Surgical interventions for treating hallux valgus and bunions.

BACKGROUND: Hallux valgus (lateral angulation of the great toe towards the lesser toes, commonly known as bunions) presents in 23% to 35% of the population. This condition leads to poor balance and increases the risk of falling, adding to the difficulty in fitting into shoes and pain. Conservative (non-surgical) interventions treating pain rather than curing deformity are usually first-line treatments. When surgery is indicated, the overall best surgical procedure is an ever-evolving topic of discussion. OBJECTIVES: To assess the benefits and harms of different types of surgery compared with placebo or sham surgery, no treatment, non-surgical treatments and other surgical interventions for adults with hallux valgus. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase and trial registries to 20 April 2023. We did not apply any language or publication restrictions. SELECTION CRITERIA: We included randomised controlled trials evaluating surgical interventions for treating hallux valgus compared to placebo surgery or sham surgery, no treatment, non-surgical treatment or other surgical interventions. The major outcomes were pain, function, quality of life, participant global assessment of treatment success, reoperation (treatment failure), adverse events and serious adverse events. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies for inclusion, extracted data, and assessed risk of bias and the certainty of evidence using GRADE. MAIN RESULTS: We included 25 studies involving 1597 participants with hallux valgus. All studies included adults and most were women. One study compared surgery (V-shaped osteotomy) with no treatment and with non-surgical treatment. Fifteen studies compared different surgical techniques, including a V-shaped osteotomy (Chevron osteotomy), to other types of osteotomy. Nine studies compared different simple osteotomy techniques to each other or to a mid-shaft Z-shaped osteotomy (Scarf osteotomy). Most trials were susceptible to bias: in particular, selection (80%), performance (88%), detection (96%) and selective reporting (64%) biases. Surgery versus no treatment Surgery may result in a clinically important reduction in pain. At 12 months, mean pain was 39 points (0 to 100 visual analogue scale, 100 = worst pain) in the no treatment group and 21 points in the surgery group (mean difference (MD) -18.00, 95% confidence interval (CI) -26.14 to -9.86; 1 study, 140 participants; low-certainty evidence). Evidence was downgraded for bias due to lack of blinding and imprecision. Surgery may result in a slight increase in function. At 12 months, mean function was 66 points (0 to 100 American Orthopedics Foot and Ankle Scale (AOFAS), 100 = best function) in the no treatment group and 75 points in the surgery group (MD 9.00, 95% CI 5.16 to 12.84; 1 study, 140 participants; low-certainty evidence). Evidence was downgraded for bias due to lack of blinding and imprecision. Surgery may result in little to no difference in quality of life. At 12 months, mean quality of life (0 to 100 on 15-dimension scale, 100 = higher quality of life) was 93 points in both groups (MD 0, 95% CI -2.12 to 2.12; 1 study, 140 participants; low-certainty evidence). Evidence was downgraded for bias due to lack of blinding and imprecision. Surgery may result in a slight increase in participant global assessment of treatment success. At 12 months, mean participant global assessment of treatment success was 61 points (0 to 100 visual analogue scale, 100 = completely satisfied) in the no treatment group and 80 points in the surgery group (MD 19.00, 95% CI 8.11 to 29.89; 1 study, 140 participants; low-certainty evidence). Evidence was downgraded for bias due to lack of blinding and imprecision. Surgery may have little effect on reoperation (relative effect was not estimable), adverse events (risk ratio (RR) 8.75, 95% CI 0.48 to 159.53; 1 study, 140 participants; very low-certainty evidence), and serious adverse events (relative effect was not estimable), but we are uncertain. Surgery versus non-surgical treatment Surgery may result in a clinically important reduction in pain; a slight increase in function and participant global assessment of treatment success; and little to no difference in quality of life (1 study, 140 participants; low-certainty evidence). We are uncertain about the effect on reoperation, adverse events and serious adverse events (1 study, 140 participants; very low-certainty evidence). Complex versus simple osteotomies Complex osteotomies probably result in little to no difference in pain compared with simple osteotomies (7 studies, 414 participants; moderate-certainty evidence). Complex osteotomies may increase reoperation (7 studies, 461 participants; low-certainty evidence), and may result in little to no difference in participant global assessment of treatment success (8 studies, 462 participants; low-certainty evidence) and serious adverse events (12 studies; data not pooled; low-certainty evidence). We are uncertain about the effect of complex osteotomies on function and adverse events (very low-certainty evidence). No study reported quality of life. AUTHORS' CONCLUSIONS: There were no trials comparing surgery to placebo or sham. Surgery may result in a clinically important reduction in pain when compared to no treatment or non-surgical treatment. Surgery may also result in a slight increase in function and participant global assessment of treatment success compared to no treatment or non-surgical treatment. There may be little to no difference in quality of life between surgery and no treatment or non-surgical treatment. We are uncertain about the effect of surgery on reoperation (treatment failure), adverse events or serious adverse events, when compared to no treatment or non-surgical treatment. Complex and simple osteotomies demonstrated similar results for pain. Complex osteotomies may increase reoperation (treatment failure) and may result in little to no difference in participant global assessment of treatment success and serious adverse events compared to simple osteotomies. We are uncertain about the effect of complex osteotomies on function, quality of life and adverse events.

Bacterial identification in herniated intervertebral discs: a prospective cohort study.

BACKGROUND CONTEXT: Reports of Cutibacterium acnes isolated in cultures of intervertebral disc samples suggest it as possibly responsible for inflammatory conditions causing Modic changes on spinal magnetic resonance imaging (MRI). PURPOSE: Our objective was to investigate the prevalence of C. acnes in samples of intervertebral disc of patients with lumbar disc herniation; to investigate prognostic factors and the relationship of Modic changes with infection 1 year after microdiscectomy. STUDY DESIGN: Prospective cohort study. PATIENT SAMPLE: In this single-center study, patients consecutively operated on for disc herniation had samples of the disc, multifidus muscle and ligamentum flavum (as an indication of contamination) extracted for culture. OUTCOME MEASURES: Age, sex, alcohol and tobacco consumption, body mass index; function, pain, and Modic chances in MRI before surgery and MRI 1 year later; rate of disc, muscle and ligament infection (primary outcome); diabetes and corticoid use (confoundings). METHODS: The protruded disc, muscle and ligament samples were sent for culture analysis in up to 30 minutes. A subsample of 17 patients underwent next-generation sequencing (NGS) molecular analysis too. We performed descriptive analysis and comparison of groups of patients with and without infection or contamination using Student's t, Mann-Whitney, chi-square, or Fisher's exact tests as appropriate, and pre- and postsurgical comparisons with the Wilcoxon test. RESULTS: From January 2018 to September 2019, 112 patients underwent open lumbar microdiscectomy, 67 (59.8%) men. Cultures showed 7 (6.3%) positive cases in the disc (2 with C. acnes), 3 (2.7%) in the ligament, and 12 (10, 7%) in muscle. No evidence of a difference in Modic alterations pre- or postoperatively was found between patients with and without positive culture 1 year after surgery. No association was found between culture positivity and functional or pain differences either. NGS results were all negative for C. acnes. CONCLUSIONS: We identified infective bacterial presence in the herniated disc in less than 2% of patients with disc herniation. C. acnes was not identified in any disc microbiome analysis. No significant association was observed between positivity for tissue infection and any clinical prognostic factor.

Robot-assisted knee arthroplasty: Analyzing the learning curve and initial institutional experience.

Robot-assisted total knee arthroplasty (rTKA) involves a learning curve for orthopedic surgeons. The aim of the present study was to assess the surgical times of rTKA procedures performed by initial stage and proficiency stage surgeons in comparison with times of conventional total knee arthroplasty (cTKA). The results reveal that the learning curve for rTKA varies considerable between surgeons, suggesting that the skill and aptitude of the individual to adapt to the robotic system play key roles in the learning process. Proficiency stage surgeons were able to reduce rTKA surgical times to levels comparable with those of conventional surgeries after performing approximately 30 to 40 robotic procedures. Ongoing research has shown promising outcomes in terms of improved clinical results and reduced complications following the application of advanced robotic technology to total knee arthroplasty.

Cost-effectiveness of a second opinion program on spine surgeries: an economic analysis.

BACKGROUND: In this study we proposed a new strategy to measure cost-effectiveness of second opinion program on spine surgery, using as measure of effectiveness the minimal important change (MIC) in the quality of life reported by patients, including the satisfaction questionnaire regarding the treatment and direct medical costs. METHODS: Retrospective analysis of patients with prior indication for spine surgery included in a second opinion program during May 2011 to May 2019. Treatment costs and outcomes were compared considering each patients' recommended treatment before and after the second opinion. Costs were measured under the perspective of the hospital, including hospital stay, surgical room, physician and staff fees and other costs related to hospitalization when surgery was performed and physiotherapy or injection costs when a conservative treatment was recommended. Reoperation costs were also included. For comparison analysis, we used data based on our clinical practice, using data from patients who underwent the same type of surgical procedure as recommended by the first referral. The measure of effectiveness was the percentage of patients who achieved the MIC in quality of life measured by the EQ-5D-3 L 2 years after starting treatment. An incremental cost-effectiveness ratio (ICER) was calculated. RESULTS: Based upon the assessment of 1,088 patients that completed the entire second opinion process, conservative management was recommended for 662 (60.8%) patients; 49 (4.5%) were recommended to injection and 377 (34.7%) to surgery. Complex spine surgery, as arthrodesis, was recommended by second opinion in only 3.7% of cases. The program resulted in financial savings of -$6,705 per patient associated with appropriate treatment indication, with an incremental effectiveness of 0.077 patients achieving MIC when compared to the first referral, resulting in an ICER of $-87,066 per additional patient achieving the MIC, ranging between $-273,016 and $-41,832. CONCLUSION: After 2 years of treatment, the second opinion program demonstrated the potential for cost-offsets associated with improved quality of life.

Development and Validation of the 17-Point Brazilian Portuguese Translated Version of the Modified Japanese Orthopedic Association Score (mJOA-BR17).

BACKGROUND: Cervical spondylotic myelopathy (CSM) is the most common degenerative dysfunction of the spinal cord in the cervical spine in patients older than 55 years. The Japanese Orthopedic Association developed a scoring system to quantify clinical impairment of CSM patients, allocate them according to the degree of impairment, and suggest best timing for surgery. The original version evaluates the upper limb motor function through the ability of feeding with chopsticks, which are not intrinsic in western populations. To compare severity and treatment improvement of any diseases, it is preferable to have modified and translated versions of questionnaires and scores closest to the original ones. The authors present a prospective cohort study to validate the 17-point Brazilian Portuguese translated version of the modified Japanese Orthopedic Association (mJOA-BR17) survey. METHODS: Patients with CSM (n = 36) were allocated to the disease group, while age- and sex-matched healthy volunteers (n = 34) were recruited for the control group. Comparison of statistical analysis of mJOA-BR17 domains for each group was established. After the translation and adaptation of mJOA-BR17, the validation was made through application to the 2 groups. RESULTS: There were statistical differences between groups in total mJOA-BR17 score (CSM, 14.14 ± 2.92; control, 16.68 ± 0.59: P < 0.001), lower limbs motor function (CSM, 3.25 ± 1.02; control, 3.91 ± 0.29: P < 0.001), upper limbs sensory function (CSM, 1.17 ± 0.81; control, 1.86 ± 0.36: P < 0.001), lower limbs sensory function (CSM, 1.62 ± 0.64; control, 2.0 ± 0.0: P < 0.001), and bladder function (CSM, 2.69 ± 0.52; control, 2.97 ± 0.17: P = 0.005). The receiver operating characteristic curve was 0.81, indicating usefulness of the mJOA-BR17 score to identify patients with CSM from healthy controls. CONCLUSIONS: The mJOA-BR17 demonstrated similarity, applicability, and good understanding in comparison to the English-modified version of 17-point JOA score for CSM, becoming a valuable tool to quantify and differentiate CSM patients from healthy individuals.

Assessment of the Risk Factors Related to the Length of Hospital Stay and Postoperative Complications in Patients Undergoing Primary Total Knee Arthroplasty.

Objective To assess the risk factors involving longer hospital stays and early postoperative complications (first 30 days after surgery) in patients undergoing total knee arthroplasty (TKA). Materials and Methods A cross-sectional study was conducted with collection of data of patients who underwent TKA in a private hospital between 2015 and 2019. The following data were collected: age, gender, body mass index, and clinical comorbidities. We also collected intraoperative data such as the grade on the classification of the American Society of Anesthesiologists (ASA), the duration of the surgery, the length of stay, the postoperative complications, and readmission within 30 days. Statistical models were used to investigate the possible risk factors associated with longer hospital stays and postoperative complications. Results There was evidence of an increase in the length of hospital stay in older patients, with higher grades on the ASA classification or who suffered postoperative complications. For each increase in 1 year of age, we expect the length of stay to be multiplied by 1.008 (95% confidence interval [95%CI]: 1.004 to 1.012; p < 0,001). In patients who were ASA grade III, the time is expected to be multiplied by 1.297 (95%CI: 1.083 to 1.554; p = 0,005) when compared with grade-I patients. In patients who suffered postoperative complications, the time is expected to be multiplied by 1.505 (95%CI: 1.332 to 1.700; p < 0.001) compared with patients without complications. Conclusion The present study demonstrated that, in patients who underwent primary TKA, preoperative characteristics such as older age and ASA grade ≥ III, as well as the development of postoperative complications, independently predict the increase in the length of hospital stay.

Assessment of the Risk Factors Related to the Length of Hospital Stay and Postoperative Complications in Patients Undergoing Primary Total Knee Arthroplasty / Avaliação dos fatores de risco relacionados ao tempo de internação e às complicações pós-operatórias em pacientes submetidos a artroplastia total primária do joelho

Abstract Objective To assess the risk factors involving longer hospital stays and early postoperative complications (first 30 days after surgery) in patients undergoing total knee arthroplasty (TKA). Materials and Methods Across-sectional study was conducted with collection of data of patients who underwent TKA in a private hospital between 2015 and 2019. The following data were collected: age, gender, body mass index, and clinical comorbid-ities. We also collected intraoperative data such as the grade on the classification of the American Society of Anesthesiologists (ASA), the duration of the surgery, the length of stay, the postoperative complications, and readmission within 30 days. Statistical models were used to investigate the possible risk factors associated with longer hospital stays and postoperative complications. Results There was evidence of an increase in the length of hospital stay in older patients, with higher grades on the ASA classification or who suffered postoperative complications. For each increase in 1 year of age, we expect the length of stay to be multiplied by 1.008 (95% confidence interval [95%CI]: 1.004 to 1.012; p < 0,001). In patients who were ASA grade III, the time is expected to be multiplied by 1.297 (95%CI: 1.083 to 1.554; p = 0,005) when compared with grade-I patients. In patients who suffered postoperative complications, the time is expected to be multiplied by 1.505 (95%CI: 1.332 to 1.700; p < 0.001) compared with patients without complications. Conclusion The present study demonstrated that, in patients who underwent primary TKA, preoperative characteristics such as older age and ASA grade > III, as well as the development of postoperative complications, independently predict the increase in the length of hospital stay.

Resumo Objetivo Avaliar os fatores de risco relacionados a um tempo de internação mais longo e às complicações pós-operatórias precoces (primeiros 30 dias após a cirurgia) em pacientes submetidos a artroplastia total do joelho (ATJ). Materiais e Métodos Este é um estudo transversal com coleta de dados de pacientes submetidos a ATJ em um hospital privado entre 2015 e 2019. Os seguintes dados foram coletados: idade, gênero, índice de massa corporal, e comorbidades clínicas. Também coletamos dados intraoperatórios, como o grau na classificação da American Society of Anesthesiologists (ASA) e a duração da cirurgia, além do tempo de internação, as complicações pós-operatórias, e a readmissão em 30 dias. Os possíveis fatores de risco associados a um tempo de internação mais longo e às taxas de complicações pós-operatórias foram investigados por meio de modelos estatísticos. Resultados Os pacientes mais velhos, com graus mais elevados na classificação da ASA ou que sofreram complicações pós-operatórias, ficaram internados por mais tempo. Para cada aumento em um ano de idade, esperamos que o tempo de internação seja multiplicado por 1,008 (intervalo de confiança de 95% [IC95%]: 1,004 a 1,012; p < 0,001). Em pacientes de grau III na classificação da ASA, espera-se que o tempo seja multiplicado por 1,297 (IC95%: 1,083 a 1,554; p = 0,005) em comparação com pacientes de grau I. Em pacientes com complicações pós-operatórias, espera-se que o tempo seja multiplicado por 1,505 (IC95%: 1,332 a 1,700; p < 0,001) em comparação com pacientes sem complicações. Conclusão Este estudo demonstrou que, em pacientes submetidos a ATJ primária, características pré-operatórias, como idade avançada e grau ≥ III na classificação da ASA, e o desenvolvimento de complicações pós-operatórias predizem o aumento do tempo de internação hospitalar de forma independente.

Quality of Life and Satisfaction in Patients Above and Under 65 Years Old Submitted to Total Knee Arthroplasty.

Objective To compare the level of quality of life and satisfaction after two years of total knee arthroplasties between individuals above and below 65 years of age and to identify predictor factors of poor clinical outcome and low level of satisfaction in patients undergoing arthroplasty. Methods This is a retrospective cohort with data from patients diagnosed with knee osteoarthritis submitted to primary total knee arthroplasty from 2014 to 2018 ( n = 190). Clinical outcomes were assessed using the following scores: visual analog scale (VAS) of pain, EQ-5D-3L and EUROQOL-VAS (quality of life scales), patient satisfaction level, and functional scale of the Knee Injury and Osteoarthritis Outcome Score (KOOS), collected through a questionnaire applied preoperatively, as well as 1, 3, 12 and 24 months after surgery. Results Patients < 65 years old presented significantly lower values (clinical worsening) in KOOS-pain and KOOS-symptoms. There are no differences in the principal clinical scores that assess pain, function, and quality of life after the procedure, as well as in the rate of satisfaction with the procedure, among patients < 65 years old when compared with patients ≥ 65 years old. It was also observed that patients who were not satisfied with the procedure in the 24-month evaluation presented clinical results in some analyzed scores (KOOS-pain and EQ-VAS) similar to patients who declared themselves satisfied. Conclusion Scores that assess pain, function, quality of life, as well as satisfaction rate are similar between patients < 65 years old and those ≥ 65 years old.

Quality of Life and Satisfaction in Patients Above and Under 65 Years Old Submitted to Total Knee Arthroplasty / Qualidade de vida e satisfação de pacientes com idade superior ou inferior a 65 anos submetidos a artroplastia total de joelho

Abstract Objective To compare the level of quality of life and satisfaction after two years of total knee arthroplasties between individuals above and below 65 years of age and to identify predictor factors of poor clinical outcome and low level of satisfaction in patients undergoing arthroplasty. Methods This is a retrospective cohort with data from patients diagnosed with knee osteoarthritis submitted to primary total knee arthroplasty from 2014 to 2018 (n= 190). Clinical outcomes were assessed using the following scores: visual analog scale (VAS) of pain, EQ-5D-3L and EUROQOL-VAS (quality of life scales), patient satisfaction level, and functional scale of the Knee Injury and Osteoarthritis Outcome Score (KOOS), collected through a questionnaire applied preoperatively, as well as 1, 3, 12 and 24 months after surgery. Results Patients < 65 years old presented significantly lower values (clinical worsening) in KOOS-pain and KOOS-symptoms. There are no differences in the principal clinical scores that assess pain, function, and quality of life after the procedure, as well as in the rate of satisfaction with the procedure, among patients < 65 years old when compared with patients ≥ 65 years old. It was also observed that patients who were not satisfied with the procedure in the 24-month evaluation presented clinical results in some analyzed scores (KOOS-pain and EQ-VAS) similar to patients who declared themselves satisfied. Conclusion Scores that assess pain, function, quality of life, as well as satisfaction rate are similar between patients < 65 years old and those ≥ 65 years old.

Resumo Objetivo Comparar a qualidade de vida e satisfação 2 anos após a artroplastia total de joelho em indivíduos com idade ≥ e < 65 anos e identificar fatores preditivos de pior evolução clínica e baixo nível de satisfação nestes pacientes. Métodos Trata-se de uma coorte retrospectiva de dados de pacientes com diagnóstico de osteoartrite de joelho submetidos a artroplastia total primária de joelho entre 2014 e 2018 (n= 190). Os resultados clínicos foram avaliados de acordo com os seguintes escores: escala visual analógica (EVA) de dor, EQ-5D-3L e EUROQOL-VAS (escalas de qualidade de vida), nível de satisfação do paciente e escala funcional do Knee Injury and Osteoarthritis Outcome Score (KOOS, na sigla em inglês). Estes dados foram coletados por meio de questionário aplicado no período pré-operatório e 1, 3, 12 e 24 meses após a cirurgia. Resultados Os pacientes < 65 anos apresentaram valores significativamente menores (piora clínica) nas escalas KOOS-dor e KOOS-sintomas. Não houve diferenças nas principais pontuações clínicas de dor, função e qualidade de vida após o procedimento, nem no índice de satisfação com a cirurgia, entre pacientes < 65 anos em comparação com aqueles ≥ 65 anos. Observamos também que os pacientes não satisfeitos com o procedimento à avaliação de 24 meses apresentaram resultados clínicos em alguns escores analisados (KOOS-dor e EQ-VAS) semelhantes aos dos pacientes que se declararam satisfeitos. Conclusão Os escores que avaliam dor, função, qualidade de vida e índice de satisfação são semelhantes entre os pacientes < 65 anos e aqueles ≥ 65 anos.

How Does Platelet-Rich Plasma Compare Clinically to Other Therapies in the Treatment of Knee Osteoarthritis? A Systematic Review and Meta-analysis.

BACKGROUND: There has been an increase in interest in the use of biological therapies in orthopaedic conditions such as knee osteoarthritis. Platelet-rich plasma (PRP) is one of these therapies, but it still lacks consistent results. PURPOSE: To evaluate the effects (benefits and harms) of PRP intra-articular injection compared with other nonsurgical methods for the treatment of knee osteoarthritis. STUDY DESIGN: Systematic review and meta-analysis of randomized and quasi-randomized controlled trials; Level of evidence, 2. METHODS: Three electronic databases were searched to identify relevant studies published before January 2021. The primary outcomes were pain, function, and failure of treatment. Risks of bias of all trials were assessed using a Cochrane risk of bias tool. The Grading of Recommendations Assessment, Development and Evaluation System was used to assess the quality of evidence of included studies. RESULTS: A total of 40 studies with 3035 participants were included. Analysis of this review focused on comparing PRP with hyaluronic acid, corticosteroid, and saline, as we believe they are the most relevant comparisons with the most studies available. At 6-month follow-up, PRP was as effective as and in some studies more effective than other therapies regarding pain, function, and stiffness. However, current evidence is of low or very low quality and is based on trials with high risk of bias and great heterogeneity among them. No significant difference among treatments was found concerning major adverse events and treatment failure. CONCLUSION: Although studies suggest that PRP may be more effective than or at least as effective as other modalities of nonsurgical treatment for knee osteoarthritis in terms of pain, function, and adverse events, serious limitations and methodological flaws are considerable in the current literature. Therefore, the authors are not able to make recommendations for clinical practice regarding PRP for knee osteoarthritis.

Hydroxychloroquine for treatment of COVID-19 patients: a systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: We performed a systematic review of the literature and meta-analysis on the efficacy and safety of hydroxychloroquine to treat COVID-19 patients. METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, and LILACS (January 2019 to March 2021) for patients aged 18 years or older, who had COVID-19 and were treated with hydroxychloroquine versus placebo or standard of care. We also searched the WHO Clinical Trials Registry for ongoing and recently completed studies, and the reference lists of selected articles and reviews for possible relevant studies, with no restrictions regarding language or publication status. Random-effects models were used to obtain pooled mean differences of treatment effect on mortality, and serious adverse effects between hydroxychloroquine and the Control Group (standard of care or placebo); heterogeneity was assessed using the I2 and the Cochran´s Q statistic. RESULTS: Nine studies met the inclusion criteria and were included in the meta-analysis. There was no significant difference in mortality rate between patients treated with hydroxychloroquine compared to standard of care or placebo (16.7% versus 18.5%; pooled risk ratio 1.09; 95% confidence interval: 0.99-1.19). Also, the rate of serious adverse effects was similar between both Groups, Hydroxychloroquine and Control (3.7% versus 2.9%; pooled risk ratio 1.22; 95% confidence interval: 0.76-1.96). CONCLUSION: Hydroxychloroquine is not efficacious in reducing mortality of COVID-19 patients. PROSPERO DATABASE REGISTRATION: (www.crd.york.ac.uk/prospero) under number CRD42020197070.

TOTAL HIP ARTHROPLASTY IN THE PUBLIC HEALTH SYSTEM OF SÃO PAULO: COMPARING TYPES OF FIXATION.

Brazil lacks registries on the prevalence of primary total hip arthroplasty (THA) fixation methods. Objective: (i) to describe the demographic profile of patients who underwent THA in the public health system of the municipality of São Paulo during the last 12 years and (ii) to compare fixation methods regarding costs, hospital stay length, and death rates. Methods: This is an ecological study conducted with data available on TabNet, a platform belonging to DATASUS. Public data (from the government health system) on THA procedures performed in São Paulo from 2008 to 2019 were extracted. Gender, age, city region, THA fixation method, number of surgeries, costs, hospital stay length, and death rates were analyzed. Results: We analyzed 7,673 THA, of which 6220 (81%) were performed via cementless/hybrid fixation and 1453 (19%), via the cemented technique. Cementless/hybrid fixation had a higher cost (US$ 495.27) than the cemented one (p < 0.001). Nevertheless, hospital stay length was 0.87 days longer for cemented fixation than the cementless/hybrid one. We found no significant difference in death rates between THA fixation methods. Conclusion: THA cementless/hybrid fixation is prevalent in the municipality of São Paulo, which had higher total costs and shorter hospitalizations than cemented fixation. We found no difference between THA fixation methods and death rates. Level of Evidence IV, Case Series.

No Brasil, não há registros da prevalência do tipo de fixação da artroplastia total de quadril (ATQ). Objetivo: (i) Descrever perfil demográfico de pacientes submetidos à ATQ no Sistema Único de Saúde de São Paulo durante os últimos doze anos; e (ii) comparar as técnicas de fixação de ATQ quanto aos custos, tempo de internação (TI) e taxa de óbito. Métodos: Estudo ecológico, com dados disponíveis na TabNet do DATASUS. Dados públicos de procedimentos de ATQ eletivos realizados em São Paulo de 2008 a 2019 foram extraídos. Foram analisados: sexo, idade, região municipal, método de fixação em ATQ, número de cirurgias, custo, tempo de internação e óbitos. Resultados: Foram analisadas 7.673 ATQs, sendo 6.220 (81%) não-cimentada/híbridas e 1.453 (19%) cimentadas. A fixação não-cimentada/híbrida teve custo maior em US$ 495,27 do que a cimentada (p < 0,001). Entretanto, TI foi 0,87 dia mais longo na fixação cimentada. Não houve diferença significativa nas taxas de óbito entre os métodos de fixação. Conclusão: A fixação não-cimentada/híbrida na ATQ é prevalente em São Paulo, e apresentou maior custo total, porém menor tempo de internação do que a fixação cimentada. Não houve diferença entre o método de fixação em ATQ e a taxa de óbito. Nível de Evidência IV, Série de Casos.

Physical exercise as a therapeutic approach for adults with insomnia: systematic review and meta-analysis.

OBJECTIVE: To systematically review the effects (benefits and harms) of different types of physical exercise on insomnia outcomes in adult populations with no mood disorders. Objective and subjective sleep outcomes and related mismatches were analyzed. METHODS: Systematic review and meta-analysis. Quality of evidence was also examined. RESULTS: Six studies including 295 participants with insomnia diagnosis were selected. Yoga, Tai Chi, resistance exercise and aerobic exercise were used in protocols with different duration, intensity and frequency. Studies involved different populations, including inactive or sedentary individuals, older adults and postmenopausal women. Physical exercise improved subjective sleep quality (very low quality of evidence) and reduced insomnia severity (high quality of evidence). CONCLUSION: Findings suggest individualized physical exercise must be addressed to design optimal protocols, with standardized type, duration, intensity, and frequency. For the time being, physical exercise may be considered an alternative and/or ancillary therapeutic modality for patients diagnosed with insomnia. Physical exercise can be used to improve subjective complaints, but not objective sleep outcomes.

Matrix-assisted autologous chondrocyte transplantation for treatment of focal chondral lesions in the knee: the Hospital Israelita Albert Einstein experience.

OBJECTIVE: Phase 1 clinical trial to determine feasibility, safety, and efficacy of a new advanced cell therapy product for treatment of knee articular cartilage injuries. METHODS: Three participants with knee focal chondral lesions were included, with no signs of osteoarthritis. Chondrocytes were obtained through knee arthroscopy, cultured in collagen membrane for 3 weeks at the laboratory, subjected to tests to release the cell therapy product, and implanted. All patients underwent a specific 3-month rehabilitation protocol, followed by assessments using functional and imaging scales. The main outcome was the incidence of severe adverse events. RESULTS: Three participants were included and completed the 2-year follow-up. There was one severe adverse event, venous thrombosis of distal leg veins, which was no associated with therapy, was treated and left no sequelae. The clinical and radiological scales showed improvement in the three cases. CONCLUSION: The preliminary results, obtained with the described methodology, allow concluding that this product of advanced cell therapy is safe and feasible. ReBEC platform registration number: RBR-6fgy76.

Quality assessment of systematic reviews of surgical treatment of cervical spine degenerative diseases: an overview.

OBJECTIVE: To gather all systematic reviews of surgical treatment of degenerative cervical diseases and assess their quality, conclusions and outcomes. METHODS: A literature search for systematic reviews of surgical treatment of degenerative cervical diseases was conducted. Studies should have at least one surgical procedure as an intervention. Included studies were assessed for quality through Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) and Assessment of Multiple Systematic Reviews (AMSTAR) questionnaires. Quality of studies was rated accordingly to their final score as very poor (<30%), poor (30%-50%), fair (50%-70%), good (70%-90%), and excellent (>90%). If an article reported a conclusion addressing its primary objective with supportive statistical evidence for it, they were deemed to have an evidence-based conclusion. RESULTS: A total of 65 systematic reviews were included. According to AMSTAR and PRISMA, 1.5% to 6.2% of studies were rated as excellent, while good studies counted for 21.5% to 47.7%. According to AMSTAR, most studies were of fair quality (46.2%), and 6.2% of very poor quality. Mean PRISMA score was 70.2%, meaning studies of good quality. For both tools, performing a meta-analysis significantly increased studies scores and quality. Cervical spondylosis studies reached highest scores among diseases analyzed. Authors stated conclusions for interventions compared in 70.7% of studies, and only two of them were not supported by statistical evidence. CONCLUSION: Systematic reviews of surgical treatment of cervical degenerative diseases present "fair" to "good" quality in their majority, and most of the reported conclusions are supported by statistical evidence. Including a meta-analysis significantly increases the quality of a systematic review.

Clinical outcome analysis in surgical patients enrolled in a Second Opinion Program in spine surgery.

OBJECTIVE: To analyze pain, functional capacity, quality of life, anxiety and depression outcomes in patients undergoing lumbar spine surgery following use of the Second Opinion Program, and to present disagreements regarding diagnoses and therapeutic indications between the first and second opinions. METHODS: A prospective, observational cohort study with 100 patients enrolled in the Second Opinion Program who underwent lumbar spine surgery. Questionnaires addressing pain intensity, level of disability, quality of life, anxiety and depression were applied prior to and within 1, 3, 6 and 12 months of surgery. Descriptive and comparative statistical analyses were performed. The following clinical outcomes were analyzed: pain intensity, level of disability, quality of life, anxiety, and depression. RESULTS: In this sample, 88% and 12% out of 100 patients were submitted to lumbar decompression and arthrodesis, respectively. Patients reported improvements in function, pain intensity, and quality of life factors following surgery and were able to attain the minimal clinically important difference relative to the preoperative period. Agreement between the first and second opinions was observed in 44% of diagnoses, and in 27% of therapeutic indications. CONCLUSION: Patients had favorable postoperative outcomes regarding pain, disability, and quality of life. These findings and the high rates of diagnostic and therapeutic indication disagreements corroborate the need of a second opinion in cases of spine disease with surgical indications.

Preoperative Home Care Can Be One of the Factors Affecting the Length of Hospital Stay in Patients Undergoing Total Hip Arthroplasty.

PURPOSE: To assess the importance of home nursing care on the functional outcome, quality of life, and length of stay of patients who underwent total hip arthroplasty. METHODS: This was a retrospective cross-sectional study including patients who underwent surgery from February 2011 to December 2016. Patients were analyzed in two groups: with home care (received nursing care) and without home care. The analyzed outcomes were quality of life, functional outcome, and length of hospital stay. Total follow-up with questionnaires was 24 months. RESULTS: A total of 244 patients (143 with home care and 101 without home care) were analyzed. No significant differences were found regarding the mean age (p = 0.125), gender distribution (p = 0.449) and BMI (p = 0.548) between the two groups. There was also no significant difference regarding functional outcome (p = 0.107) and quality of life (p = 0.848), measured by validated tools. However, the median of length of hospital stays in the home care group was lower in 1 day compared to without home care group (p < 0.001). CONCLUSION: The home nursing care did not influence the functional outcome or quality of life of the patients, but there was a decrease in the length of hospital stay in the group that received preoperative nursing care.

Minimally invasive swine spine surgery training: technical aspects, benefits, and anatomical limitations.

OBJECTIVE: To describe the technical specificities and feasibility of simulation of minimally invasive spine surgery in live pigs, as well as similarities and differences in comparison to surgery in humans. METHODS: A total of 22 Large White class swine models, weighing between 60 and 80kg, were submitted to surgical simulations, performed during theoretical-practical courses for training surgical techniques (microsurgical and endoscopic lumbar decompression; percutaneous pedicular instrumentation; lateral access to the thoracic spine, and anterior and retroperitoneal to the lumbar spine, and management of complications) by 86 spine surgeons. For each surgical technique, porcine anatomy (similarities and differences in relation to human anatomy), access route, and dimensions of the instruments and implants used were evaluated. Thus, the authors describe the feasibility of each operative simulation, as well as suggestions to optimize training. Study results are descriptive, with figures and drawings. RESULTS: Neural decompression surgeries (microsurgeries and endoscopic) and pedicular instrumentation presented higher similarities to surgery on humans. On the other hand, intradiscal procedures had limitations due to the narrow disc space in swines. We were able to simulate situations of surgical trauma in surgical complication scenarios, such as cerebrospinal fluid fistulas and excessive bleeding, with comparable realism to surgery on humans. CONCLUSION: A porcine model for simulation of minimally invasive spinal surgical techniques had similarities with surgery on humans, and is therefore feasible for surgeon training.

Next-generation sequencing (NGS) to determine microbiome of herniated intervertebral disc.

BACKGROUND CONTEXT: There is apparent causality between chronic infection of the intervertebral disc and its degenerative process. Although disc is considered a sterile tissue, collected samples of uninfected patients sent to culture testing resulted positive. PURPOSE: The purpose of this study was to analyze the microbiome of the intervertebral disc by using and validating the next-generation sequencing (NGS) molecular test, controlled with tissue culture and clinical presentation of patients. STUDY DESIGN/SETTING: Prospective study of consecutive patients in a hospital. PATIENT SAMPLE: Patients with lumbar disc herniation undergoing open microdiscectomy aging 18 to 65 years. OUTCOME MEASURES: NGS, tissue culture METHODS: Subjects undergoing open decompression surgery for lumbar disc herniation were consecutively included and clinically followed for one year. Three samples of the excised herniated disc fragment were sent to tissue culture and another sample of the disc was sent to NGS test for microbiome analysis. Control samples of the ligamentum flavum and deep muscle were collected and sent to culture. RESULTS: A total of 17 patients were included. All patients presented negative cultures of the removed disc samples, as well as negative cultures of muscle and yellow ligament. None of the patients evolved to clinical infection one year after surgery, nor presented significant alteration of laboratory markers. NGS mapped a mean of 14,645 (range 6,540 to 27,176) DNA sequences for each disc sample of each patient. There were a total of 45 different bacteria genera remnants with different amount of DNA sequences detected. There was a mean of 8 (range 3-17) different bacterial elements in each sample of intervertebral disc. Three bacteria were present in all disc samples (Herbaspirillum, Ralstonia, and Burkolderia). Although there were a considerable mean number of bacterial sequences mapped in each disc sample, the amount of sequences related to bacteria was low. Cutibacterium acnes elements was not found in any disc microbiome analysis. CONCLUSIONS: NGS has been proven to adequately determine bacterial DNA presence within the intervertebral disc. C. acnes was not isolated in culture neither in microbiome analysis of patients with lumbar disc herniation. We cannot confirm disc sterility since, even if it does not cause infection, there is bacterial or remnant DNA in herniated discs.

Total hip arthroplasty in the public health system of são paulo: comparing types of fixation / Artroplastia total de quadril no sistema público de são paulo: comparando os tipos de fixação

ABSTRACT Brazil lacks registries on the prevalence of primary total hip arthroplasty (THA) fixation methods. Objective: (i) to describe the demographic profile of patients who underwent THA in the public health system of the municipality of São Paulo during the last 12 years and (ii) to compare fixation methods regarding costs, hospital stay length, and death rates. Methods: This is an ecological study conducted with data available on TabNet, a platform belonging to DATASUS. Public data (from the government health system) on THA procedures performed in São Paulo from 2008 to 2019 were extracted. Gender, age, city region, THA fixation method, number of surgeries, costs, hospital stay length, and death rates were analyzed. Results: We analyzed 7,673 THA, of which 6220 (81%) were performed via cementless/hybrid fixation and 1453 (19%), via the cemented technique. Cementless/hybrid fixation had a higher cost (US$ 495.27) than the cemented one (p < 0.001). Nevertheless, hospital stay length was 0.87 days longer for cemented fixation than the cementless/hybrid one. We found no significant difference in death rates between THA fixation methods. Conclusion: THA cementless/hybrid fixation is prevalent in the municipality of São Paulo, which had higher total costs and shorter hospitalizations than cemented fixation. We found no difference between THA fixation methods and death rates. Level of Evidence IV, Case Series.

RESUMO No Brasil, não há registros da prevalência do tipo de fixação da artroplastia total de quadril (ATQ). Objetivo: (i) Descrever perfil demográfico de pacientes submetidos à ATQ no Sistema Único de Saúde de São Paulo durante os últimos doze anos; e (ii) comparar as técnicas de fixação de ATQ quanto aos custos, tempo de internação (TI) e taxa de óbito. Métodos: Estudo ecológico, com dados disponíveis na TabNet do DATASUS. Dados públicos de procedimentos de ATQ eletivos realizados em São Paulo de 2008 a 2019 foram extraídos. Foram analisados: sexo, idade, região municipal, método de fixação em ATQ, número de cirurgias, custo, tempo de internação e óbitos. Resultados: Foram analisadas 7.673 ATQs, sendo 6.220 (81%) não-cimentada/híbridas e 1.453 (19%) cimentadas. A fixação não-cimentada/híbrida teve custo maior em US$ 495,27 do que a cimentada (p < 0,001). Entretanto, TI foi 0,87 dia mais longo na fixação cimentada. Não houve diferença significativa nas taxas de óbito entre os métodos de fixação. Conclusão: A fixação não-cimentada/híbrida na ATQ é prevalente em São Paulo, e apresentou maior custo total, porém menor tempo de internação do que a fixação cimentada. Não houve diferença entre o método de fixação em ATQ e a taxa de óbito. Nível de Evidência IV, Série de Casos.