Results and complications of bilateral limb lengthening in achondroplasia: a retrospective analysis.

Background: Achondroplasia is one of the main causes of disharmonic dwarfism. Patients with achondroplasia might have physical and psychological limitations due to their disproportionate stature. Surgical limb lengthening is the only practical option available to achieve a stature comparable to normal population range. The purpose of this study is to analyze results and complications of our lengthening protocol. Methods: A retrospective analysis was performed on 33 patients with achondroplasia (21 females and 12 males) undergoing simultaneous bilateral tibia or femur lengthening in four surgical stages from 2017 to 2021 (46 lengthening procedures, with a total of 56 tibias and 36 femurs). For each patient, patients' characteristics and antero-posterior and lateral radiographs were obtained. The following parameters were analyzed: duration of lengthening with external fixator, amount of lengthening, complications or events that influenced outcomes and the healing index (HI). Results: The average tibial and femoral gain was 7.9 cm and 6.9 cm, respectively. The tibiae achieved better results than the femurs (p = 0.005). Nineteen complications were reported for 92 segments (20.7%), and the variables influencing complications were: step (p = 0.002) and fixation duration (p = 0.061). Conclusions: Bilateral parallel lower limb lengthening in four surgical steps may be a viable technique in patients with achondroplasia.

Proximal hip fractures in 71,920 elderly patients: incidence, epidemiology, mortality and costs from a retrospective observational study.

BACKGROUND: The risk of proximal femoral fractures increases with aging, causing significant morbidity, disability, mortality and socioeconomic pressure. The aims of the present work are (1) to investigate the epidemiology and incidence of these fractures among the elderly in the Region of Lombardy; (2) to identify the factors influencing survival; (3) to identify the factors influencing hospitalization and post-operative costs. METHODS: The Region of Lombardy provided anonymized datasets on hospitalized patients with a femoral neck fracture between 2011 and 2016, and anonymized datasets on extra-hospital treatments to track the patient history between 2008 and 2019. Statistical evaluations included descriptive statistics, survival analysis, Cox regression and multiple linear models. RESULTS: 71,920 older adults suffered a femoral fracture in Lombardy between 2011 and 2016. 76.3% of patients were females and the median age was 84. The raw incidence of fractures was stable from year 2011 to year 2016, while the age-adjusted incidence diminished. Pertrochanteric fractures were more spread than transcervical fractures. In patients treated with surgery, receiving treatment within 48 h reduced the hazard of death within the next 24 months. Combined surgical procedures led to increased hazard in comparison with arthroplasty alone, while no differences were observed between different arthroplasties and reduction or fixation. In patients treated conservatively, age and male gender were associated with higher hazard of death. All patients considered, the type of surgery was the main factor determining primary hospitalization costs. A higher number of surgeries performed by the index hospital in the previous year was associated with financial savings. The early intervention significantly correlated with minor costs. CONCLUSIONS: The number of proximal femoral fractures is increasing even if the age-adjusted incidence is decreasing. This is possibly due to prevention policies focused on the oldest cohort of the population. Two policies proved to be significantly beneficial in clinical and financial terms: the centralization of patients in high-volume hospitals and a time limit of 48 h from fracture to surgery. TRIAL REGISTRATION: Non applicable.

Efficacy of biomaterials for lateral bone augmentation performed with guided bone regeneration. A network meta-analysis.

Bone regeneration is often required concomitant with implant placement to treat a bone fenestration, a dehiscence, and for contouring. This systematic review assessed the impact of different biomaterials employed for guided bone regeneration (GBR) simultaneous to implant placement on the stability of radiographic peri-implant bone levels at ≥12 months of follow-up (focused question 1), as well as on bone defect dimension (width/height) changes at re-assessment after ≥4 months (focused question 2). Only randomized controlled trials (RCTs) and controlled clinical trials (CCTs) that compared different biomaterials for GBR were considered. A Bayesian network meta-analysis (NMA) was performed using a random-effects model. A ranking probability between treatments was obtained, as well as an estimation of the surface under the cumulative ranking value (SUCRA). Overall, whenever the biological principle of GBR was followed, regeneration occurred in a predictable way, irrespective of the type of biomaterial used. A lower efficacy of GBR treatments was suggested for initially large defects, despite the trend did not reach statistical significance. Regardless of the biomaterial employed, a certain resorption of the augmented bone was observed overtime. While GBR was shown to be a safe and predictable treatment, several complications (including exposure, infection, and soft tissue dehiscence) were reported, which tend to be higher when using cross-linked collagen membranes.

How do patients sleep after orthopaedic surgery? Changes in objective sleep parameters and pain in hospitalized patients undergoing hip and knee arthroplasty.

PURPOSE: The aim of this observational cohort study was to assess actigraphy-based sleep characteristics and pain scores in patients undergoing knee or hip joint replacement and hospitalized for ten days after surgery. METHODS: N=20 subjects (mean age: 64.0±10.39 years old) wore the Actiwatch 2 actigraph (Philips Respironics, USA) to record sleep parameters for 11 consecutive days. Subjective scores of pain, by a visual analog scale (VAS), were constantly monitored and the following evaluation time points were considered for the analysis: pre-surgery (PRE), the first (POST1), the fourth (POST4), and the tenth day (POST10) after surgery. RESULTS: Sleep quantity and timing parameters did not differ from PRE to POST10, during the hospitalization whereas sleep efficiency and immobility time significantly decreased at POST1 compared to PRE by 10.8% (p=0.003; ES: 0.9, moderate) and 9.4% (p=0.005; ES: 0.86, moderate) respectively, and sleep latency increased by 18.7 min (+320%) at POST1 compared to PRE (p=0.046; ES: 0.70, moderate). Overall, all sleep quality parameters showed a trend of constant improvement from POST1 to POST10. VAS scores were higher in the first day post-surgery (4.58 ± 2.46; p=0.0011 and ES: 1.40, large) compared to POST10 (1.68 ± 1.58). During the time, mean VAS showed significant negative correlations with mean sleep efficiency (r = -0.71; p=0.021). CONCLUSION: Sleep quantity and timing parameters were stable during the entire hospitalization whereas sleep quality parameters significantly worsened the first night after surgery compared to the pre-surgery night. High scores of pain were associated with lower overall sleep quality.

A longitudinal analysis of humoral, T cellular response and influencing factors in a cohort of healthcare workers: Implications for personalized SARS-CoV-2 vaccination strategies.

Introduction: SARS-CoV-2 mRNA vaccinations elicit both virus-specific humoral and T-cell responses, but a complex interplay of different influencing factors, such as natural immunity, gender, and age, guarantees host protection. The present study aims to assess the immune dynamics of humoral, T-cell response, and influencing factors to stratify individual immunization status up to 10 months after Comirnaty-vaccine administration. Methods: To this aim, we longitudinally evaluated the magnitude and kinetics of both humoral and T-cell responses by serological tests and enzyme-linked immunospot assay at 5 time points. Furthermore, we compared the course over time of the two branches of adaptive immunity to establish an eventual correlation between adaptive responses. Lastly, we evaluated putative influencing factors collected by an anonymized survey administered to all participants through multiparametric analysis. Among 984 healthcare workers evaluated for humoral immunity, 107 individuals were further analyzed to describe SARS-CoV-2-specific T-cell responses. Participants were divided into 4 age groups: <40 and ≥40 years for men, <48 and ≥48 years for women. Furthermore, results were segregated according to SARS-CoV-2-specific serostatus at baseline. Results: The disaggregated evaluation of humoral responses highlighted antibody levels decreased in older subjects. The humoral responses were higher in females than in males (p=0.002) and previously virus-exposed subjects compared to naïve subjects (p<0.001). The vaccination induced a robust SARS-CoV-2 specific T-cell response at early time points in seronegative subjects compared to baseline levels (p<0.0001). However, a contraction was observed 6 months after vaccination in this group (p<0.01). On the other hand, the pre-existing specific T-cell response detected in natural seropositive individuals was longer-lasting than the response of the seronegative subjects, decreasing only 10 months after vaccination. Our data suggest that T-cell reactiveness is poorly impacted by sex and age. Of note, SARS-CoV-2-specific T-cell response was not correlated to the humoral response at any time point. Discussion: These findings suggest prospects for rescheduling vaccination strategies by considering individual immunization status, personal characteristics, and the appropriate laboratory tests to portray immunity against SARS-CoV-2 accurately. Deepening our knowledge about T and B cell dynamics might optimize the decision-making process in vaccination campaigns, tailoring it to each specific immune response.

Evaluation of Synovial Calprotectin by Using a Lateral Flow Test for the Diagnosis of Prosthetic Joint Infections.

The analysis of synovial fluid is a crucial step in the diagnosis of prosthetic joint infections (PJIs). Recently several studies illustrated the efficacy of synovial calprotectin in supporting the diagnosis of PJI. In this study, synovial calprotectin was analyzed by a commercial stool test to explore whether it might accurately predict PJIs. The synovial fluids of 55 patients were analyzed and calprotectin levels were compared to other synovial biomarkers of PJI. Of the 55 synovial flu-ids, 12 patients were diagnosed with PJI and 43 with an aseptic failure of the implant. Specificity, sensitivity, and AUC of calprotectin resulted in 0.944, 0.80, and 0.852 (95%CI: 0.971-1.00), respectively, with a set threshold of 529.5 µg/g. Calprotectin had a statistically relevant correlation with the synovial leucocyte counts (rs = 0.69, p < 0.001) and the percentage of synovial neutrophils (rs = 0.61, p < 0.001). From this analysis, it can be concluded that synovial calprotectin is a valuable biomarker that correlates with other established indicators of local infection, and the use of a commercial lateral flow stool test could be a cost-effective strategy delivering rapid and reliable results and supporting the diagnostic process of PJI.

Relationships between Jumping Performance and Psychological Readiness to Return to Sport 6 Months Following Anterior Cruciate Ligament Reconstruction: A Cross-Sectional Study.

Background: Investigating the relationship between functional capacity and psychological readiness is of paramount importance when planning sport resumption following knee surgery. The aim of this study was to prospectively assess clinical and functional outcomes in athletes 6 months after primary anterior cruciate ligament (ACL) reconstruction and to evaluate whether jumping ability is related to psychological readiness to return to sport following ACL surgery. Methods: Patients who underwent ACL reconstruction were prospectively enrolled and evaluated pre-operatively and 6 months after surgery. Assessment included Lysholm score, International Knee Documentation Committee (IKDC) Subjective Knee Form, Tegner activity level, and the ACL−Return to Sport after Injury (ACL-RSI) scale. Jumping ability was instrumentally assessed by an infrared optical acquisition system using a test battery including mono- and bipodalic vertical jump and a side hop test. Patients were dichotomized by ACL-RSI into two groups: group A (ACL-RSI > 60), and group B (ACL-RSI < 60). Results: Overall, 29 males and two females from the original study group of 37 patients (84%) were available for clinical evaluation. Mean age at surgery was 34.2 years (SD 11.3). Mean body mass index (BMI) was 25.4 (SD 3.7). Mean overall Lysholm, IKDC, and ACL-RSI scores increased from pre-operatively (p < 0.001). No differences in Tegner score were reported (p = 0.161). Similarly, improvement in most variables regarding jumping ability were observed at follow-up (p < 0.05). According to ACL-RSI, 20 subjects were allocated in group A (ACL-RSI > 60), while 11 were allocated in group B (ACL-RSI < 60). A statistically significant difference in favor of patients in group A was recorded for the post-operative Lysholm and Tegner score, as well as Side Hop test LSI level (p < 0.05), while a trend for IKDC was observed without statistical significance (p = 0.065). Conclusions: Patients with higher values of ACL-RSI scores showed better functional and clinical outcomes as well as improved performance 6 months after ACL reconstruction

One-stage vs two-stage bilateral THA in Lombardy: a cost-effectiveness analysis.

BACKGROUND: Total hip arthroplasty (THA) is the most common treatment for primary and secondary end-stage hip osteoarthritis (OA). Almost 20% of all patients undergoing primary THA suffer from bilateral hip OA and, consequently, will need a contralateral procedure to be performed in the following years. The aim of this study is to evaluate the cost-effectiveness and the reliability of one-stage bilateral THA (1-BTHA) compared to two-stage bilateral THA (2-BTHA), in low-risk patients, performed with anterior minimally invasive surgery (AMIS). METHODS: Single patient's costs were obtained by dividing the annual costs report by the number of hospitalizations, considering the diagnosis related group (DRG) of the two procedures. Then, 16 patients undergoing 1-BTHA and 8 undergoing 2-BTHA were examined. Hemoglobin (Hb) values before surgery and before discharge, transfusion rate and the occurrence of post-operative complications were observed. RESULTS: Procedural costs were divided in different subgroups: pre-hospitalization, operating room, hospital stay, post-operative follow-up and other costs. 1-BTHA total costs amount to 5.754,82€, while performing 2-BTHA costs 7.624,32€. However, considering DRG reimbursement, the hospital's profit margin following 1-BTHA is lower than that following 2-BTHA (6.346,18€ versus 9.261,68€). Surgical time was found not to be significantly different between 1-BTHA and 2-BTHA (141,13 ± 26,1 min vs 164,8 ± 44,3 min; p = 0,111). The two groups showed a statistically significant difference in Hb decrease (4,8 ± 1,3 g/dl vs 3,3 ± 0,9; p = 0,001), despite no variances in transfusion rate. No further complications were observed in either group. CONCLUSIONS: This study demonstrates how, in carefully selected patients, 1-BTHA performed with AMIS is a cost-effective and safe technique compared to 2-BTHA, resulting in a shorter OR time, LOS and lower overall costs. LEVEL OF EVIDENCE: III.

Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial.

PURPOSE: Current conservative treatments for knee OA provide limited benefits, with symptoms relief for a short amount of time. Regenerative medicine approaches such as the use of microfragmented adipose tissue (mFAT) showed promising results in terms of durable effects and the possibility to enhance tissue healing and counteract the progression of the pathology. Nevertheless, up to today, the large part of clinical data about mFAT use refers to uncontrolled studies, especially in the surgical setting. The purpose of this study was to evaluate the effectiveness of mFAT applied in association with arthroscopic debridement (AD) for the treatment of knee OA, in terms of symptoms relief and tissue healing. METHODS: This study is a prospective, randomized controlled clinical trial. 78 patients affected by knee OA grade 3-4 according to KL classification were randomly assigned to AD or AD + mFAT treatment groups. Clinical, radiological and serological assessments were performed at 6 months after treatment. Additional clinical evaluation was performed at the end of the study with an average follow-up of 26.1 ± 9.5 months. VAS, KOOS, WOMAC and SF-12 were also collected at both timepoints, KSS only at 6 months. RESULTS: Treatment with AD + mFAT improved functional scores at both 6 months (KOOS-PS: + 11.7 ± 20.2 vs + 24.4 ± 22.5, in AD and AD + mFAT, respectively, p = 0.024; KSS: + 14.9 ± 15.9 vs + 24.8 ± 23.5, in AD and AD + mFAT, respectively, p = 0.046) and 24-month follow-ups (KOOS-PS Functional subscale: - 2.0 ± 3.5 vs - 4.7 ± 4.2, in AD and AD + mFAT, respectively, p = 0.012). Lower T2-mapping scores were obtained in AD + mFAT-treated group in medial and lateral condyle compartments (p < 0.001). Slight increase was observed in the levels of a serum biomarker of cartilage deposition (PIIINP) in both groups at 6-month follow-up (p = 0.037). CONCLUSION: mFAT improves functional outcome and MRI appearance when used in association with AD, therefore supporting its use in the treatment of knee OA in an arthroscopic setting.

Adolescent Idiopathic Scoliosis Surgery: Postoperative Functional Outcomes at 32 Years Mean Follow-Up.

INTRODUCTION: Recent clinical and radiographic studies conducted over short and medium terms have demonstrated positive results in patients undergoing surgery for adolescent idiopathic scoliosis (AIS). However, the absence of long-term data, crucial for comprehending the impact on future quality of life, especially in young patients actively involved in very intense physical activities, remains a gap. This study aims to evaluate long-term functional outcomes in patients who underwent surgery for Adolescent Idiopathic Scoliosis. MATERIAL AND METHODS: Patients meeting specific criteria (diagnosis of AIS, age at surgery between 12 and 18 years, and follow-up of at least 20 years) were identified from a large spine surgery center database. A questionnaire using "Google Form" assessed various outcomes, including Visual Analog Scale (VAS) back, VAS leg, Short Form 12 score (SF-12), Scoliosis Research Society 22 score (SRS-22), incidence of spine revision surgery, postoperative high demanding activities (work and sport), and possible pregnancies was sent to the enrolled patients. The authors analyzed the results regarding all patients included and, moreover, statistical analysis categorized patients into two groups based on the surgical fusion performed: Group 1 (non-instrumented technique according to Hibbs-Risser) and Group 2 (instrumented tecnique according to Cotrel-Dubousset). RESULTS: A total of 63 patients (mean age 47.5 years) were included, with a mean follow-up of 31.9 years. Patients were, in mean, 47.5 years old. Group 1 comprised 42 patients, and Group 2 had 21 patients. Revision surgery was required in 19% of patients, predominantly for implant issues in Group 2 (11.9% vs. 33%, p < 0.05). Overall outcomes were favorable: VAS back = 3.5, VAS leg = 2.5, SRS-22 = 3.5, SF-12 Physical Component Summary = 41.1, SF-12 Mental Component Summary = 46.7, with no significant differences between the group 1 and group 2. At 5-years FU, the non-reoperation rate was higher in the non-instrumented group (97.6% vs. 71.4%, p < 0.001). By means of SRS-22, overall satisfaction was 3.7 ± 1.2 on a maximum scale of 5. More than half of women have successfully completed one pregnancy. Most patients (87.3%) maintained regular work activity. Among sport practioners, half returned to the similar preoperative level. CONCLUSIONS: This study reveals favorable long-term functional results in adolescent idiopathic scoliosis patients after surgical fusion. Mild to moderate back and leg pain were observed, but overall satisfaction, sport participation, and work activity were high. Surgical technique (non-instrumented vs. instrumented) did not significantly impact long-term results, though the instrumented fusion exhibited a higher revision rate.

Epidemiology and Management of Proximal Femoral Fractures in Italy between 2001 and 2016 in Older Adults: Analysis of the National Discharge Registry.

This study aims to determine the annual incidence of proximal femoral fractures in Italy in the period between 2001 and 2016 among older adults, and to describe the trends in the clinical management of these cases. Data were retrieved from the National Hospital Discharge records issued by the Italian Ministry of Health and from the Italian Institute for Statistics. The number of hospitalizations increased between 2001 and 2016, while the age-adjusted yearly incidence decreased from 832.2 per 100,000 individuals to 706.2. The median age was 83 years (IQR 78-88) with a large majority of females (76.6%). The type of fracture varied with age in female subjects, with older women more frequently reporting pertrochanteric fractures. Therapeutic strategies for the different types of fracture depended on patients' age. During the study years, improvements in fracture classification and management strategies were observed, with a clear decreasing trend for non-operative solutions. In conclusion, the number of proximal femur fractures in older adults is growing, even if at a lower rate compared to population aging. The Italian surgical practice changed during the study period towards the implementation of the most recent guidelines.

The Use of Intraventricular Instillation of Vancomycin to Prevent External Ventricular Drainage Related Infection: A Clinical Prospective Study.

BACKGROUND: External ventricular drainage (EVD)-related infection (ERI) represents an important condition with potential high morbidity with significant impact on patient outcomes. Prophylactic systemic antibiotics are routinely administered to patients with EVD, but they do not significantly lower the incidence of ERIs. Intraventricular treatment with vancomycin appeared to be safe and effective, but most reports are case-reports/-series and retrospective studies. METHODS: A prospective non-randomized case-control study was conducted in a consecutive series of 116 patients treated with EVD insertion. The study includes the group of patients treated with intrathecal vancomycin (Group A, 62 patients) compared with the control group treated with daily intravenous cefazolin (Group B, 54 patients). RESULTS: No statistically significant differences were found between the 2 groups with regard to the duration of catheterization and occurrence of ERI during hospitalization. EVD was replaced in 16 cases (25.8%) in group A and in 12 cases (22.2%) in the control group B (P 0.67). Three cases (4.8%) of ERI have been found in group A and 5 (9.3%) in the control group (P = 0.34). All reported cases of infection in group A were caused by gram-negative agents; on the opposite, cases of infections in the control group B were caused above all by gram-positive bacteria with a statistical difference (P = 0.03). CONCLUSIONS: In this first prospective study on this topic, we found that intrathecal Vancomycin administration in EVDs does not reduce the occurrence of ERI compared with intravenous cefazolin prophylaxis, but induces selection of gram-negative bacteria.

Six months SARS-CoV-2 serology in a cohort of mRNA vaccinated subjects over 90 years old.

Ageing is associated with a progressive decline and remodelling of the immune system. Also, the efficacy of COVID-19 vaccines has been observed to depend on subjects' age. The post-vaccination data about patients aged > 90 years old is scarcely represented in the literature. The antibody titre profiles of elderly vaccinated subjects (age > 90 years old) were evaluated and compared with profiles obtained in a younger population (age 23-69 years old). To the best of our knowledge, this is the first report providing post-vaccination serological data in subjects aged 90 + years old. This study suggests that distinct SARS-CoV-2 viral-specific antibody response profiles vary based on anti-N serostatus, age, and sex in the very elderly adults. The data obtained could impact the organisation of the vaccination campaign (i.e., prioritisation strategies, administration of additional doses) and the factors that facilitate intentions to receive the vaccination among elderly adults (i.e., vaccine effectiveness).

Italian Translation, Adaptation, and Validation of the Novel Satisfaction Measure Assessment after Primary Total Joint Arthroplasty: The Goodman Score Questionnaire.

Patient satisfaction after total joint arthroplasties (TJA) represents a key element for the evaluation of surgery success in relation to subjects' needs and expectations. The assessment tools are applied inconsistently throughout the literature, and thus, it is difficult to compare results among different studies. Goodman et al. proposed a standardized questionnaire with strong psychometric properties for the assessment of satisfaction. The present study aims to translate, adapt, and validate the Goodman questionnaire for the Italian population. After translation and back translation, the questionnaire was administrated to 50 patients. Internal consistency, test-retest reliability, floor and ceiling effects, and construct validity were evaluated (correlation with KOOS/HOOS, SF-12 PCS/MCS, EQ-5D). Responsiveness was evaluated with respect to SF-12 PCS improvements. The Italian version of the Goodman score questionnaire demonstrated psychometric properties similar to those of the original version. The translated questionnaire showed good internal consistency (Cronbach's alpha = 0.836) and test-retest reliability (ICC: 0.507). Moderate/strong correlations were observed between the Italian version of the Goodman score and other scores. The score significantly discriminated patients who improved from those who did not improve in SF-12 PCS after treatment. This study provides an adapted and validated Italian version of the Goodman score questionnaire, with psychometric properties similar to those of its original counterpart.

Characterization of Microfragmented Adipose Tissue Architecture, Mesenchymal Stromal Cell Content and Release of Paracrine Mediators.

The use of microfragmented adipose tissue (µFAT) for the treatment of musculoskeletal disorders, especially osteoarthritis (OA), is gaining popularity, following positive results reported in recent case series and clinical trials. Although these outcomes were postulated to rely on paracrine signals, to date, a thorough fingerprint of released molecules is largely missing. The purpose of this study was to first characterize both structure and cell content of unprocessed lipoaspirate (LA) and µFAT, and further identify and frame the array of signaling factors in the context of OA disease, by means of high throughput qRT-PCR for extracellular-vesicle (EV) embedded miRNAs and proteomics for tissue and secreted factors. Cell count showed reduction of blood cells in µFAT, confirmed by histological and flow cytometry analyses, that also showed a conserved presence of structural, endothelial and stromal components and pericytes. In the secretome, 376 and 381 EV-miRNAs in LA and µFAT, respectively, were identified. In particular, most abundant and µFAT upregulated EV-miRNAs were mainly recapitulating those already reported as ASC-EVs-specific, with crucial roles in cartilage protection and M2 macrophage polarization, while only a scarce presence of those related to blood cells emerged. Furthermore, secretome proteomic analysis revealed reduction in µFAT of acute phase factors driving OA progression. Taken together, these results suggest that processing of LA into µFAT allows for removal of blood elements and maintenance of tissue structure and stromal cell populations, and possibly the increase of OA-protective molecular features. Thus, microfragmentation represents a safe and efficient method for the application of adipose tissue properties in the frame of musculoskeletal disorders.

The effects of orthobiologics in the treatment of tendon pathologies: a systematic review of preclinical evidence.

PURPOSE: The aim of this systematic review is to explore the current available knowledge about tendon disorders and orthobiologics derived by preclinical experiments to evaluate their role and efficacy in the different stages and conditions related to the tendon healing processes. METHODS: The systematic review was performed according to the PRISMA guidelines. Different electronic databases (MEDLINE, Web of Science, EMBASE) were searched for studies investigating orthobiologics (PRP and cell-based products from adipose tissue or bone marrow) in animal models or veterinary clinical trials for tendon pathologies (complete/partial tendon ruptures, rotator cuff tears, tendinopathy, enthesis-related injuries). Data regarding the specific product used, the treatment site/pathology, the host and the model were collected. The results were classified into the following categories: histological, biomechanical, molecular and imaging. RESULTS: A large pool of preclinical studies on tendon disorders have been found on platelet-rich plasma (PRP), while data about stromal vascular fraction (SVF) and bone marrow concentrate (BMAC) are still limited and frequently focused on expanded cells, rather than orthobiologics prepared at the point of care. The effect of PRP is related to an acceleration of the healing process, without improvements in the final structure and properties of repaired tendon. Cell-based products have been reported to produce more durable results, but the level of evidence is currently insufficient to draw clear indications. CONCLUSIONS: The preclinical results about orthobiologics applications to tendon pathologies would support the rationale of their clinical use and encourage the performance of clinical trials aimed to confirm these data in human subjects.

Autologous Microfragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: Real-World Data at Two Years Follow-Up.

The purpose of the present study was to assess, prospectively, the safety, clinical effectiveness, and feasibility of a single intra-articular injection of microfragmented adipose tissue in different stages of knee osteoarthritis (OA). The study included patients (aged 18−70 years), affected by OA (Kellgren−Lawrence I-IV). Unselected patients were evaluated before and prospectively after 6, 12, and 24 months from the injection. Visual analog scale (VAS) and knee injury and osteoarthritis outcome score (KOOS) were used for clinical evaluations. A total of 202 patients were eligible. The mean follow-up time in the cohort of patients was 24.5 ± 9.6 months. Total KOOS significantly improved from pre-operative baseline levels to 6-month follow-up (p < 0.001), and again between 6- and 12-month follow-ups (p < 0.001). The VAS showed a prompt reduction at 6 months (p < 0.001 vs. baseline), but then it increased again at 12 months compared to the 6-month assessment (p < 0.001), even though it remained lower than baseline (p < 0.001). At 24 months, patients with KL-IV demonstrated a lower improvement compared to baseline; patients that had undergone previous corticosteroid injections had a greater risk to further injection treatment. The collected clinical results suggest that MFAT may represent a safe and effective treatment for OA symptoms, offering a low-demanding and minimally invasive treatment.

Exploratory assessment of serological tests to determine antibody titer against SARS-CoV-2: Appropriateness and limits.

BACKGROUND: Serological tests can be used to detect antibodies in the serum of subject's after SARS-CoV-2 infection and vaccination. Currently, variability in antibody titers and the availability of a multiplicity of serological tests have made it necessary to highlight their appropriateness and limitations in various diagnostic settings. METHODS: This study is part of Covidiagnostix, a multicenter project aimed at the assessment of the health technology used in SARS-CoV-2 serological tests. Based on data gained from the analysis of over 5000 subjects, a selected number of serum samples, representative of different diagnostic settings, were analyzed first by qualitative immunoassays (IgA, M, and G MILLIPLEX® SARS-CoV-2 tests based on Luminex® ) to define the immunoglobulins serum composition and subsequently by four serological diagnostic tests (Elecsys Anti-SARS-CoV-2 and Elecsys Anti-SARS-CoV-2 S by Roche, SARS-CoV-2 IgG by Siemens Healthcare, and CHORUS SARS-CoV-2 "NEUTRALIZING" Ab by DIESSE). The first WHO International Standard for SARS-CoV-2 was also analyzed using the same methods. RESULTS: This study evaluated the antibody content and titer of the WHO Standard and serum of subjects with/without previous infection and before/after vaccination for SARS-CoV-2. CONCLUSION: The definition of antibodies in the WHO standard and the analysis of serum samples allowed for the identification of the appropriateness of serological tests in each diagnostic setting, increasing the effectiveness of the resulting laboratory data. Furthermore, we found that it would be optimal to produce new international standards against the S1 domain and RBD of the SARS-CoV-2 spike protein for a more effective serological monitoring of vaccination.

Patellofemoral arthroplasty: obesity linked to high risk of revision and progression of medial tibiofemoral osteoarthritis.

PURPOSE: The purpose of this study was to determine the effect of obesity on patient outcome, procedure failure rate and osteoarthritis (OA) progression in the tibiofemoral compartments in a series of isolated patellofemoral arthroplasty (PFA) performed with a third-generation implant. METHODS: The study population was patients who had undergone third-generation PFA at a specialized orthopedic center between 2007 and 2017. Patients were categorized by body-mass index (BMI) as obese (O, BMI > 30 kg/m2) or nonobese (NO, BMI < 30 kg/m2). Preoperative and postoperative clinical and functional assessment included knee range of motion, Knee Society Score (KSS), University of California Los Angeles (UCLA) Activity Score, Tegner Activity Level Scale, and visual analogue scale (VAS) for pain. Preoperative and postoperative radiographs were evaluated for progression of tibiofemoral compartment OA, changes in patellar height and in knee coronal alignment. Multiple logistic regression models were used to assess the effect of BMI on outcomes together with other covariates. RESULTS: A total of 120 PFAs with a mean follow-up of 6.9 ± 2.5 years were included: 25 in the O group and 95 in the NO group. Significant improvement was noted in in knee range of motion (P < 0.001), clinical and functional KSS (P < 0.001), UCLA Activity Score (P < 0.001), Tegner score (P < 0.001) and VAS pain (P < 0.001) without inter-groups differences. Worsening of the medial Kellgren-Lawrence (KL) grade (but not the lateral KL grade) was more frequent in the O than the NO group during the follow-up period (P = 0.014). Failure occurred in 4.2% of NO and in 20% of O group patients; the difference was solely due to failure because of OA progression in the tibiofemoral compartment (16% in the O group). There were no between group differences in the failure rate for any cause other than OA progression (4.2% in the NO group, 4.0% in the O group). CONCLUSIONS: An equal improvement in function after PFA was noted in both obese and nonobese patients; however, the high failure rate due to OA progression in the medial tibiofemoral compartment warrants caution when considering PFA in obese patients.