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.

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.

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.

Validation and Implementation of 4-domain Patient-reported Outcome Measures (PROMs) Tailored for Orthopedic Sports Medicine.

The validation of a 4-domain PROM tailored to orthopedic sports medicine was performed through item generation, item scaling, validity and reliability testing, statistical analysis, as well as item reduction. Conbrach's alpha was used to verify item homogeneity, i. e. their accuracy or consistency. This PROM showed acceptable statistical accuracy and clinical applicability for a variety of surgical treatments, regardless of the anatomical injury sites. Moreover, this PROM considers the athletes' primary physical demands in an non-injured baseline condition, their motivation to continue sports practice and participation, and the influence of sports practice on their quality of life. This 4-domain PROM tailored for orthopedic sports medicine appears to be a valid tool to assess athletes and high-performing practitioners with sports injuries, recording their perception of injury, expectations of treatment; evaluation of postoperative care and treatment received, and perceived outcomes compared to their pre-injury status of physical demands in sports activity. The tool is unique, allowing direct comparisons between athletes' perception of pre-injury baseline, injury, treatment, and outcome. It will be a welcome adjunct to the sports medicine professional's tool box when assessing athlete's status and outcome after injury and intervention.

Hydrogel implant is as effective as osteochondral autologous transplantation for treating focal cartilage knee injury in 24 months.

PURPOSE: The treatment approach for a patient with knee joint focal cartilage lesion is a difficult decision. To date, there has been no randomized clinical trial involving Hydrogel (Cartiva™). This study evaluated and compared the results of a hydrogel implant (Cartiva™) with autologous osteochondral transplantation (AOT) for treating knee joint focal cartilage lesions. METHODS: Thirty-eight symptomatic patients, with a focal cartilage lesion of Outerbridge grades III or IV, were randomized into one of two groups according to the inclusion and exclusion criteria. Group I underwent AOT, and Group II was treated with a Hydrogel implant. Patients were evaluated preoperatively and again postoperatively at 6, 12, and 24 months using the subjective International Knee Documentation Committee (IKDC) scores, Visual Analog Scale for Pain (VAS Pain), Activities of Daily Living Scale (ADLS) and Lysholm score. RESULTS: Both groups showed significant improvements from baseline (pre-surgery) to post-surgery (6, 12, and 24 months; p < 0.05), but there was no difference between the groups. Regarding complications, prolonged pain was observed in four patients (10.5%), two from each group, with a regression of symptoms within 1 year. CONCLUSION: The Hydrogel implant showed similar efficiency as the autologous osteochondral graft for treating knee joint focal cartilage lesions. Both techniques showed satisfactory results compared to preoperative status. The Hydrogel implant was safe and effective, and it provided good stability and joint function at 2-year follow-up. LEVEL OF EVIDENCE: I.

Second opinion for degenerative spinal conditions: an option or a necessity? A prospective observational study.

BACKGROUND: Second opinions may improve quality of patient care. The primary objective of this study was to determine the concordance between first and second diagnoses and opinions regarding need for spinal surgery among patients with back or neck pain that have been recommended spinal surgery. METHODS: We performed a prospective observational study of patients who had been recommended for spinal surgery and received a second opinion between May 2011 and May 2012 at the Hospital Israelita Albert Einstein on the advice of their health insurance company. A physiatrist and orthopaedic surgeon independently performed the second assessment. If both agreed surgery was indicated, or consensus could not be reached, participants attended a spine review panel for a final recommendation. Descriptive analyses compared diagnoses and management plans of the first and second opinions. RESULTS: Of 544 referred patients, 16 (2.9%) did not meet inclusion criteria, 43 (7.9%) refused participation and 485 were included. Diagnoses differed from the first opinion for 290 (59.8%). Diagnoses of cervical and lumbar radiculopathy were concordant in 36/99 (36.4%) and 116/234 (49.6%) respectively. The second opinion was for conservative treatment for 168 (34.6%) participants, 27 (5.6%) were not considered to have a spine condition, and 290 (59.8%) were referred to the review board. 60 participants did not attend the board review and therefore did not receive a final recommendation. Board review was conservative treatment for an additional 67 participants, 20 were not considered to have a spine condition and 143 participants were recommended surgery. Overall, 33.6% received a final opinion of surgery (143/425) although only 66 (15.5%) received the same surgical recommendation, 235 (55.3%) were advised to have conservative treatment, and 47 (11.1%) were not considered to have a spinal diagnosis. CONCLUSIONS: We found a large discordance between first and second opinions regarding diagnosis and need for spinal surgery. This suggests that obtaining a second opinion could reduce potentially unnecessary surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN07143259 . Registered 21 November 2011.

Effect of Human Adipose Tissue Mesenchymal Stem Cells on the Regeneration of Ovine Articular Cartilage.

Cell therapy is a promising approach to improve cartilage healing. Adipose tissue is an abundant and readily accessible cell source. Previous studies have demonstrated good cartilage repair results with adipose tissue mesenchymal stem cells in small animal experiments. This study aimed to examine these cells in a large animal model. Thirty knees of adult sheep were randomly allocated to three treatment groups: CELLS (scaffold seeded with human adipose tissue mesenchymal stem cells), SCAFFOLD (scaffold without cells), or EMPTY (untreated lesions). A partial thickness defect was created in the medial femoral condyle. After six months, the knees were examined according to an adaptation of the International Cartilage Repair Society (ICRS 1) score, in addition to a new Partial Thickness Model scale and the ICRS macroscopic score. All of the animals completed the follow-up period. The CELLS group presented with the highest ICRS 1 score (8.3 ± 3.1), followed by the SCAFFOLD group (5.6 ± 2.2) and the EMPTY group (5.2 ± 2.4) (p = 0.033). Other scores were not significantly different. These results suggest that human adipose tissue mesenchymal stem cells promoted satisfactory cartilage repair in the ovine model.

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.

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.

Monitoring health as an opportunity to categorize preventative and early-treatment actions in a self-care journey: our experience with a Healthcare Magenta Scorecard.

Background: Applying a digital health intervention to measure health and wellbeing status offers opportunities to guide and augment healthcare and promotion. In our scenario, we consider mainly digital-native patients and present an evaluation of a new Healthcare Magenta Scorecard towards this end. Methods: Grounded in the six domains of health and promotion (physical activity; sleep quality; nutrition; habits/lifestyle; mental health; quality of life) we developed a health Magenta Scorecard (Magenta Score), a mobile based Electronic Patient Reported Outcomes (e-PRO) that measures patients health and wellbeing every 3-5 months. The Magenta Scorecard was derived from previously published evidence-based instruments. We collected data as patients were onboarded into our healthcare system (T0 and T1, time span between measurements, 141 days) and provided correlations among our domains of care. Results: A total of 1,622 participants responded to T0 and T1 our Magenta Scorecard. Participants mean age was 31.3 [95% confidence interval (CI): 31.2-31.5] years and female (63.4%). Fifty-five percent (n=892) of our sample were categorized as relating to Health and Wellbeing promotion, 8.5% (n=138) disease management, 35.7% (n=579) self-care care support and only 0.8% (n=13) pertained to case management. From our care coordination guided approach, our Magenta Scorecards reported mean improvement across the study cohort of 26 ± standard deviation (SD) points, from T0 (649, 95% CI: 643-656) to T1 (675, 95% CI: 668-682). Our Magenta Scorecard domains had significant, albeit weak spearman correlations. Conclusions: We demonstrated our Magenta Scorecard rationale and its guided approach. The Magenta Scorecard displayed adequate responsiveness and was significantly correlated across all of the domains investigated. Further prospective research is needed to validate our results in the long term.

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.

Bony and soft tissue landmarks of the ACL tibial insertion site: an anatomical study.

PURPOSE: To identify and describe reliable landmarks for tibial tunnel placement in anatomical ACL reconstruction. METHODS: Eight non-paired cadaveric knees were used. After dissection, the tibial plateaus, menisci and ACL insertions were grossly observed to identify anatomical landmarks and relate them to the ACL insertion site. The specimens were scanned with a laser scanner, and 3-Dimensional images were obtained. Measurements of the ACL tibial insertion were taken. The center of the ACL and its bundles was measured regarding the distance from the medial tibial eminence and intermeniscal ligament. RESULTS: The medial tibial eminence demonstrated a constant relationship with the ACL tibial insertion site center and its bundles, as well as the intermeniscal ligament. The anterior root of the lateral meniscus had a variable relationship with the ACL tibial insertion. The length of the ACL tibial insertion was 18.1 ± 2.8 mm and the width was 10.7 ± 1.9 mm. The width of the AM bundle was 11.1 ± 2.1 mm and the PL 7.9 ± 2.0 mm. The ACL center was 9.1 ± 1.5 mm posterior to the intermeniscal ligament and 5.7 ± 1.1 mm anterior to a projected line from the apex of the medial tibial eminence. The center of the AM bundle was at 4.6 ± 0.7 mm posterior to the intermeniscal ligament. The center of the PL bundle was 1.4 ± 0.7 mm anterior to the medial tibial eminence. CONCLUSION: The medial tibial eminence and the intermeniscal ligament may be used as landmarks to guide the correct tunnel placement in an anatomical ACL reconstruction.

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.

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.

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.

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.

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.

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.