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Vertebral bodies are one of the most common metastasis sites found in advanced prostate cancer and have a significant impact on patients' quality of life. Spinal metastases frequently cause severe back pain and in some occasions can lead to secondary complications, with serious neurological deficits and loss of function. The main treatment goals include adequate pain management, controlling tumour growth and restoring spinal stability. Publications on the role of surgery - both conventional and stereotactic radiotherapy, and either as an individual modality or in combination - have been inconclusive. The NOMS score has proven to be useful in making treatment decisions. Existing data show better outcomes in patients with surgical therapy, both when performed in isolation and also combined with radiotherapy, in which some of the cohorts studied including patients with primary cancer other than prostate cancer. Comparative studies that specifically investigate the superiority of specific therapy modalities for metastatic prostate carcinoma are scarce. Similarly, there are limited data on microsurgical interventions for spinal metastases. Radiotherapy alone is crucial in the setting of palliation, especially for pain relief, and its effectiveness has been shown in many studies. The patient's life expectancy plays a crucial role in deciding the most appropriate treatment approach. Given the complexity of the patient population, a multimodal therapy approach is necessary. Current trends in therapy favour greater use of surgical interventions, particularly in the early detection of spinal metastases.
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Neoplasias da Próstata , Compressão da Medula Espinal , Neoplasias da Coluna Vertebral , Masculino , Humanos , Compressão da Medula Espinal/etiologia , Compressão da Medula Espinal/cirurgia , Compressão da Medula Espinal/radioterapia , Neoplasias da Coluna Vertebral/complicações , Neoplasias da Coluna Vertebral/radioterapia , Qualidade de Vida , Terapia Combinada , Neoplasias da Próstata/radioterapiaRESUMO
BACKGROUND: While predictors for postoperative survival in spine tumour patients have been identified, there is limited evidence for predictors of postoperative Quality of Life (QoL), pain and functional outcome. METHODS: One hundred and fifty-three consecutive patients, who had undergone surgery for symptomatic spinal metastases between June 2016 and April 2019, were interviewed preoperatively and during follow-ups at three, six and 12 months using the EQ-5D-3L, COMI, and ODI questionnaires. Differences in means exceeding the specific Minimal Clinically Important Difference (MCID) values were considered clinically significant. RESULTS: Thirty-three percent of the patients were reported dead after 12 months. Only one metastasis compared to multiple metastases has 7.9 the Odds for an improved EQ-5D-3L score at three months. No neoadjuvant metastatic irradiation has 6.8 the Odds for the improvement at that time against performed radiation. A preoperative ODI score between 50.1 and 100 has 22.0 times the odds compared to the range from 0 to 50 for an improved EQ-5D-3L after three months, and 12.5 times the odds in favour of improved COMI after three months, and 13.6 times the odds for improvement of ODI at the three-month follow-up. A preoperative COMI score ranging from 5.0 to 10 has 21 times the odds of a COMI between 0 and 5 for an improved EQ-5D-3L score and 11 times the odds for an improved ODI after 12 months. Other predictors showed no statistically significant improvement. CONCLUSION: An improvement in QoL, pain and spinal function after 12 months can be predicted by a subjective preoperative poor health condition. Impaired spinal function before surgery, a singular metastasis and no previous irradiation is predictive of improved spinal function and quality of life three months after surgery.
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Neoplasias , Qualidade de Vida , Humanos , Resultado do Tratamento , Dor Pós-OperatóriaRESUMO
STUDY DESIGN: retrospective study. OBJECTIVES: In addition to surgical treatment of spinal epidural abscesses (SEA), a conservative, medical treatment for patients without acute neurologic deficits has been proposed. However, the risk factors for neurologic deficits are unclear. This study aims to identify factors predisposing patients with SEA to neurological impairment. METHODS: All patients treated for SEA between 2008 and 2021 were identified from a prospective vertebral-osteomyelitis registry of a tertiary referral centre. Patient demographics, comorbidities, pathogens, degree of osseous destruction, location of SEA and preoperative neurologic status were retrospectively collected. Differences between patients with (Group 1) and without (Group 2) pretreatment neurologic deficits were assessed by univariate and logistic regression analysis. RESULTS: A total of 140 patients with SEA were included. Forty-three patients (31%) had a neurologic deficit and 97 patients (69%) had no neurologic deficit prior to therapy. The prevalence of diabetes mellitus (35% vs 19%, P = .03), median visual analogue scale leg pain (8 vs 5, P = .01), median American Society of Anesthesiologists (ASA) Score (3 vs 2.6, P = .003) and mean Body-Mass-Index (29 vs 26, P = .02) differed between Group 1 and 2 in univariate analysis. In multivariable analysis, diabetes mellitus (odds ratio = 2.7), female sex (odds ratio = 2.5) and ASA-Score (odds ratio = 2.4) were significant contributors for neurologic deficits. CONCLUSIONS: In patients with a SEA without neurologic deficits, the ASA score and diabetes mellitus should be considered, especially in female patients. These patients may be at a higher risk for developing a neurologic deficit and may benefit from an early surgical treatment.
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Tumors of the spine are challenging in terms of diagnoses and interdisciplinary treatment. This study was conducted to evaluate and characterize a large multicenter cohort of surgically treated spine tumor patients.Data of the German Spine Society (DWG) were used to characterize a cohort of all surgically treated spine tumor cases that were registered between 2017 and 2021. Subgroup analysis was performed for tumor entity, tumor localization, height of most severely affected segments, surgical treatment, and demographic parameters.In total, there were 9686 cases, of which 6747 were "malignant", 1942 were "primary benign", 180 were "tumor-like lesions", and 488 were "other" spinal tumors. Subgroups showed differences in number of affected segments as well as localization. There were further significant differences in surgical complication rates (p = 0.003), age (p < 0.001), morbidity (p < 0.001), and duration of surgery (p = 0.004).This is a representative study on spinal tumors from a large spine registry and allows for the epidemiological characterization of surgically treated tumor subgroups and quality control of registry data.
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BACKGROUND: Osteosarcoma and Ewing's sarcoma in children and adolescents require age-specific interdisciplinary diagnosis and treatment to achieve optimal therapeutic outcomes. METHODS: The diagnosis and treatment of malignant bone tumors in childhood and adolescence are presented in the light of publications retrieved by a selective search, pertinent guidelines, and the authors' extensive experience in an interdisciplinary cancer center. RESULTS: Bone sarcomas make up approximately 5% of all malignancies in children and adolescents; the most common types are Ewing's sarcoma and osteosarcoma. Patients are often not referred to a specialized center until long after the onset of symptoms, as they and their physicians rarely consider the possibility of a bone tumor, and the symptoms are often trivialized. Bone pain of unknown origin, swelling, and functional limitations should be investigated with conventional x-rays. Lesions of unclear origin should be biopsied after a meticulous clinical and radiologic evaluation. Multimodal treatment consists of neo - adjuvant chemotherapy, limb-preserving resection if possible, and radiotherapy where indicated. In multicenter studies, patients with osteosarcoma achieve event-free survival in 64% of cases if their disease is localized, and 28% if it is metastatic; the corresponding figures for patients with Ewing's sarcoma are 80% and 27%, respectively. CONCLUSION: With implementation of the current treatment recommendations, most children and adolescents with malignant bone tumors can be treated successfully with curative intent. These patients should be referred to a sarcoma center for diagnosis and treatment.
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Neoplasias Ósseas , Osteossarcoma , Sarcoma de Ewing , Humanos , Criança , Adolescente , Sarcoma de Ewing/terapia , Sarcoma de Ewing/tratamento farmacológico , Osteossarcoma/terapia , Osteossarcoma/tratamento farmacológico , Neoplasias Ósseas/terapia , Neoplasias Ósseas/tratamento farmacológico , Terapia CombinadaRESUMO
BACKGROUND: Surgical decompression (SD) followed by radiotherapy (RT) is superior to RT alone in patients with metastatic spinal disease with epidural spinal cord compression (ESCC) and neurological deficit. For patients without neurological deficit and low- to intermediate-grade intraspinal tumor burden, data on whether SD is beneficial are scarce. This study aims to investigate the neurological outcome of patients without neurological deficit, with a low- to intermediate-ESCC, who were treated with or without SD. METHODS: This single-center, multidepartment retrospective analysis includes patients treated for spinal epidural metastases from 2011 to 2021. Neurological status was assessed by Frankel grade, and intraspinal tumor burden was categorized according to the ESCC scale. Spinal instrumentation surgery was only considered as SD if targeted decompression was performed. RESULTS: ESCC scale was determined in 519 patients. Of these, 190 (36.6%) presented with no neurological deficit and a low- to intermediate-grade ESCC (1b, 1c, or 2). Of these, 147 (77.4% were treated with decompression and 43 (22.65%) without. At last follow-up, there was no difference in neurological outcome between the two groups. CONCLUSIONS: Indication for decompressive surgery in neurologically intact patients with low-grade ESCC needs to be set cautiously. So far, it is unclear which patients benefit from additional decompressive surgery, warranting further prospective, randomized trials for this significant cohort of patients.
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There is an ongoing debate whether a surgical drainage is beneficial to prevent local accumulation of hematoma and to reduce the rate of wound infections, and neurological deficits. Data from the German Spine Society (DWG) registry were filtered for surgically treated spine tumor cases between 2017 and 2021. Cases were categorized into with (Group I) and without (Group II) placement of a surgical drainage. Subgroups were compared for demographic data, type of surgery, experience of the surgeon and postoperative surgical complications. 10,029 cases were included into final analysis (Group I: 3007; Group II: 7022). There was no significant difference between both groups regarding age or gender distribution. Average morbidity of patients was significantly elevated in Group I (p < 0.05) and the rates of invasive surgery were significantly increased in this group (p < 0.001). Overall complication rates were reported with 12.0% (Group I) and 8.5% (Group II). There were significantly more epidural hematoma (p < 0.001) and motor dysfunction (p = 0.049) as well as deep wound infections (p < 0.001) and implant failures (p = 0.02) in Group I. A surgical wound drainage cannot prevent epidural hematoma.
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Hematoma Epidural Craniano , Neoplasias , Infecção dos Ferimentos , Humanos , Sistema de Registros , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Drenagem/efeitos adversos , Neoplasias/complicaçõesRESUMO
Pediatric spondylodiscitis (PSD) is a rare disease with a major impact on mobility and functional status. Data concerning demographic and microbiological characteristics, clinical course, treatment, and outcome are scarce. Therefore, the aim of this study was to present clinical experiences of a third-level hospital (2009-2019) in PSD and compare these with adult spondylodiscitis (ASD). Of a total of 10 PSD patients, most of the infants presented with unspecific pain such as hip pain or a limping, misleading an adequate diagnosis of spine origin. Eight patients could be treated conservatively whereas surgery was performed in two cases with one case of tuberculous PSD (tPSD). The causative agent was detected in three of the patients. The diagnosis of PSD is often difficult since clinical symptoms are unspecific and causative pathogens often remain undetected. Nevertheless, empirical anti-infective therapy also seems to be effective. Based on recent studies, clinicians should be encouraged to keep the duration of anti-infective therapy in children short. Since comorbidities are not presented in PSD it is unclear which children suffer from PSD; thus, studies are necessary to identify predisposing factors for PSD. In our study, PSD differs from ASD in diagnostic and especially in therapeutic aspects. Therefore, specific guidelines for PSD would be desirable.
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PURPOSE: Closed reduction and subsequent spica casting is the gold standard for treatment of unstable or dislocated developmental dysplastic hips (DDHs). There are few data on mid-term results after treatment of DDH, especially on closed reduction. METHODS: Thirty-one consecutive patients with unstable or dislocated hips (n = 36) that were treated by fluoroscopic, contrast agent-supported closed reduction and spica casting were included and evaluated clinically and radiologically 2 and 5 years after treatment. RESULTS: After 2 and 5 years, there were no significant differences between healthy and successfully treated hips that were detectable with respect to acetabular coverage (AC) angle, center-edge angle, and clinical stability of the hip. There was a significant difference at the 2-year follow-up between healthy hips and hips that needed to undergo secondary open reduction surgery (n = 4) with respect to the AC angle (p < 0.001). CONCLUSION: Closed reduction in DDHs results in acceptable clinical and radiological results in the mid-term follow-up. It remains unclear why some patients with subsequent sonographically matured hips show secondary deterioration and recurrence of dysplasia.
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Background: Adequate assessment of spinal instability using the spinal instability neoplastic score (SINS) frequently guides surgical therapy in spinal epidural osseous metastases and subsequently influences neurological outcome. However, how to surgically manage 'impending instability' at SINS 7−12 most appropriately remains uncertain. This study aimed to evaluate the necessity of spinal instrumentation in patients with SINS 7−12 with regards to neurological outcome. Methods: We screened 683 patients with spinal epidural metastases treated at our interdisciplinary spine center. The preoperative SINS was assessed to determine spinal instability and neurological status was defined using the Frankel score. Patients were dichotomized according to being treated by instrumentation surgery and neurological outcomes were compared. Additionally, a subgroup analysis of groups with SINS of 7−9 and 10−12 was performed. Results: Of 331 patients with a SINS of 7−12, 76.1% underwent spinal instrumentation. Neurological outcome did not differ significantly between instrumented and non-instrumented patients (p = 0.612). Spinal instrumentation was performed more frequently in SINS 10−12 than in SINS 7−9 (p < 0.001). The subgroup analysis showed no significant differences in neurological outcome between instrumented and non-instrumented patients in either SINS 7−9 (p = 0.278) or SINS 10−12 (p = 0.577). Complications occurred more frequently in instrumented than in non-instrumented patients (p = 0.016). Conclusions: Our data suggest that a SINS of 7−12 alone might not warrant the increased surgical risks of additional spinal instrumentation.
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Cells within the tumor stroma are essential for tumor progression. In particular, cancer-associated fibroblasts (CAF) and CAF precursor cells (resident fibroblasts and mesenchymal stromal cells) are responsible for the formation of the extracellular matrix in tumor tissue. Consequently, CAFs directly and indirectly mediate inflammation, metastasis, immunomodulation, angiogenesis, and the development of tumor chemoresistance, which is orchestrated by complex intercellular cytokine-mediated crosstalk. CAFs represent a strategic target in antitumor therapy but their heterogeneity hinders effective treatment regimes. In-depth understanding of CAF subpopulations and knowledge of specific functions in tumor progression will ultimately result in more specific and effective cancer treatments. This review provides a detailed description of CAFs and CAF precursor cells and summarizes possible treatment strategies as well as molecular targets of these cells in antitumor therapies.
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PURPOSE: Vertebral osteomyelitis (VO) has a high mortality and leads to chronic pain and functional disability. Surgical treatment is often necessary. To date, little is known about the consequences of surgery on patient outcome. The aim of this study was to determine the quality of life (QoL) and mortality rates of surgically treated VO patients for a period of 2 years. METHODS: Patients with VO undergoing surgical treatment in a tertiary referral hospital from 2008 to 2015 were included prospectively. Data were collected before (T0) as well as 1 year (T1) and 2 years (T2) post-surgery. Within the European Spine Tango registry, prospective patient and QoL data were collected using validated outcome scores: Oswestry Disability Index, Short Form 36/EuroQol, Visual Analog Scale, and Core Outcome Measures Index. RESULTS: From 195 patients surgically treated for VO, QoL data were available from 136 patients at T0, 100 patients at T1, and 82 patients at T2, respectively. The 1- and 2-year mortality rates were 20% and 23%. Mainly all QoL outcome scores showed significant improvement at T1 and did not change significantly from T1 to T2. CONCLUSION: Surgical treatment of VO patients leads to significantly improved QoL. Nevertheless, QoL levels were below those of the general population. Our results underscore that spine disability questionnaires measuring QoL are mandatory to demonstrate comprehensively the severity of this entity. Our study confirms a high mortality and points out the role of VO as a potentially life-threatening condition.
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Osteomielite , Qualidade de Vida , Avaliação da Deficiência , Humanos , Osteomielite/cirurgia , Estudos Prospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Atraumatic hip pain in children is one of the most common symptoms with which pediatricians, orthopedists, and general practitioners are confronted, with an incidence of 148 cases per 100 000 persons per year. METHODS: This article is based on publications up to April 2019 that were retrieved by a selective search in the PubMed data- base, including case reports and reviews. RESULTS: Infants with fever often have purulent coxitis, which can be diagnosed by blood tests and ultrasonography. Toddlers and older children may suffer from painful restriction of motion of the hip joint, associated with limping (antalgic gait) or even the in- ability to walk. The main elements of the differential diagnosis in children aged 2-10 are coxitis fugax and idiopathic necrosis of the femoral head (Perthes disease). In children aged 10 and up, and in adolescents, slipped capital femoral epiphysis (SCFE) is typical. Bone tumors and rheumatic diseases must always be considered as well. The initial diagnostic steps on presentation of a child with restricted hip movement should be plain x-rays and joint ultrasonography for the detection of an effusion. Suspicion of a tumor is the main indication for tomographic imaging (computed tomography or magnetic resonance imaging). CONCLUSION: The underlying cause of hip pain in children should be diagnosed early to avoid adverse sequelae.
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Artralgia/etiologia , Articulação do Quadril , Adolescente , Criança , Pré-Escolar , Diagnóstico Diferencial , Humanos , Lactente , Literatura de Revisão como AssuntoRESUMO
BACKGROUND: Prognostic scores have been proposed to guide the treatment of patients with metastatic spine disease (MSD), but their accuracy and usefulness are controversial. The aim of this study was to evaluate seven such prognostic scoring systems. The following prognostic scores were compared: Tomita, Van der Linden (VDL), Bauer modified (BM), Oswestry Spinal Risk Index (OSRI), Tokuhashi original (T90), Tokuhashi revised (TR05), and modified Tokuhashi revised (TR17). METHODS: We retrospectively reviewed all our patients who underwent surgery for spinal metastases, February 2008-January 2015. We classified all 223 patients into the predicted survival-time categories of each of the 7 scoring systems and then tallied how often this was correct vis-à-vis the actual survival time. Accuracy was also assessed using receiver operating characteristic (ROC) analysis at 1, 3, and 12 months. RESULTS: The median (95% CI) survival of the 223 patients was 13.6 (7.9-19.3) months. A groupwise ROC analysis showed sufficient accuracy for 3-month survival only for TR17 (area under the curve [AUC] 0.71) and for 1-year survival for T90 (AUC 0.73), TR05 (AUC 0.76), TR17 (AUC 0.76), Tomita (AUC 0.77), and OSRI (AUC 0.71). A pointwise ROC score analysis showed poor prognostic ability for short-term survival (1 and 3 months) with sufficient accuracy for T90 (AUC 0.71), TR05 (AUC 0.71), TR17 (AUC 0.71), and the Tomita score (AUC 0.77) for 1-year survival. CONCLUSION: The TR17 was the only prognostic system with acceptable performance here. More sophisticated assessment tools are required to keep up with present and future changes in tumor diagnostics and treatment.
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Neoplasias Epidurais/patologia , Índice de Gravidade de Doença , Adulto , Idoso , Neoplasias Epidurais/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , PrognósticoRESUMO
BACKGROUND: Spinal metastases are being diagnosed more frequently because of increasing life expectancies and advances in the diagnosis and therapy of primary tumours. OBJECTIVE: This aim of this study was to assess the quality of life (QoL) and functional outcomes after surgical intervention for spinal metastases in a large cohort. METHODS: A single-centre, prospective, observational study was conducted from June 2016 to February 2018. Patients treated surgically for spinal metastasis were included. Primary endpoints were the Core Outcome Measure Index (COMI), Oswestry Disability Index (ODI), and QoL questionnaire (EuroQoL-5D) scores recorded preoperatively, 6 weeks postoperatively, and 3, 6, and 12 months postoperatively. RESULTS: Ninety-two patients (mean age, 62.7 ± 12.8 years) were included. The most frequent neoplasms were multiple myeloma (n= 18; 19.6%), lung cancer (n= 16; 17.4%), prostate cancer (n= 14; 15.2%), and breast cancer (n= 11; 12.0%). During the observation period, 44.6% of patients died. The COMI score improved significantly from preoperatively (mean, 7.1; 95% CI, 6.6-7.6) to 3 months (mean, 5.5; 95% CI, 4.8-6.2; p= 0.01) and 12 months (mean, 4.6; 95% CI, 3.7-5.5; p= 0.001) postoperatively. The ODI showed a significant improvement from preoperatively (mean, 52.9; 95% CI, 48.5-57.4) to 6 weeks (mean, 43.4; 95% CI, 37.1-49.6; p= 0.03), 3 months (mean, 37.0; 95% CI, 31.0-42.9) 6 months mean, 40.5; 95% CI, 34.2-46.8; p= 0.01), and 12 months (mean, 31.9; 95% CI, 24.8-39.1; p= 0.005) postoperatively. Improvements in the COMI at 6 weeks (p= 0.05), and 6 months (p= 0.05) postoperatively were not statistically significant. QoL improved from preoperatively to 6 weeks (mean, 0.48; 95% CI, 0.38-0.59; p= 0.002), 3 months (mean, 0.50; 95% CI, 0.38-0.61; p= 0.009), and 12 months (mean, 0.61; 95% CI, 0.51-0.71; p= 0.001) postoperatively. After 6 months, the difference was not significant (p= 0.08). CONCLUSION: Short-term and long-term improvements in functional outcomes and QoL were observed after surgical treatment of spinal metastases. Surgery is a good option for patients with an estimated life expectancy of more than 3 months.
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Vértebras Lombares/cirurgia , Qualidade de Vida , Neoplasias da Coluna Vertebral/secundário , Neoplasias da Coluna Vertebral/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Avaliação da Deficiência , Feminino , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Desempenho Físico Funcional , Complicações Pós-Operatórias/epidemiologia , Estudos Prospectivos , Fatores SexuaisRESUMO
The C-reactive protein (CRP) is still the conventional marker used to diagnose implant-associated infections (IAI) after orthopaedic surgery. However, the CRP level can lead to misdiagnosis since it is up-regulated not only during bacterial infection. In this prospective study, we evaluated the serum cytokine profile before (pre-OP) and after orthopaedic surgery (post-OP) as well as after confirmation of a developed infection (COI) to identify candidate biomarkers for diagnosis of IAI. Sera from 10 controls 7 to 1â¯days pre-OP and 0 to 22â¯days post-OP as well as from 5 patients who developed IAI 5 to 1â¯days pre-OP, 0 to 197â¯days post-OP and after COI were analyzed for 27 different cytokines using a multiplex cytokine assay. In addition to CRP, 14 cytokines IL-1ra, IL-4, IL-5, IL-6, IL-8, IL-12(p70), IL-13, IL-17, eotaxin, G-CSF, IFN-γ, IP-10, MCP-1, and MIP-1ß were significantly altered (Pâ¯≤â¯0.05) during the study although some differences were low-fold elevations compared to the pre-OP levels. IL-6 as well as IL-12(p70) were consistently elevated in infected patients. Surgery influenced cytokine production with some overlap of cytokines in both groups, implying that the use of cytokines is maximized when the cytokines are not or no longer affected by surgical trauma. To lend more robustness to the selection of candidate cytokines, in addition to the statistical differences, we applied a threshold cut-off of approximately 2-fold elevations when comparisons were made. This resulted in the selection of 8 cytokines, namely IL-6, IL-1ra, IL-8, IL-12(p70), eotaxin, IP-10, MCP-1, and MIP-1ß, which may be used in a multiplex assay for detection of IAI after surgery. Furthermore, IL-1ra and IL-8 may be used as prognostic cytokines prior to surgery. The present results imply that the use of cytokines may be a suitable alternative to CRP for IAI diagnosis.
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Citocinas/sangue , Procedimentos Ortopédicos/efeitos adversos , Infecções Relacionadas à Prótese/sangue , Infecções Relacionadas à Prótese/diagnóstico , Adulto , Idoso , Idoso de 80 Anos ou mais , Biomarcadores/sangue , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prognóstico , Estudos ProspectivosRESUMO
PURPOSE: International Standards Organization (ISO) 12189 and American Society for Testing and Materials F2624 are two standard material specification and test methods for spinal implant devices. The aim of this study was to assess whether the existing and required tests before market launch are sufficient. METHODS: In three prospective studies, patients were treated due to degenerative disease of the lumbar spine or spondylolisthesis with lumbar interbody fusion and dynamic stabilization of the cranial adjacent level. The CD HORIZON BalanC rod and S4 Dynamic rod were implanted in 45 and 11 patients, respectively. RESULTS: A fatigue fracture of the material of the topping off system has been found in five cases (11%) for the group fitted with the CD HORIZON BalanC rod. In the group using the S4 Dynamic rod group, a material failure of the dynamic part was demonstrated in seven patients (64%). All three studies were interrupted due to these results, and a report to the Federal Institute for Drugs and Medical Devices was generated. CONCLUSION: Spinal implants have to be checked by a notified body before market launch. The notified body verifies whether the implants fulfil the requirements of the current standards. These declared studies suggest that the current standards for the testing of load bearing capacity and stand ability of dynamic spine implants might be insufficient. Revised standards depicting sufficient deformation and load pattern have to be developed and counted as a requirement for the market launch of an implant. These slides can be retrieved under Electronic Supplementary Material.
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Vértebras Lombares/cirurgia , Teste de Materiais/normas , Próteses e Implantes , Falha de Prótese/etiologia , Doenças da Coluna Vertebral/cirurgia , Fusão Vertebral/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Espondilolistese/cirurgia , Suporte de CargaRESUMO
BACKGROUND: Equestrian vaulting is a sport, particularly popular among children and adolescents, in which gymnastic and dance routines are performed on horseback. Current data regarding injuries and thus, the risks of this sport, is meager and based only on retrospective studies. METHODS: In the current prospective study, 233 active members of a vaulting club were questioned monthly from November 2014 until October 2015. In addition to general information (training, competitions), the questionnaire collected the number of competitions, the competitive class, the discipline (single, team, Pas-de-Deux), and injuries (type, localization, treatment). RESULTS: There were 102 documented events resulting in 125 injuries, yielding an average 31.64 days of training lost. Each vaulter suffered an average 0.44 injuries per year. Frequency of injury was 2.15 injuries per 1000 training hours. Injuries occurred most often to the lower and upper extremities. Most common were bruises and muscle injuries. Injury risk increased with increasing age, number of falls from the horse, increasing competitive level, number of tournament entries and events (P=0.006), and previous injuries (P=0.010). CONCLUSIONS: Our study found that vaulting has a low risk of injury comparable to non-contact sports. The best focus for injury prevention strategies is on older vaulters at higher competitive levels performing more complex routines.
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Traumatismos em Atletas/epidemiologia , Cavalos , Acidentes por Quedas/estatística & dados numéricos , Adolescente , Adulto , Animais , Traumatismos em Atletas/prevenção & controle , Criança , Feminino , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Inquéritos e Questionários , Adulto JovemRESUMO
OBJECTIVE: The purpose of this study was to assess the radiologic and clinical outcomes after lumbar fusion intervention and to compare the established posterior lumbar interbody fusion (PLIF) technique and dynamic hybrid instrumentation (topping off). METHODS: In this prospective randomized trial, all patients who presented with degenerative changes to the lumbar spine (L2-S1) were included and randomized in 2 groups: patients who underwent the 360°-fusion procedure in PLIF (group 1: control group) and those patients who underwent fusion surgery with additional hybrid instrumentation (Dynesys-Transition-Optima [Zimmer Spine Inc., Denver, Colorado, USA]) cranial to the rigid fixed segment (group 2: intervention group). Patients' demographics were documented and follow-up visits were conducted after 6 weeks and then stepwise after 6 up to 36 months. Each follow-up visit included assessment of quality of life and pain using specific questionnaires (Core Outcome Measurements Index, Short-Form 36, and Oswestry Disability Index) as well as radiologic evaluation with the focus on the adjacent level alteration. RESULTS: Fifteen patients per group met the inclusion criteria, and after 36 months, the loss to follow-up was 20%. At the maximum follow-up time, the overall risk for adjacent segment degeneration was substantial (i.e., 24.14%), independent of the surgical procedure. Material failure was observed in 17.24%. Although no significant difference was observed between both groups, all patients presented with postoperative improvement regarding the clinical scores. CONCLUSIONS: The present study cannot support the safety of dynamic hybrid devices in those cases if the reduction of adjacent segment degeneration is the main target, especially regarding the reported implant failure rates and the similar clinical outcomes between the both groups.
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Vértebras Lombares/cirurgia , Fusão Vertebral/instrumentação , Estenose Espinal/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Degeneração do Disco Intervertebral/diagnóstico por imagem , Degeneração do Disco Intervertebral/cirurgia , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Estudos Prospectivos , Próteses e Implantes , Qualidade de Vida , Radiografia , Estenose Espinal/diagnóstico por imagem , Resultado do TratamentoRESUMO
BACKGROUND: Lower-limb endoprosthetic operations and spinal operations are among the more common types of orthopedic procedures. Postoperative woundhealing disturbances and infections can lead to longer periods of hospital stay and recovery as well as to higher morbidity and mortality. METHODS: 209 patients who had been judged to have an indication for a primary knee or hip endoprosthesis or for a primary spinal operation were included in this randomized trial (ClinicalTrials.gov: NCT01988818) over the period June 2014- February 2015. After randomization, patients in the intervention group were given a trial dressing (Mepilex-Border Post-Op) and those in the control group were given a conventional adhesive dressing (Cosmopor). The primary endpoint was blister formation. RESULTS: In the overall study population, only a single case of blister formation was seen. The affected patient belonged to the intervention group but was mistakenly given a control dressing and developed blisters on the 6th day after surgery. Dressings were changed less frequently in the intervention group, and this difference was statistically significant (p<0.001). The patients, nurses, and physicians all expressed greater satisfaction with the trial dressings than with the control dressings (p<0.001). CONCLUSION: The intervention group did not differ from the control group with respect to the primary endpoint, postoperative blister formation. The patients, nurses, and physicians all judged the dressing used in the intervention group more favorably than the conventional dressing.