Prospective Study of the Assessment of Anxiety Symptoms after Minimally Invasive Lumbar Decompression.

Objective To analyze associations between anxiety and postsurgical clinical outcomes in patients who underwent minimally invasive lumbar decompression surgery in addition to comparing symptoms of anxiety and depression before and after surgery. Methods This prospective cohort study of patients who underwent minimally invasive lumbar decompression surgery. Clinical outcomes were measured before and 6 months after surgery using the Visual Analog Scale (VAS), Global Perceived Effect of Change (GPE), Hospital Anxiety and Depression Scale (HADS), and Oswestry Disability Index (ODI). Based on the presurgical anxiety score, patients were categorized into anxious and non-anxious patients, and the outcomes were compared. Results The patients of both groups obtained similar results concerning the clinical outcomes evaluated. Preoperative HADS scores decreased significantly 6 months after surgery in both anxiety (8.70 ± 3.48 vs. 5.75 ± 3.91) and depression (6.95 ± 3.54 vs. 5.50 ± 2.99). The VAS scale for the back (-2.8 ± 3.64) and legs (-5.5 ± 3.5) showed a reduction in pain. Conclusion Minimally invasive lumbar decompression surgery promoted clinical and functional improvement, not being affected by preoperative anxiety symptoms. Mental health indicators showed a significant reduction in symptoms 6 months after surgery.

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.

Comparative Effects of Intra-Articular versus Intravenous Mesenchymal Stromal Cells Therapy in a Rat Model of Osteoarthritis by Destabilization of Medial Meniscus.

Transplanted mesenchymal stromal cells (MSCs) exhibit a robust anti-inflammatory and homing capacity in response to high inflammatory signals, as observed in studies focused on rheumatic diseases that target articular cartilage (AC) health. However, AC degradation in osteoarthritis (OA) does not necessarily coincide with a highly inflammatory joint profile. Often, by the time patients seek medical attention, they already have damaged AC. In this study, we examined the therapeutic potential of a single bone marrow MSC transplant (2 × 106 cells/kgbw) through two different routes: intra-articular (MSCs-IAt) and intravenous (MSCs-IVt) in a preclinical model of low-grade inflammatory OA with an established AC degeneration. OA was induced through the destabilization of the medial meniscus (DMM) in female Wistar Kyoto rats. The animals received MSCs 9 weeks after surgery and were euthanized 4 and 12 weeks post-transplant. In vivo and ex vivo tracking of MSCs were analyzed via bioluminescence and imaging flow cytometry, respectively. Cytokine/chemokine modulation in serum and synovial fluid was measured using a multiplex panel. AC degeneration was quantified through histology, and hindlimb muscle balance was assessed with precision weighing. To our knowledge, we are the first group to show the in vivo (8 h) and ex vivo (12 h) homing of cells to the DMM-OA joint following MSCs-IVt. In the case of MSCs-IAt, the detection of cellular bioluminescence at the knee joint persisted for up to 1 week. Intriguingly, intra-articular saline injection (placebo-IAt) resulted in a worse prognosis of OA when compared to a non-invasive control (placebo-IVt) without joint injection. The systemic cytokines/chemokines profile exhibited a time-dependent variation between transplant routes, displaying a transient anti-inflammatory systemic response for both MSCs-IVt and MSCs-IAt. A single injection of MSCs, whether administered via the intra-articular or intravenous route, performed 9 weeks after DMM surgery, did not effectively inhibit AC degeneration when compared to a non-invasive control.

Eight weeks of a lower limb resistance training protocol and gait performance in patients with symptomatic mild to moderate knee osteoarthritis.

BACKGROUND: The role of strengthening the lower limbs to optimize the biomechanics of the hip, knee and ankle during walking in patients with knee osteoarthritis, is still unclear. This study aimed to analyse the walking biomechanics of individuals with symptomatic mild to moderate knee osteoarthritis before and after a simplified lower limb resistance training protocol, focused on knee joint exercises with individualized load. METHODS: Forty-one patients with symptomatic and radiographic mild to moderate knee osteoarthritis underwent 3D gait analysis pre-post 8 weeks lower limb resistance training protocol performed 3 times a week. Parameters investigated were spatiotemporal, sagittal range of motion, flexion and extension minimum and maximum values, power and moment of hip, knee and ankle, as well as self-reported pain and physical function by the Western Ontario MacMaster University Osteoarthritis Index. Paired t test, Wilcoxon, Spearman's correlation and a logistic model were used for statistical analysis, with p < 0.05. Pain improvement more than 2 points was considered clinically relevant. The effect size (ES) was calculated using Cohen's d. RESULTS: Post protocol walking speed increased 6.7% (ES: 0.711), cadence 3.7% (ES: 0.655), stride length 2.6% (ES: 0.542), and double support time reduced 6.9% (ES:0.459). It was also observed a significant increase in one maximum repetition test for legpress 46%, knee extension 23% and knee flexion chair 27% (p < 0.001). Patients reported a 62.5% reduction in pain (ES:1.518) and 64.9% improvement in physical function (ES:1.376). 82% of the patients presented more than 2 points improvement in pain. No evidence of strong correlations between pain, strength gains and gait parameters were found. CONCLUSIONS: There was a significant and clinical improvement of spatiotemporal gait parameters, pain, physical function, and strength after 8-week lower limb resistance training protocol. Patients who had a clinically relevant pain improvement presented better gait performance.

The American College of Surgeons National Surgical Quality Improvement Program surgical risk calculator is not reliable in predicting complications and length of stay after primary total hip arthroplasty at an institution implementing clinical pathways.

INTRODUCTION: The authors aimed to: (1) determine how length of stay (LOS) and complication rates changed over the past 10 years, in comparison to values estimated by the ACS-NSQIP surgical risk calculator, at a single private institution open to external surgeons; and (2) determine preoperative patient factors associated with complications. METHODS: We retrospectively assessed 1018 consecutive patients who underwent primary elective THA over 10 years. We excluded 87 with tumours and 52 with incomplete records. Clinical data of the remaining 879 were used to determine real LOS and rate of 9 adverse events over time, as well as to estimate these values using the risk calculator. Its predictive reliability was represented on receiver operating characteristic curves. Multivariable analyses were performed to determine associations of complications with age, sex, ASA score, diabetes, hypertension, heart disease, smoking and BMI. RESULTS: Over the 10-year period, real LOS and real complication rates decreased considerably, while LOS and complication rates estimated by the surgical risk calculator had little or no change. The difference between real and estimated LOS decreased over time. The overall estimated and real rates of any complication were respectively 3.3% and 2.8%. The risk calculator had fair reliability for predicting any complications (AUC 0.72). Overall estimated LOS was shorter than the real LOS in 764 (86.9%) patients. Multivariable analysis revealed risks of any complication to be greater in patients aged ⩾75 (OR = 4.36, p = 0.002), and with hypertension (OR = 3.13, p = 0.016). CONCLUSIONS: Since the implementation of clinical pathways at our institution, real LOS and complication rates decreased considerably, while LOS and complication rates estimated by the surgical risk calculator had little or no change. The difference between real and estimated LOS decreased over time, which could lead some clinicians to reconsider their discharge criteria, knowing that advanced age and hypertension increased risks of encountering complications.

Comparative effects of intra-articular versus intravenous mesenchymal stromal cells therapy in a rat model of osteoarthritis by destabilization of medial meniscus

Transplanted mesenchymal stromal cells (MSCs) exhibit a robust anti-inflammatory and homing capacity in response to high inflammatory signals, as observed in studies focused on rheumatic diseases that target articular cartilage (AC) health. However, AC degradation in osteoarthritis (OA) does not necessarily coincide with a highly inflammatory joint profile. Often, by the time patients seek medical attention, they already have damaged AC. In this study, we examined the therapeutic potential of a single bone marrow MSC transplant (2 × 106 cells/kgbw) through two different routes: intra-articular (MSCs-IAt) and intravenous (MSCs-IVt) in a preclinical model of low-grade inflammatory OA with an established AC degeneration. OA was induced through the destabilization of the medial meniscus (DMM) in female Wistar Kyoto rats. The animals received MSCs 9 weeks after surgery and were euthanized 4 and 12 weeks post-transplant. In vivo and ex vivo tracking of MSCs were analyzed via bioluminescence and imaging flow cytometry, respectively. Cytokine/chemokine modulation in serum and synovial fluid was measured using a multiplex panel. AC degeneration was quantified through histology, and hindlimb muscle balance was assessed with precision weighing. To our knowledge, we are the first group to show the in vivo (8 h) and ex vivo (12 h) homing of cells to the DMM–OA joint following MSCs-IVt. In the case of MSCs-IAt, the detection of cellular bioluminescence at the knee joint persisted for up to 1 week. Intriguingly, intra-articular saline injection (placebo-IAt) resulted in a worse prognosis of OA when compared to a non-invasive control (placebo-IVt) without joint injection. The systemic cytokines/chemokines profile exhibited a time-dependent variation between transplant routes, displaying a transient anti-inflammatory systemic response for both MSCs-IVt and MSCs-IAt. A single injection of MSCs, whether administered via the intra-articular or intravenous route, performed 9 weeks after DMM surgery, did not effectively inhibit AC degeneration when compared to a non-invasive control.

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.

Impact of Hyaluronic Acid on the Viability of Mesenchymal Cells Derived from Adipose Tissue Grown in Collagen Type I/III Membrane.

Objective To evaluate in vitro the viability of mesenchymal stem cells derived from adipose tissue (AD-MSCs) in different commercial solutions of hyaluronic acid (HA) before and after being sowed in collagen I/III membrane. Methods In the first stage, the interaction between AD-MSCs was analyzed with seven different commercial products of HA, phosphate buffered saline (PBS), and bovine fetal serum (BFS), performed by counting living and dead cells after 24, 48 and 72 hours. Five products with a higher number of living cells were selected and the interaction between HA with AD-MSCs and type I/III collagen membrane was evaluated by counting living and dead cells in the same time interval (24, 48 and 72 hours). Results In both situations analyzed (HA + AD-MSCs and HA + AD-MSCs + membrane), BFS presented the highest percentage of living cells after 24, 48 and 72 hours, a result higher than that of HA. Conclusion The association of HA with AD-MSCs, with or without membrane, showed no superiority in cell viability when compared with BFS.

Impact of Hyaluronic Acid on the Viability of Mesenchymal Cells Derived from Adipose Tissue Grown in Collagen Type I/III Membrane / Impacto do ácido hialurônico na viabilidade das células mesenquimais derivadas do tecido adiposo cultivadas em membrana de colágeno tipo I/III

Abstract Objective To evaluate in vitro the viability of mesenchymal stem cells derived from adipose tissue (AD-MSCs) in different commercial solutions of hyaluronic acid (HA) before and after being sowed in collagen I/III membrane. Methods In the first stage, the interaction between AD-MSCs was analyzed with seven different commercial products of HA, phosphate buffered saline (PBS), and bovine fetal serum (BFS), performed by counting living and dead cells after 24, 48 and 72 hours. Five products with a higher number of living cells were selected and the interaction between HA with AD-MSCs and type I/III collagen membrane was evaluated by counting living and dead cells in the same time interval (24, 48 and 72 hours). Results In both situations analyzed (HA + AD-MSCs and HA + AD-MSCs + membrane), BFS presented the highest percentage of living cells after 24, 48 and 72 hours, a result higher than that of HA. Conclusion The association of HA with AD-MSCs, with or without membrane, showed no superiority in cell viability when compared with BFS.

Resumo Objetivo Avaliar in vitro a viabilidade das células-tronco mesenquimais derivadas do tecido adiposo (AD-CTMs) em diferentes soluções comerciais de ácido hialurônico (AH) antes e após serem semeadas em membrana de colágeno I/III. Métodos Na primeira etapa, analisou-se a interação entre AD-CTMs com sete diferentes produtos comerciais de AH, salina tamponada com fosfato (PBS, na sigla em inglês) e soro fetal bovino (SFB), realizada pela contagem das células vivas e mortas após 24, 48 e 72 horas. Foram selecionados cinco produtos com maior número de células vivas e avaliou-se a interação entre o AH com AD-CTMs e a membrana de colágeno tipo I/III pela contagem de células vivas e mortas no mesmo intervalo de tempo (24, 48 e 72 horas). Resultados Em ambas as situações analisadas (AH + AD-CTM e AH + AD-CTM + membrana), o SFB apresentou a maior porcentagem de células vivas após 24, 48 e 72 horas, resultado superior ao do AH. Conclusão A associação do AH com as AD-CTMs, com ou sem a membrana, não demonstrou superioridade na viabilidade celular quando comparado com SFB.

Report of a clinical and laboratory management of cell therapy for knee cartilage in the face of mycoplasma contamination.

To describe a case of autologous chondrocyte implantation after cell culture contamination by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy in a patient with focal chondral lesion. A 45-year-old male patient, complaining of chronic pain on the knee and no history of trauma. He had a chondral lesion in the trochlear region of the femur and clinical tests compatible with pain in the anterior compartment of the knee. Conservative treatment failed to alleviate symptoms. Surgical treatment was indicated, but due to the size of the lesion, membrane-assisted autologous chondrocyte implantation was the technique of choice. Cartilage biopsies were collected from the intercondylar region of the distal femur. After isolation, chondrocytes were expanded ex vivo in a trained laboratory, for three weeks, and seeded onto a commercially available collagen membrane prior to implantation in the knee. Two days before surgery, a cell culture sample tested positive for Mycoplasma pneumoniae. The source of contamination was found to be autologous blood serum, extracted from the patient´s peripheral vein, and used to supplement the cell culture medium. After treating the patient with antibiotics, all procedures were repeated and the new final cell product, free from contaminants, was successfully implanted. We discuss the strategies available to deal with this situation, and describe the results of this particular case, which led to modifications in the autologous chondrocyte implant protocol.

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.

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.

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.

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

ABSTRACT 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.

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

ABSTRACT 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

Report of a clinical and laboratory management of cell therapy for knee cartilage in the face of mycoplasma contamination

ABSTRACT To describe a case of autologous chondrocyte implantation after cell culture contamination by Mycoplasma pneumoniae and the measures taken to successfully complete cell therapy in a patient with focal chondral lesion. A 45-year-old male patient, complaining of chronic pain on the knee and no history of trauma. He had a chondral lesion in the trochlear region of the femur and clinical tests compatible with pain in the anterior compartment of the knee. Conservative treatment failed to alleviate symptoms. Surgical treatment was indicated, but due to the size of the lesion, membrane-assisted autologous chondrocyte implantation was the technique of choice. Cartilage biopsies were collected from the intercondylar region of the distal femur. After isolation, chondrocytes were expanded ex vivo in a trained laboratory, for three weeks, and seeded onto a commercially available collagen membrane prior to implantation in the knee. Two days before surgery, a cell culture sample tested positive for Mycoplasma pneumoniae. The source of contamination was found to be autologous blood serum, extracted from the patient´s peripheral vein, and used to supplement the cell culture medium. After treating the patient with antibiotics, all procedures were repeated and the new final cell product, free from contaminants, was successfully implanted. We discuss the strategies available to deal with this situation, and describe the results of this particular case, which led to modifications in the autologous chondrocyte implant protocol.

Lumbar arthrodesis in degenerative spine: post operative results and radiographic evaluation / Artrodese lombar nas afecções degenerativas da coluna: análise radiográfica e resultados pós-operatórios / Lumbar arthrodesis in degenerative spine: post operative results and radiographic evaluation

ABSTRACT Objective: To relate the radiographic fusion rate and the surgical results in patients undergoing posterolateral arthrodesis with instrumentation of the lumbar spine for the treatment of degenerative disorders. Method: A descriptive, retrospective, case series, observational study, based on medical records and imaging studies of 76 patients over 18 years of age (39 to 88 years) who underwent posterolateral lumbar arthrodesis. Data related to the presence of comorbidities were compiled and clinical outcomes were measured using specific questionnaires collected pre-surgical and 1 year after surgery. Fusion quality, as described by Christensen, was assessed from radiographic images by two examiners. The VAS, EQ-5D and Roland Morris questionnaires were used preoperatively and 1 year after surgery to assess pain, quality of life and function, respectively. Result: It was observed improvement in pain, function and quality of life after 1 year post-surgical. Pain, measured by VAS, had a reduction from 7.92 to 3.16 (p-value <0.001), the function evaluated by the Roland Morris score, also showed a reduction from 14.90 to 7.06 (p-value <0.001) . Culminating with the improvement in quality of life, measured by the EQ-5D, where there was a median increase in the score from 0.5672 to 0.7002 (p-value = 0.002). Conclusion: The absence of radiographic fusion has no direct correlation with worse results in clinical outcomes at 01 year after surgery. Most patients showed clinical improvement with no statistical difference in relation to cases in which bone fusion was obtained. Level of evidence IV; retrospective observation.

RESUMO: Objetivo: Relacionar a taxa de fusão radiográfica e os resultados cirúrgicos nos pacientes submetidos a artrodese posterolateral com instrumentação da coluna lombar para tratamento de afecções degenerativas. Método: Estudo observacional retrospectivo descritivo, tipo série de casos, com base em prontuários médicos e exames de imagem de 76 pacientes maiores de 18 anos (39 a 88 anos), submetidos a artrodese lombar posterolateral. Dados relacionados a presença de comorbidades foram compilados e os desfechos clínicos mensurados por meio de questionários específicos coletados no pré-cirúrgico e após um ano pós-cirúrgico. A qualidade da fusão, conforme descrita por Christensen, foi avaliada a partir de imagens radiográficas por dois examinadores. Os questionários de EVA, EQ-5D e Roland Morris foram utilizados no pré-cirúrgico e um ano pós-cirúrgico para avaliar dor, qualidade de vida e função, respectivamente. Resultado: Observou se melhora na dor, função e qualidade de vida após um ano pós-cirúrgico. A dor, mensurada pelo EVA teve uma redução de 7,92 para 3,16 (p-valor <0,001), a função avaliada pelo escore Roland Morris, também apresentou redução de 14,90 para 7,06 (p-valor <0,001). Culminando com a melhora na qualidade de vida, mensurada pelo EQ-5D, onde observou-se um aumento mediano escore de 0,5672 para 0,7002 (p-valor = 0,002). Conclusão: A ausência de fusão radiográfica não tem correlação direta com piores resultados nos desfechos clínicos em um ano de pós-cirúrgico. Maioritariamente, os pacientes apresentaram melhora clínica sem diferença estatística em relação aos casos em que foi obtido fusão óssea. Nível de evidência IV; Observacional retrospectivo.

RESUMEN: Objetivo: Relacionar ei índice de fusión radiográfica y los resultados quirúrgicos en pacientes sometidos a artrodesis posterolateral con instrumentación de columna lumbar para el tratamiento de trastornos degenerativos. Método: Estudio descriptivo, retrospectivo, serie de casos, observacional, basado en historias clínicas y estudios de imagen de 76 pacientes may ores de 18 anos (39 a 88 anos) a quienes se les realizó artrodesis lumbar posterolateral. Se recopilaron datos relacionados con la presencia de comorbilidades y se midieron los resultados clínicos mediante cuestionarios específicos recogidos antes de la cirugía y al año de la cirugía. La calidad de la fusión, según lo descrito por Christensen, fue evaluada a partir de imágenes radiográficas por dos examinadores. Los cuestionarios VAS, EQ-5D y Roland Morris se utilizaron en el preoperatorio y 1 año después de la cirugía para evaluar el dolor, la calidad de vida y la función, respectivamente. Resultado: Se observó mejoría en el dolor, función y calidad de vida después de 1 año posquirúrgico. El dolor, medido por EVA, tuvo una reducción de 7,92 a 3,16 (p-valor <0,001), la función evaluada por el puntaje de Roland Morris, también mostró una reducción de 14,90 a 7,06 (p-valor <0,001). Culminando con la mejora en la calidad de vida, medida por el EQ-5D, donde hubo un aumento mediano en el puntaje de 0,5672 a 0,7002 (p-valor = 0,002). Conclusión: La ausencia de fusión radiográfica no tiene correlación directa con peores resultados en los resultados clínicos al 01 año de la cirugía. La mayoría de los pacientes presentaron mejoría clínica sin diferencia estadística en relación a los casos en los que se obtuvo fusión ósea. Nivel de evidencia IV; observación retrospectiva.

Lumbar Decompression Versus Spinal Fusion in a Private Outpatient Setting: A Retrospective Study with Three Years of Follow-up.

Objective To compare pain, function, quality of life and adverse events of lumbar decompression and spinal fusion in patients with degenerative spinal pathologies who participated in a second opinion program for spinal surgeries with a 36-month follow-up. Methods The data for this retrospective cohort were withdrawn from a private healthcare system between June 2011 and January 2014. The study sample consisted of 71 patients with a lumbar spine surgical referral. The outcomes for the comparisons between lumbar decompression and spinal fusion were quality of life (evaluated through the EuroQoL 5D), pain (measured by the Numerical Rating Scale) and function (assessed through the Roland Morris Disability Questionnaire) measured at baseline, and at 12 and 36 months after the surgical procedures. The definitions of recovery were established by the minimal clinically important difference (MCID). The baseline differences between the groups were analyzed by non-paired t -test, and the differences in instrument scores between time points, by generalized mixed models. The results were presented as mean values adjusted by the models and 95% confidence intervals. Results Concerning the surgical techniques, 22 patients were submitted to spinal fusion and 49 patients, to lumbar decompression. As for the comparisons of the findings before and after the surgical interventions, the MCID was achieved in all outcomes regarding quality of life, pain and function at both time points when compared to baseline scores Moreover, concerning the complication rates, only lumbar decompression presented a surgical rate of 4% ( n = 3) for recurrence of lumbar disc hernia. Conclusion Patients with degenerative spinal pathologies present improvements in long-term outcomes of pain, function and quality of life which are clinically significant, no matter the surgical intervention.