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    Adults with idiopathic scoliosis improve disability after motor and cognitive rehabilitation: results of a randomised controlled trial

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    Purpose: To evaluate the effects of motor and cognitive rehabilitation on disability in adults with idiopathic scoliosis at lower risk of progression. Methods: 130 adults with idiopathic scoliosis (main curve <35°) were randomly assigned to a 20-week rehabilitation programme consisting of active self-correction, task-oriented exercises and cognitive–behavioural therapy (experimental group, 65 subjects, mean age of 51.6, females 48) or general physiotherapy consisting of active and passive mobilizations, stretching, and strengthening exercises of the spinal muscles (control group, 65 subjects, mean age of 51.7, females 46). Before, at the end, and 12 months after treatment, each participant completed the Oswestry disability index (ODI) (primary outcome), the Tampa scale for kinesiophobia, the pain catastrophizing scale, a pain numerical rating scale, and the Scoliosis Research Society-22 Patient Questionnaire. Radiological (Cobb angle) and clinical deformity (angle of trunk rotation) changes were also investigated. A linear mixed model for repeated measures was used for each outcome. Results: Significant effects of time, group, and time by group interaction were found for all outcome measures (P < 0.001). After training, the primary outcome showed a clinically significant between-group change (12 % points), which was preserved at follow-up. At follow-up, the radiological deformities showed a significant, although not clinically meaningful, between-group difference of 4° in favour of the experimental group. Conclusion: The experimental programme was superior to general physiotherapy in reducing disability of adults with idiopathic scoliosis. Motor and cognitive rehabilitation also led to improvements in dysfunctional thoughts, pain, and quality of life. Changes were maintained for at least 1 year

    Instrumentation failure following pedicle subtraction osteotomy: the role of rod material, diameter, and multi-rod constructs

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    Purpose: Pedicle subtraction osteotomy (PSO) has a complication rate noticeably higher than other corrective surgical techniques used for the treatment of spinal sagittal imbalance. In particular, rod breakage and pseudoarthrosis remain burning issues of this technique. Goal of this study was to investigate the biomechanical performance of several hardware constructs. Methods: The study was performed using two validated finite element models of the lumbosacral spine (L1–S1) incorporating a PSO on L3 and L4, respectively. Both models were instrumented two levels above and below the osteotomy site. Different combinations of materials (Ti6Al4V and Cr–Co) and device configurations (bilateral single vs. double rod, rod diameters of 5 and 6 mm) were investigated. The loading was represented considering a force of 500 N (imposed along the spinal curvature and connecting the vertebral bodies) and pure moments of 7.5 Nm in flexion-extension, lateral bending and axial rotation. The results were evaluated in terms of range of motion (ROM), load, and stresses acting on the instrumentation. Results: A comparable ROM was found for all the models. The simulations showed a different behavior of the devices: increasing the stiffness an 8–19% increase of the load was calculated on the rod. However, the stress on the instrumentation resulted higher on Cr–Co devices and on smaller rods. The highest stress reduction (up to 50%) was ensured using double rod constructs. Conclusions: The bilateral double parallel rods configuration resulted the best to reduce the stresses on the spinal fixators at the osteotomy site. However, the high loads acting on the rods with respect to the physiologic condition could slow down the bone healing at the osteotomy site

    Anterior support reduces the stresses on the posterior instrumentation after pedicle subtraction osteotomy: a finite-element study

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    Study design: The investigation was based on finite-element simulations. Objective: Pedicle subtraction osteotomy (PSO) is an effective but technical demanding surgical technique, associated with a high risk of rod failure. The present study aims at investigating the role of the anterior support in combination with PSO, with a numerical comparative analysis. Methods: An osteotomy was simulated at the L3 level of a lumbosacral spine. An implantation of various combinations of devices for the anterior (1 or 2 cages of different material) and posterior stabilization (1 or 2 rods) was then performed. ROM, loads, and stresses acting on the rods were calculated. Results: A 4â8% reduction of the ROM was obtained introducing one or two cages in the instrumented model. However, the anterior support had only a minor influence on the ROM. The load on the posterior instrumentation decreased up to 8% using one cage and about 15% with two anterior devices. A 20â30% reduction of the stresses on the rods was calculated inserting one cage and up to 50% using two cages. Following the introduction of the anterior support, the greatest stress reduction was observed in the model having two cages and spinal fixators with two rods. Conclusions: The use of cages is crucial to ensure anterior support and decrease loads and stresses on the posterior instrumentation

    Gender differences in the VDR-FokI polymorphism and conventional non-genetic risk factors in association with lumbar spine pathologies in an Italian case-control study

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    Recently, the FokI polymorphism (rs2228570) in the vitamin D receptor gene (VDR) and conventional risk factors were associated with spine disorders in the Italian population, but without gender analysis. Two-hundred and sixty-seven patients (149 males, 118 females) with lumbar spine disorders were assessed by magnetic resonance imaging (MRI) and 254 (127 males, 127 females) asymptomatic controls were enrolled. The exposure to putative risk factors was evaluated and FokI polymorphism was detected by PCR-restriction fragment length polymorphism (PCR-RFLP). An association between lumbar spine pathologies and higher than average age; overweight; family history; lower leisure physical activity; smoking habit; higher number of hours/day exposure to vibration and more sedentary or intense physical job demand was observed in male patients. In contrast, in females, only higher age, overweight, family history and lower leisure physical activity were risk factors. FF genotype was a 2-fold risk factor to develop discopathies and/or osteochondrosis concomitant with disc herniation for both gender patients, while heterozygous Ff was protective for females only. In males only ff genotype was protective for discopathies and/or osteochondrosis and F allele was a 2-fold risk factor for hernia; discopathies; discopathies and/or osteochondrosis. Sex-related differences in voluntary behaviors, exposure to environmental risks and genetic background could be crucial for a gender-differentiated management of patients with spine disorders

    Adipose-Derived Mesenchymal Stromal Cells Treated with Interleukin 1 Beta Produced Chondro-Protective Vesicles Able to Fast Penetrate in Cartilage

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    The study of the miRNA cargo embedded in extracellular vesicles (EVs) released from adipose-derived mesenchymal stromal cells (ASC) preconditioned with IL-1 beta, an inflammatory stimulus driving osteoarthritis (OA), along with EVs-cartilage dynamic interaction represent poorly explored fields and are the purpose of the present research. ASCs were isolated from subcutaneous adipose tissue and EVs collected by ultracentrifugation. Shuttled miRNAs were scored by high-throughput screening and analyzed through bioinformatics approach that predicted the potentially modulated OA-related pathways. Fluorescently labeled EVs incorporation into OA cartilage explants was followed in vitro by time-lapse coherent anti-Stokes Raman scattering; second harmonic generation and two-photon excited fluorescence. After IL-1 beta preconditioning, 7 miRNA were up-regulated, 4 down-regulated, 37 activated and 17 silenced. Bioinformatics allowed to identify miRNAs and target genes mainly involved in Wnt, Notch, TGF beta and Indian hedgehog (IHH) pathways, cartilage homeostasis, immune/inflammatory responses, cell senescence and autophagy. As well, ASC-EVs steadily diffuse in cartilage cells and matrix, reaching a plateau 16 h after administration. Overall, ASCs preconditioned with IL-1 beta allows secretion of EVs embedded with a chondro-protective miRNA cargo, able to fast penetrate in collagen-rich areas of cartilage with tissue saturation in a day. Further functional studies exploring the EVs dose-effects are needed to achieve clinical relevance

    Effect of Sacropelvic Hardware on Axis and Center of Rotation of the Sacroiliac Joint: A Finite Element Study

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    Background: The sacroiliac joint (SIJ) transfers the load of the upper body to the lower extremities while allowing a variable physiological movement among individuals. The axis of rotation (AoR) and center of rotation (CoR) of the SIJ can be evaluated to analyze the stability of the SIJ, including when the sacrum is fixed. The purpose of this study was to determine how load intensity affects the SIJ for the intact model and to characterize how sacropelvic fixation performed with different techniques affects this joint. Methods: Five T10-pelvis models were used: (1) intact model; (2) pedicle screws and rods in T10-S1; (3)pedicle screws and rods in T10-S1, and bilateral S2 alar-iliac screws (S2AI); (4) pedicle screws and rods in T10-S1, bilateral S2AI screws, and triangular implants inserted bilaterally in a sacral alar-iliac trajectory ; and (5) pedicle screws and rods in T10-S1, bilateral S2AI screws, and 2 bilateral triangular implants inserted in a lateral trajectory. Outputs of these models under flexion-extension were compared: AoR and CoR of the SIJ at incremental steps from 0 to 7.5 Nm for the intact model and AoR and CoR of the SIJ for the instrumented models at 7.5 Nm. Results: The intact model was validated against an in vivo study by comparing range of motion and displacement of the sacrum. Increasing the load intensity for the intact model led to an increase of the rotation of the sacrum but did not change the CoR. Comparison among the instrumented models showed that sacropelvic fixation techniques reduced the rotation of the sacrum and stabilized the SIJ, in particular with triangular implants. Conclusion: The study outcomes suggest that increasing load intensity increases the rotation of the sacrum but does not influence the CoR, and use of sacropelvic fixation increases the stability of the SIJ, especially when triangular implants are employed. Clinical relevance: The choice of the instrumentation strategy for sacropelvic fixation affects the stability of the construct in terms of both range of motion and axes of rotation, with direct consequences on the risk of failure and mobilization. Clinical studies should be performed to confirm these biomechanical findings

    A comparative analysis of a disposable and a reusable pedicle screw instrument kit for lumbar arthrodesis: integrating HTA and MCDA

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    Objective: Lumbar arthrodesis is a common surgical technique that consists of the fixation of one or more motion segments with pedicle screws and rods. However, spinal surgery using these techniques is expensive and has a significant impact on the budgets of hospitals and Healthcare Systems. While reusable and disposable instruments for laparoscopic interventions have been studied in literature, no specific information exists regarding instrument kits for lumbar arthrodesis. The aim of the present study was to perform a complete health technology assessment comparing a disposable instrument kit for lumbar arthrodesis (innovative device) with the standard reusable instrument. Methods: A prospective and observational study was implemented, by means of investigation of administrative records of patients undergoing a lumbar arthrodesis surgical procedure. The evaluation was conducted in 2013, over a 12- month time horizon, considering all the procedures carried out using the two technologies. A complete health technology assessment and a multi-criteria decision analysis approach were implemented in order to compare the two alternative technologies. Economic impact (with the implementation of an activity based costing approach), social, ethical, organisational, and technology-related aspects were taken into account. Results: Although the cost analysis produced similar results in the comparison of the two technologies (total cost equal to € 4,279.1 and € 4,242.6 for reusable instrument kit and the disposable one respectively), a significant difference between the two instrument kits was noted, in particular concerning the organisational impact and the patient safety. Conclusions: The replacement of a reusable instrument kit for lumbar arthrodesis, with a disposable one, could improve the management of this kind of devices in hospital settings
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