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PURPOSE: Establishing the diagnosis of loosening in total or unicondylar knee arthroplasty remains a challenge with different clinical and radiological signs evaluated in study designs with high risk of bias, where few or incomplete criteria are formulated for establishing the diagnosis of implant loosening. This study aimed at evaluating the variability between different clinical and radiological criteria and establish a consensus regarding clinical and radiological criteria for the diagnosis of knee arthroplasty loosening. METHODS: Highly specialized knee surgeons focusing on revision arthroplasty were invited to take part in an international panel for a Delphi consensus study. In the first round, the participants were asked to state their most important clinical and radiological criteria for implant loosening. In a second round, the panel's agreement with the collected criteria was rated on a 5-point Likert scale (1-5). High variability was defined by receiving at least one score each indicating complete disagreement and complete agreement. Consensus was established when over 70% of participants rated a criterion as 'fully agree' (5) or 'mostly agree' (4). RESULTS: High variability was observed in 56% of clinical criteria and 38% of radiological criteria. A consensus was reached on one clinical (weight-bearing pain [82%]) and four radiological criteria, that is, implant migration, progressive radiolucencies, subsidence and radiolucencies >2 mm on X-ray or computed tomography (CT) (84%-100%). CONCLUSION: Amongst specialized knee revision surgeons, there is high variability in clinical and radiological criteria that are seen as important contributing factors to diagnosis of knee implant loosening. A consensus was reached on weight-bearing pain as clinical criterion and on implant migration, progressive radiolucencies, subsidence and radiolucencies of more than 2 mm on X-ray or CT as radiological criteria. The variability rates observed, along with the criteria that reached consensus, offer important insights for the standardization of diagnostic protocols. LEVEL OF EVIDENCE: Level V.
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PURPOSE: There is a lack of a clear, uniform definition for intraoperatively assessed component loosening of a knee arthroplasty component, complicating the interpretation and interchangeability of results of diagnostic studies using an intraoperative observation as the reference test. The purpose of this study was to establish a consensus among specialised knee revision surgeons regarding the definition of intraoperatively determined loosening of total or unicondylar knee arthroplasty components. METHODS: Utilising the Delphi consensus method, an international panel of highly specialised knee revision surgeons was invited to participate in a three-round process. The initiation of the first round involved the exploration of possible criteria for intraoperatively determined loosening with open questions. The second round focused on rating these criteria importance on a five-point Likert scale. For the third round, criteria that reached consensus were summarised in consecutive definitions for intraoperatively determined loosening and proposed to the panel. Consensus was established when over 70% of participants agreed with a definition for intraoperatively determined loosening. RESULTS: The 34 responding panel members described in total 60 different criteria in the first round of which 34 criteria received consensus in the second round. Summarising these criteria resulted in four different definitions as minimal requirements for intraoperatively determined loosening. Eighty-eight percent of the panel members agreed on defining a component as loose if there is visible fluid motion at the interface observed during specific movements or when gently applying direct force. CONCLUSION: This study successfully established a consensus using a Delphi method among knee revision surgeons on the definition of intraoperatively determined component loosening. By agreeing on the visibility of fluid motion as new definition, this study provides a standardised reference for future diagnostic research. This definition will enhance the interpretability and interchangeability of future diagnostic studies evaluating knee arthroplasty component loosening. LEVEL OF EVIDENCE: Level V.
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PURPOSE: Aseptic loosening often requires major, expensive and invasive revision surgery. Current diagnostic modalities merely show indirect signs of loosening. A recent proof of concept study proposed a non-invasive technique for the quantitative and visual assessment of implant movement as a diagnostic aid for tibial component loosening. The primary research question addressed is whether this novel diagnostic modality can safely and effectively aid the diagnosis of aseptic loosening. METHODS: This clinical study included patients suspected of aseptic total knee arthroplasty (TKA) loosening listed for revision surgery and asymptomatic patients. Safety was evaluated using a numerical rating scale (NRS) for discomfort and by registration of adverse events. Feasibility was assessed by recording the duration and ease of the procedure. Intra- and interrater reliability were evaluated. In symptomatic patients, diagnostic accuracy metrics were evaluated with intra-operative assessment as a reference test. RESULTS: In total, 34 symptomatic and 38 asymptomatic knees with a TKA were analysed. The median NRS for discomfort during loading was 6 (interquartile range [IQR]: 3.75-7.00) in symptomatic patients and 2 (IQR: 1.00-3.00) in asymptomatic patients. No adverse events were reported. The majority of users found the use of the loading device easy. The median time spent in the computed tomography room was 9 min (IQR: 8.00-11.00). Excellent to good intra- and interrater reliabilities were achieved. Diagnostic accuracy analysis resulted in a sensitivity of 0.91 (95% confidence interval [CI]: 0.72-0.97) and a specificity of 0.72 (95% CI: 0.43-0.90). CONCLUSIONS: The proposed diagnostic method is safe, feasible, reliable and accurate in aiding the diagnosis of aseptic tibial component loosening. LEVEL OF EVIDENCE: Level II.
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PURPOSE: The purpose of this study was to evaluate and compare the diagnostic accuracy of modalities used to aid the diagnosis of aseptic knee arthroplasty loosening. METHODS: A comparative diagnostic test accuracy systematic review and meta-analysis was conducted following the Cochrane and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. PubMed, EMBASE and Cochrane databases were searched for original articles evaluating diagnostic modalities up to March 2024. Included studies compared the modality (index test) to the intraoperative finding as reference test. The QUADAS-C (Quality Assessment of Diagnostic Accuracy Studies-Comparative) tool was used to assess the quality of the included studies. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach was used to evaluate the certainty of evidence. Level of evidence was evaluated using the Oxford Levels of Evidence tool. The primary outcome was the summary of diagnostic accuracy metrics for each modality as demonstrated by a summary receiver-operating characteristic (SROC) curve. RESULTS: The search yielded 467 articles. Of these, 14 articles were included. These 14 articles evaluated a total of five different diagnostic modalities: bone scintigraphy (three studies, 146 cases), 18-fluorodeoxyglucose positron emission tomography (two studies, 50 cases), single-photon emission computed tomography combined with computed tomography (SPECT/CT) (seven studies, 371 cases), radionuclide arthrogram (three studies, 196 cases) and magnetic resonance imaging (MRI) (one study, 116 cases). Nine studies exhibited a high risk of bias in patient selection, and all studies showed a high risk of bias related to the reference test. The majority of the included studies were classified as Level III evidence, leading to an overall low level of certainty in the evidence. The most accurate tests, as demonstrated by the SROC analysis, were MRI and SPECT/CT, with sensitivities ranging from 0.00 to 1.00 and 0.33 to 1.00 and specificities between 0.31-1.00 and 0.00-1.00, respectively. CONCLUSIONS: This review and meta-analysis evaluated available diagnostic modalities to aid the diagnosis of knee arthroplasty loosening and based on a low certainty of evidence suggests that MRI and SPECT/CT are currently the most accurate modalities available to aid the diagnosis of aseptic loosening of knee arthroplasty components. LEVEL OF EVIDENCE: Level III.
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Artroplastia de Reemplazo de Rodilla , Imagen por Resonancia Magnética , Falla de Prótesis , Humanos , Tomografía Computarizada por Tomografía Computarizada de Emisión de Fotón Único , Sensibilidad y EspecificidadRESUMEN
BACKGROUND: Total hip arthroplasty (THA) in teenagers is generally avoided. Nevertheless, recent THA procedures in a very young patient show improved functional outcomes and implant survival, resulting in lower revision rates. This review aims to present an overview of the available literature on THA in teenagers and to provide evidence to inform caregivers. METHODS: In this systematic review, studies required a primary THA method and a teenage patient population. Studies must report at least one of the following outcome measures: functional outcomes, implant survival, and complications. In addition, demographic and surgical data were collected. RESULTS: Sixteen studies were analyzed, including 2040 patients and 2379 hips, with an average 7.7-year follow-up. The mean patient age was 18 years, with an average revision rate of 11.7%. The overall average relative improvement of the 2 most frequently used patient-reported (functional) outcome measures were 84.3 and 92.3% at the latest follow-up. Prosthesis, or liner loosening, was the cause of revision in 50.2% of the cases. Loosening was the most frequent complication (14.8%), together with prosthesis/liner wear (14.8%). Cementless fixation (70.7%), ceramic-on-ceramic articulation (34.7%), and the posterior surgical approach (82.3%) were the most applied techniques. CONCLUSIONS: The functional outcomes after THA in teenagers improved at follow-up. The average revision rate is relatively high, especially in the pre-1995 studies, with post-1995 studies reporting similar revision rates to the adult patient group. Research to further improve implant survival as well as the ease of revisions in teenagers is needed. LEVEL OF EVIDENCE: Level III-systematic review.
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Artroplastia de Reemplazo de Cadera , Prótesis de Cadera , Adulto , Humanos , Adolescente , Artroplastia de Reemplazo de Cadera/métodos , Articulación de la Cadera/cirugía , Estudios de Seguimiento , Resultado del Tratamiento , Estudios Retrospectivos , Falla de Prótesis , Reoperación , Diseño de PrótesisRESUMEN
BACKGROUND: After total knee arthroplasty up to 13% requires revision surgery to address loosening. No current diagnostic modalities have a sensitivity or specificity higher than 70-80% to detect loosening, leading to 20-30% of patients undergoing unnecessary, risky and expensive revision surgery. A reliable imaging modality is required to diagnose loosening. This study presents a new and non-invasive method and evaluates its reproducibility and reliability in a cadaveric study. METHODS: Ten cadaveric specimens were implanted with a loosely fitted tibial components and CT scanned under load towards valgus and varus using a loading device. Advanced three-dimensional imaging software was used to quantify displacement. Subsequently, the implants were fixed to the bone and scanned to determine the differences between the fixed and the loose state. Reproducibility errors were quantified using a frozen specimen in which displacement was absent. FINDINGS: Reproducibility errors, expressed as mean target registration error, screw-axis rotation and maximum total point motion were 0.073 mm (SD 0.033), 0.129 degrees (SD 0.039) and 0.116 mm (SD 0.031), respectively. In the loose condition, all displacements and rotation changes were larger than the reported reproducibility errors. Comparing the mean target registration error, screw axis rotation and maximum total point motion in the loose condition to the fixed condition resulted in mean differences of 0.463 mm (SD 0.279; p = 0.001), 1.769 degrees (SD 0.868; p < 0.001) and 1.339 mm (SD 0.712; p < 0.001), respectively. INTERPRETATION: The results of this cadaveric study show that this non-invasive method is reproducible and reliable for detection of displacement differences between fixed and loose tibial components.
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Imagenología Tridimensional , Prótesis de la Rodilla , Humanos , Reproducibilidad de los Resultados , Falla de Prótesis , Tomografía Computarizada por Rayos X , Rotación , Cadáver , Articulación de la Rodilla/diagnóstico por imagen , Articulación de la Rodilla/cirugíaRESUMEN
STUDY DESIGN: Cross-sectional validation study. OBJECTIVE: The aim was to validate the AO Spine Patient-Reported Outcome Spine Trauma (PROST) at a minimum of 12 months posttrauma and to evaluate patient characteristics, types of spine fractures, and treatment strategies as determinants of AO Spine PROST scores. SUMMARY OF BACKGROUND DATA: The reliability and validity of the AO Spine PROST as a measure of health-related quality of life for more than 12 months after onset of spine trauma is unclear. MATERIALS AND METHODS: Patients with a traumatic spine injury were recruited from a level-1 trauma center. They were asked to complete the AO Spine PROST, EuroQoL 5D-5L (EQ-5D-5L), and either Oswestry disability index (ODI) or neck disability index (NDI) for concurrent validity. Internal consistency was assessed by calculating the Cronbach α and item-total correlation coefficients. Test-retest reliability was evaluated using intraclass correlation coefficients. Spearman correlation tests were performed for the AO Spine PROST in correlation with the EQ-5D-5L, and either ODI or NDI. Determinants for AO Spine PROST score were analyzed using multivariate regression models. RESULTS: A total of 175 patients participated in the cross-sectional arm and 49 in the test-retest arm of the study. Median duration of follow-up was 94.5 months. No floor or ceiling effects were seen. Internal consistency was excellent (α=0.98, item-total correlation coefficient: 0.73-0.91) as well as test-retest reliability (intraclass correlation coefficient=0.81). Satisfactory correlations were seen for the EQ-5D-5L (0.76; P <0.001), ODI (0.69; P <0.001), and NDI (0.68; P <0.001) with the AO Spine PROST. Multivariate linear regression models showed that having ≥1 comorbidities, duration of return to work within the range of 7 to 43 months and no return to work were significant independent determinants for a worse AO Spine PROST score. CONCLUSIONS: Very good long-term reliability and validity results were found for the AO Spine PROST.
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Calidad de Vida , Traumatismos Vertebrales , Estudios Transversales , Humanos , Medición de Resultados Informados por el Paciente , Psicometría , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Transferencia Intrafalopiana del CigotoRESUMEN
PURPOSE/OBJECTIVE: This multicenter study assessed the incidence and survival of patients with esophagogastric cancer and oligometastatic disease (OMD) in two tertiary referral cancer centers in The Netherlands and Switzerland. MATERIALS/METHODS: Between 2010 and 2021, patients with metastatic esophagogastric cancer were identified. Patients with de-novo OMD were included (first-time diagnosis of ≤5 distant metastases on 18F-FDG-PET/CT). Control of the primary tumor was considered in patients who underwent primary tumor resection or definitive chemoradiotherapy without locoregional recurrence. Treatment of OMD was categorized into (1) systemic therapy, (2) local treatment (stereotactic body radiotherapy or metastasectomy), (3) local plus systemic therapy, or (4) best supportive care. The primary outcomes were overall survival (OS) and independent prognostic factors for OS. Independent prognostic factors for OS were analyzed using multivariable Cox proportional hazard models. RESULTS: In total, 830 patients with metastatic esophagogastric cancer were identified of whom 200 patients with de-novo OMD were included (24%). The majority of included patients had esophageal cancer (73%) with adenocarcinoma histology (79%) and metachronous OMD (52%). The primary tumor was controlled in 68%. Treatment of OMD was systemic therapy (25%), local treatment (43%), local plus systemic therapy (13%), or best supportive care (18%). Median follow-up was 14 months (interquartile range: 7-27). Median OS was 16 months (95% CI: 13-21). Improved OS was independently associated with local plus systemic therapy compared with systemic therapy alone (hazard ratio [HR] 0.47, 95% confidence interval [CI]: 0.25-0.87). Worse OS was independently associated with squamous cell carcinoma (HR 1.70, 95% CI: 1.07-2.74), bone oligometastases (HR 2.44, 95% CI: 1.28-4.68), brain oligometastases (HR 1.98, 95% CI: 1.05-4.69), and two metastatic locations (HR 2.07, 95% CI: 1.04-4.12). Median OS after local plus systemic therapy was 35 months (95% CI: 22-NA) as compared with 13 months (95% CI: 9-21, p < 0.001) after systemic therapy alone for OMD. CONCLUSION: Patients with metastatic esophagogastric cancer present in 25% with de-novo OMD. Local treatment of OMD plus systemic therapy was independently associated with long-term OS and independently improved OS when compared with systemic therapy alone. Randomized controlled trials are warranted to confirm these results.
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Neoplasias Esofágicas , Neoplasias Primarias Secundarias , Radiocirugia , Neoplasias Gástricas , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/terapia , Humanos , Incidencia , Recurrencia Local de Neoplasia , Tomografía Computarizada por Tomografía de Emisión de Positrones , Radiocirugia/métodos , Estudios Retrospectivos , Neoplasias Gástricas/terapiaRESUMEN
BACKGROUND: The primary goal of this study was to determine overall survival (OS) in patients who underwent local treatment (metastasectomy or stereotactic body radiotherapy [SBRT]) or systemic therapy (chemotherapy or targeted therapy) for oligometastatic esophagogastric cancer. The secondary goal was to determine prognostic factors for OS. METHODS: Patients with synchronous or metachronous oligometastatic esophagogastric cancer who underwent local treatment or systemic therapy were included in this single-center, retrospective cohort study. Oligometastatic disease (OMD) included 1 organ or 1 extraregional lymph node station with ≤ 3 lesions. OS was determined after OMD detection. Treatment for OMD was categorized as (1) local treatment, (2) local plus systemic, (3) systemic therapy. The primary tumor was controlled after resection or definitive chemoradiotherapy. RESULTS: In total, 85 patients were included. Treatment for OMD was local treatment (58%), local plus systemic (14%), or systemic therapy (28%). The primary tumor was controlled in 68% of patients. Most patients were diagnosed with distal esophageal cancer (61%), with adenocarcinoma histology (76%), and presented with synchronous OMD (51%). OS after local treatment was 17 months (95% confidence interval [CI] 12-40), after local plus systemic therapy 35 months (95% CI 29-NA), and after systemic therapy 16 months (95% CI 11-NA). Better OS was independently associated with local plus systemic compared with local treatment (hazard ratio [HR] 2.11, 95% CI 1.05-5.07) or systemic therapy (HR 2.28, 95% CI 1.04-6.07). CONCLUSIONS: Local plus systemic therapy for oligometastatic esophagogastric cancer was independently associated with improved OS and better OS compared with either systemic therapy or local treatment.