherapy program, named Personalised Hip Therapy (PHT). The primary outcome measure was change in dGEMRIC score between baseline and 12 months. Secondary outcomes included a range of patient-reported outcomes and structural measures relevant to FAI pathoanatomy and hip osteoarthritis development. Interventions were compared by intention-to-treat analysis. RESULTS: Ninety-nine participants were recruited, of mean age 33 years and 58% male. Primary outcome data were available for 53 participants (27 in surgical group, 26 in PHT). The adjusted group difference in change at 12 months in dGEMRIC was -59 ms (95%CI - 137.9 to - 19.6) (p = 0.14) favouring PHT. Hip-related quality of life (iHOT-33) showed improvements in both groups with the adjusted between-group difference at 12 months showing a statistically and clinically important improvement in arthroscopy of 14 units (95% CI 5.6 to 23.9) (p = 0.003). CONCLUSION: The primary outcome of dGEMRIC showed no statistically significant difference between PHT and arthroscopic hip surgery at 12 months of follow-up. Patients treated with surgery reported greater benefits in symptoms at 12 months compared to PHT, but these benefits are not explained by better hip cartilage metabolism. TRIAL REGISTRATION DETAILS: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015.
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Pinzamiento Femoroacetabular , Fisioterapeutas , Adulto , Artroscopía , Australia , Femenino , Pinzamiento Femoroacetabular/diagnóstico por imagen , Pinzamiento Femoroacetabular/cirugía , Articulación de la Cadera/diagnóstico por imagen , Articulación de la Cadera/cirugía , Humanos , Masculino , Calidad de Vida , Resultado del TratamientoRESUMEN
AIMS: We report the long-term outcomes of the UK Heel Fracture Trial (HeFT), a pragmatic, multicentre, two-arm, assessor-blinded, randomized controlled trial. METHODS: HeFT recruited 151 patients aged over 16 years with closed displaced, intra-articular fractures of the calcaneus. Patients with significant deformity causing fibular impingement, peripheral vascular disease, or other significant limb injuries were excluded. Participants were randomly allocated to open reduction and internal fixation (ORIF) or nonoperative treatment. We report Kerr-Atkins scores, self-reported difficulty walking and fitting shoes, and additional surgical procedures at 36, 48, and 60 months. RESULTS: Overall, 60-month outcome data were available for 118 patients (78%; 52 ORIF, 66 nonoperative). After 60 months, mean Kerr-Atkins scores were 79.2 (SD 21.5) for ORIF and 76.4 (SD 22.5) for nonoperative. Mixed effects regression analysis gave an estimated effect size of -0.14 points (95% confidence interval -8.87 to 8.59; p = 0.975) in favour of ORIF. There were no between group differences in difficulty walking (p = 0.175), or on the type of shoes worn (p = 0.432) at 60 months. Additional surgical procedures were conducted on ten participants allocated ORIF, compared to four in the nonoperative group (p = 0.043). CONCLUSION: ORIF of displaced intra-articular calcaneal fractures, not causing fibular impingement, showed no difference in outcomes at 60 months compared to nonoperative treatment, but with an increased risk of additional surgery. Cite this article: Bone Joint J 2021;103-B(6):1040-1046.
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Calcáneo/lesiones , Tratamiento Conservador , Fijación Interna de Fracturas/métodos , Fracturas Intraarticulares/cirugía , Reducción Abierta/métodos , Adulto , Evaluación de la Discapacidad , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Dimensión del Dolor , Medición de Resultados Informados por el Paciente , Reino UnidoRESUMEN
AIMS: The primary aim of the survey was to map the current provision of simulation training within UK and Republic of Ireland (RoI) trauma and orthopaedic (T&O) specialist training programmes to inform future design of a simulation based-curriculum. The secondary aims were to characterize; the types of simulation offered to trainees by stage of training, the sources of funding for simulation, the barriers to providing simulation in training, and to measure current research activity assessing the educational impact of simulation. METHODS: The development of the survey was a collaborative effort between the authors and the British Orthopaedic Association Simulation Group. The survey items were embedded in the Performance and Opportunity Dashboard, which annually audits quality in training across several domains on behalf of the Speciality Advisory Committee (SAC). The survey was sent via email to the 30 training programme directors in March 2019. Data were retrieved and analyzed at the Warwick Clinical Trials Unit, UK. RESULTS: Overall, 28 of 30 programme directors completed the survey (93%). 82% of programmes had access to high-fidelity simulation facilities such as cadaveric laboratories. More than half (54%) had access to a non-technical skills simulation training. Less than half (43%) received centralized funding for simulation, a third relied on local funding such as the departmental budget, and there was a heavy reliance on industry sponsorship to partly or wholly fund simulation training (64%). Provision was higher in the mid-stages (ST3-5) compared to late-stages (ST6-8) of training, and was formally timetabled in 68% of prostgrammes. There was no assessment of the impact of simulation training using objective behavioural measures or real-world clinical outcomes. CONCLUSION: There is currently widespread, but variable, provision of simulation in T&O training in the UK and RoI, which is likely to expand further with the new curriculum. It is important that research activity into the impact of simulation training continues, to develop an evidence base to support investment in facilities and provision.
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AIMS: To develop a core outcome set of measurements from postoperative radiographs that can be used to assess technical skill in performing dynamic hip screw (DHS) and hemiarthroplasty, and to validate these against Van der Vleuten's criteria for effective assessment. METHODS: A Delphi exercise was undertaken at a regional major trauma centre to identify candidate measurement items. The feasibility of taking these measurements was tested by two of the authors (HKJ, GTRP). Validity and reliability were examined using the radiographs of operations performed by orthopaedic resident participants (n = 28) of a multicentre randomized controlled educational trial (ISRCTN20431944). Trainees were divided into novice and intermediate groups, defined as having performed < ten or ≥ ten cases each for DHS and hemiarthroplasty at baseline. The procedure-based assessment (PBA) global rating score was assumed as the gold standard assessment for the purposes of concurrent validity. Intra- and inter-rater reliability testing were performed on a random subset of 25 cases. RESULTS: In total, 327 DHS and 248 hemiarthroplasty procedures were performed by 28 postgraduate year (PGY) 3 to 5 orthopaedic trainees during the 2014 to 2015 surgical training year at nine NHS hospitals in the West Midlands, UK. Overall, 109 PBAs were completed for DHS and 80 for hemiarthroplasty. Expert consensus identified four 'final product analysis' (FPA) radiological parameters of technical success for DHS: tip-apex distance (TAD); lag screw position in the femoral head; flushness of the plate against the lateral femoral cortex; and eight-cortex hold of the plate screws. Three parameters were identified for hemiarthroplasty: leg length discrepancy; femoral stem alignment; and femoral offset. Face validity, content validity, and feasibility were excellent. For all measurements, performance was better in the intermediate compared with the novice group, and this was statistically significant for TAD (p < 0.001) and femoral stem alignment (p = 0.023). Concurrent validity was poor when measured against global PBA score. This may be explained by the fact that they are measuring difference facets of competence. Intra-and inter-rater reliability were excellent for TAD, moderate for lag screw position (DHS), and moderate for leg length discrepancy (hemiarthroplasty). Use of a large multicentre dataset suggests good generalizability of the results to other settings. Assessment using FPA was time- and cost-effective compared with PBA. CONCLUSION: Final product analysis using post-implantation radiographs to measure technical skill in hip fracture surgery is feasible, valid, reliable, and cost-effective. It can complement traditional workplace-based assessment for measuring performance in the real-world operating room . It may have particular utility in competency-based training frameworks and for assessing skill transfer from the simulated to live operating theatre.Cite this article: Bone Joint Open 2020;1-9:594-604.
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Hip preservation surgery is now an established part of orthopedic surgery and sports medicine. This report describes the key findings of the 11th Annual Scientific Meeting of International Society for Hip Arthroscopy-the International Hip Preservation Society-in Madrid, Spain from 16 to 19 October 2019. Lectures, seminars and debates explored the most up-to-date and expert views on a wide variety of subjects, including: diagnostic problems in groin pain, buttock pain and low back pain; surgical techniques in acetabular dysplasia, hip instability, femoroacetabular impingement syndrome, labral repair and reconstruction, cartilage defects, adolescent hips and gluteus medius and hamstring tears; and new ideas about femoral torsion, hip-spine syndrome, hip capsule surgery, impact of particular sports on hip injuries, registries, robotics and training for hip preservation specialists. Surgeons, sports physicians, radiologists and physiotherapists looking after young people with hip problems have an increasingly sophisticated armoury of ideas and techniques with which to help their patients. The concept of hip preservation has developed incredibly fast over the last decade; now it is clear that the best results can only be achieved by a multidisciplinary team working together. The 2020s will be the decade of 'Teamwork in Hip Preservation'.
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BACKGROUND: Robust assessment of skills acquisition and surgical performance during training is vital to ensuring operative competence among orthopaedic surgeons. A move to competency-based surgical training requires the use of tools that can assess surgical skills objectively and systematically. The aim of this systematic review was to describe the evidence for the utility of assessment tools used in evaluating operative performance in trauma and orthopaedic surgical training. METHODS: We performed a comprehensive literature search of MEDLINE, Embase, and Google Scholar databases to June 2019. From eligible studies we abstracted data on study aim, assessment format (live theater or simulated setting), skills assessed, and tools or metrics used to assess surgical performance. The strengths, limitations, and psychometric properties of the assessment tools are reported on the basis of previously defined utility criteria. RESULTS: One hundred and five studies published between 1990 and 2019 were included. Forty-two studies involved open orthopaedic surgical procedures, and 63 involved arthroscopy. The majority (85%) were used in the simulated environment. There was wide variation in the type of assessment tools in used, the strengths and weaknesses of which are assessor and setting-dependent. CONCLUSIONS: Current technical skills-assessment tools in trauma and orthopaedic surgery are largely procedure-specific and limited to research use in the simulated environment. An objective technical skills-assessment tool that is suitable for use in the live operative theater requires development and validation, to ensure proper competency-based assessment of surgical performance and readiness for unsupervised clinical practice. CLINICAL RELEVANCE: Trainers and trainees can gain further insight into the technical skills assessment tools that they use in practice through the utility evidence provided.
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Competencia Clínica/normas , Evaluación Educacional/métodos , Procedimientos Ortopédicos/normas , Humanos , Procedimientos Ortopédicos/educaciónRESUMEN
OBJECTIVE: The objectives of this study were to understand how cadaveric simulation impacts learning in orthopedic residents, why it is a useful training tool, and how skills learnt in the simulated environment translate into the workplace. DESIGN: This is a qualitative research study using in-depth, semistructured interviews with orthopedic residents who underwent an intensive cadaveric simulation training course. SETTING: The study was conducted at the University Hospital Coventry & Warwickshire, a tertiary care center with integrated cadaveric training laboratory in England, United Kingdom. PARTICIPANTS: Orthopedic surgery residents in the intervention group of a randomized controlled trial comparing intensive cadaveric simulation training with standard "on the job" training were invited to participate. Eleven of 14 eligible residents were interviewed (PGY 3-6, 8 male and 3 female). RESULTS: Learning from cadaveric simulation can be broadly categorized into intrinsic, surgeon-driven factors, and extrinsic environmental factors. Intrinsic factors include participant ability to "buy-in" to the simulation exercise, willingness to push one's own learning boundaries in a "safe space" and take out on resident experience and self-reported confidence, with the greatest learning gains seen at around the PGY4 stage in individuals who reported low preintervention operative confidence. Extrinsic factors included; the opportunity to perform operations in their entirety without external pressures or attending "take-over," leading to subjective improvement in participant operative fluency and confidence. The intensive supervision of subspecialist attending surgeons giving real-time performance feedback, tips and tricks, and the opportunity to practice unusual approaches was highly valued by participants, as was paired learning with alternating roles as primary surgeon/assistant and multidisciplinary involvement of scrub-staff and radiographers. Cadaveric simulation added educational value beyond that obtained in low-fidelity simulation training by "stirring into practice" and "becoming through doing." In providing ultrarealistic representation of the space, ritualism, and costuming of the operating theater, cadaveric simulation training also enabled the development of a range of nontechnical skills and sociocultural "nontechnical" lessons of surgery. CONCLUSIONS: Cadaveric simulation enhances learning in both technical and nontechnical skills in junior orthopedic residents within a single training package. Direct transfer of skills learnt in the simulation training to the real-world operating theater, with consequent patient benefit, was reported. Cadaveric simulation in the UK training system of orthopedics may be of greatest utility at around the PGY 4 stage, at which point operative fluency, independence, and confidence can be rapidly improved in the cadaveric laboratory, to enable the attainment of competence in index trauma operations.
Asunto(s)
Internado y Residencia , Ortopedia , Entrenamiento Simulado , Cadáver , Competencia Clínica , Educación de Postgrado en Medicina , Inglaterra , Femenino , Humanos , Masculino , Reino UnidoRESUMEN
BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery, including reshaping the hip, or with physiotherapist-led conservative care. We aimed to compare the clinical effectiveness of hip arthroscopy with best conservative care. METHODS: UK FASHIoN is a pragmatic, multicentre, assessor-blinded randomised controlled trial, done at 23 National Health Service hospitals in the UK. We enrolled patients with femoroacetabular impingement syndrome who presented at these hospitals. Eligible patients were at least 16 years old, had hip pain with radiographic features of cam or pincer morphology but no osteoarthritis, and were believed to be likely to benefit from hip arthroscopy. Patients with bilateral femoroacetabular impingement syndrome were eligible; only the most symptomatic hip was randomly assigned to treatment and followed-up. Participants were randomly allocated (1:1) to receive hip arthroscopy or personalised hip therapy (an individualised, supervised, and progressive physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre and was done by research staff at each hospital, using a central telephone randomisation service. Patients and treating clinicians were not masked to treatment allocation, but researchers who collected the outcome assessments and analysed the results were masked. The primary outcome was hip-related quality of life, as measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed in all eligible participants who were allocated to treatment (the intention-to-treat population). This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN64081839, and is closed to recruitment. FINDINGS: Between July 20, 2012, and July 15, 2016, we identified 648 eligible patients and recruited 348 participants: 171 participants were allocated to receive hip arthroscopy and 177 to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (319 of 348 participants). At 12 months after randomisation, mean iHOT-33 scores had improved from 39·2 (SD 20·9) to 58·8 (27·2) for participants in the hip arthroscopy group, and from 35·6 (18·2) to 49·7 (25·5) in the personalised hip therapy group. In the primary analysis, the mean difference in iHOT-33 scores, adjusted for impingement type, sex, baseline iHOT-33 score, and centre, was 6·8 (95% CI 1·7-12·0) in favour of hip arthroscopy (p=0·0093). This estimate of treatment effect exceeded the minimum clinically important difference (6·1 points). There were 147 patient-reported adverse events (in 100 [72%] of 138 patients) in the hip arthroscopy group) versus 102 events (in 88 [60%] of 146 patients) in the personalised hip therapy group, with muscle soreness being the most common of these (58 [42%] vs 69 [47%]). There were seven serious adverse events reported by participating hospitals. Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment, and the one in the personalised hip therapy group was not. There were no treatment-related deaths, but one patient in the hip arthroscopy group developed a hip joint infection after surgery. INTERPRETATION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement than did personalised hip therapy, and this difference was clinically significant. Further follow-up will reveal whether the clinical benefits of hip arthroscopy are maintained and whether it is cost effective in the long term. FUNDING: The Health Technology Assessment Programme of the National Institute of Health Research.
Asunto(s)
Artroscopía , Tratamiento Conservador , Pinzamiento Femoroacetabular/rehabilitación , Pinzamiento Femoroacetabular/cirugía , Modalidades de Fisioterapia , Adulto , Femenino , Pinzamiento Femoroacetabular/diagnóstico , Humanos , Masculino , Persona de Mediana Edad , Medición de Resultados Informados por el Paciente , Calidad de Vida , Rango del Movimiento Articular , Resultado del Tratamiento , Reino UnidoRESUMEN
BACKGROUND: Femoroacetabular impingement syndrome (FAI), a hip disorder affecting active young adults, is believed to be a leading cause of hip osteoarthritis (OA). Current management approaches for FAI include arthroscopic hip surgery and physiotherapy-led non-surgical care; however, there is a paucity of clinical trial evidence comparing these approaches. In particular, it is unknown whether these management approaches modify the future risk of developing hip OA. The primary objective of this randomised controlled trial is to determine if participants with FAI who undergo hip arthroscopy have greater improvements in hip cartilage health, as demonstrated by changes in delayed gadolinium-enhanced magnetic resonance imaging (MRI) of cartilage (dGEMRIC) index between baseline and 12 months, compared to those who undergo physiotherapy-led non-surgical management. METHODS: This is a pragmatic, multi-centre, two-arm superiority randomised controlled trial comparing hip arthroscopy to physiotherapy-led management for FAI. A total of 140 participants with FAI will be recruited from the clinics of participating orthopaedic surgeons, and randomly allocated to receive either surgery or physiotherapy-led non-surgical care. The surgical intervention involves arthroscopic FAI surgery from one of eight orthopaedic surgeons specialising in this field, located in three different Australian cities. The physiotherapy-led non-surgical management is an individualised physiotherapy program, named Personalised Hip Therapy (PHT), developed by a panel to represent the best non-operative care for FAI. It entails at least six individual physiotherapy sessions over 12 weeks, and up to ten sessions over six months, provided by experienced musculoskeletal physiotherapists trained to deliver the PHT program. The primary outcome measure is the change in dGEMRIC score of a ROI containing both acetabular and femoral head cartilages at the chondrolabral transitional zone of the mid-sagittal plane between baseline and 12 months. Secondary outcomes include patient-reported outcomes and several structural and biomechanical measures relevant to the pathogenesis of FAI and development of hip OA. Interventions will be compared by intention-to-treat analysis. DISCUSSION: The findings will help determine whether hip arthroscopy or an individualised physiotherapy program is superior for the management of FAI, including for the prevention of hip OA. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry reference: ACTRN12615001177549 . Trial registered 2/11/2015 (retrospectively registered).
Asunto(s)
Artroscopía/métodos , Pinzamiento Femoroacetabular/epidemiología , Pinzamiento Femoroacetabular/terapia , Articulación de la Cadera/cirugía , Modalidades de Fisioterapia , Australia/epidemiología , Femenino , Pinzamiento Femoroacetabular/diagnóstico por imagen , Articulación de la Cadera/diagnóstico por imagen , Humanos , Masculino , Método Simple Ciego , Resultado del TratamientoRESUMEN
INTRODUCTION: Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. METHODS: In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. RESULTS: The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26â weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6â weeks, but there were no serious adverse events. CONCLUSION: PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). TRIAL REGISTRATION NUMBER: ISRCTN 09754699.
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Protocolos Clínicos , Terapia por Ejercicio/métodos , Pinzamiento Femoroacetabular/terapia , Articulación de la Cadera/fisiopatología , Adulto , Congresos como Asunto , Femenino , Humanos , Masculino , Dolor Musculoesquelético/etiología , Dolor Musculoesquelético/terapiaRESUMEN
BACKGROUND: Microvascular blood flow in the tendon plays an important role in the pathogenesis of rotator cuff abnormalities. There are conflicting views about the presence of a hypovascular zone in the supraspinatus tendon. Besides, no studies have looked at the pattern of blood flow around a partial-thickness tear. Our aim was to measure microvascular blood flow in normal and a range of pathologic rotator cuff tendons using laser doppler flowmetry. METHODS: A total of 120 patients having arthroscopic shoulder surgery were divided into 4 equal groups on the basis of their intraoperative diagnosis: normal rotator cuff, subacromial impingement syndrome, and partial-thickness or full-thickness rotator cuff tear. Microvascular blood flow was measured at 5 different regions of each cuff using a laser doppler probe. The values were compared to assess variability within and between individuals. RESULTS: Total blood flow was greater in the normal rotator cuff group compared with the groups with pathologic rotator cuffs, with the largest difference seen in the subacromial impingement group. Within individuals, blood flow was highest at the musculotendinous junction and lowest at the lateral insertional part of the tendon. Among groups, the blood flow was significantly lower at the anteromedial and posteromedial cuff in the groups with impingement and full-thickness tears compared with the group with normal cuff. CONCLUSION: Real-time in vivo laser doppler analysis has shown that microvascular blood flow is not uniform throughout the supraspinatus tendon. Blood flow in the pathologic supraspinatus tendon was significantly lower compared with the normal tendon.