The biomechanical effect of lumbopelvic distance reduction on reconstruction after total sacrectomy: a comparative finite element analysis of four techniques.

BACKGROUND CONTEXT: Following total sacrectomy, lumbopelvic reconstruction is essential to restore continuity between the lumbar spine and pelvis. However, to achieve long-term clinical stability, bony fusion between the lumbar spine and the pelvic ring is crucial. Reduction of the lumbopelvic distance can promote successful bony fusion. Although many lumbopelvic reconstruction techniques (LPRTs) have been previously analyzed, the biomechanical effect of lumbopelvic distance reduction (LPDR) has not been investigated yet. PURPOSE: To evaluate and compare the biomechanical characteristics of four different LPRTs while considering the effect of LPDR. STUDY DESIGN/SETTING: A comparative finite element (FE) study. METHODS: The FE models following total sacrectomy were developed to analyze four different LPRTs, with and without LPDR. The closed-loop reconstruction (CLR), the sacral-rod reconstruction (SRR), the four-rod reconstruction (FRR), and the improved compound reconstruction (ICR) techniques were analyzed in flexion, extension, lateral bending, and axial rotation. Lumbopelvic stability was assessed through the shift-down displacement and the relative sagittal rotation of L5, while implant safety was evaluated based on the stress state at the bone-implant interface and within the rods. RESULTS: Regardless of LPDR, both the shift-down displacement and relative sagittal rotation of L5 consistently ranked the LPRTs as ICR

Longitudinal CT-based finite element analyses provide objective fracture healing measures in an ovine tibia model.

Measuring the healing status of a bone fracture is important to determine the clinical care a patient receives. Implantable devices can directly and continuously assess the healing status of fracture fixation constructs, while subject-specific virtual biomechanical tests can noninvasively determine callus structural integrity at single time points. Despite their potential for objectification, both methods are not yet integrated into clinical practice with further evidence of their benefits required. This study correlated continuous data from an implantable sensor assessing healing status through implant load monitoring with computer tomography (CT) based longitudinal finite element (FE) simulations in a large animal model. Eight sheep were part of a previous preclinical study utilizing a tibial osteotomy model and equipped with such a sensor. Sensor signal was collected over several months, and CT scans were acquired at six interim time points. For each scan, two FE analyses were performed: a virtual torsional rigidity test of the bone and a model of the bone-implant construct with the sensor. The longitudinal simulation results were compared to the sensor data at corresponding time points and a cohort-specific empirical healing rule was employed. Healing status predicted by both in silico simulations correlated significantly with the sensor data at corresponding time points and correctly identified a delayed and a nonunion in the cohort. The methodology is readily translatable with the potential to be applied to further preclinical or clinical cohorts to find generalizable healing criteria. Virtual mechanical tests can objectively measure fracture healing progressing using longitudinal CT scans.

Beyond the Gut: A Systematic Review and Meta-analysis of Advanced Therapies for Inflammatory Bowel Disease-associated Extraintestinal Manifestations.

BACKGROUND AND AIMS: Extraintestinal manifestations are frequent in patients with inflammatory bowel disease and have a negative impact on quality of life. Currently, however, there is no evidence available to determine which drug should be recommended for these patients beyond anti-TNF treatment. We aimed to analyse the frequency of new extraintestinal manifestations and the behaviour of pre-existing extraintestinal manifestations during advanced therapy. METHODS: We conducted a systematic search on November 15th, 2022, and enrolled randomised controlled trials, cohorts and case series reporting the occurrence and behaviour of extraintestinal manifestations in patients with inflammatory bowel disease receiving advanced therapy (non-TNF inhibitor biologicals and JAK inhibitors). Proportions of new, recurring, worsening, and improving extraintestinal manifestations were calculated with 95% confidence intervals (CIs). The risk of bias was assessed with QUIPS tool. RESULTS: Altogether, 61 studies comprising 13,806 patients reported eligible data on extraintestinal manifestations. The overall proportion of new extraintestinal manifestations was 8% (95%CI, 6% to 12%) during advanced therapy. There was no significant difference between the frequency of new extraintestinal manifestations during vedolizumab and ustekinumab therapy (11%, 95%CI, 8% to 15% versus 6%, 95%CI, 3% to 11%, p=0.166). The improvement of pre-existing manifestations was comparable between vedolizumab and ustekinumab-treated patients, except for joint involvement (42%, 95%CI, 32% to53% versus 54%, 95%CI, 42% to65%, p=0.029). CONCLUSION: The proportion of new extraintestinal manifestations was low during advanced therapy. Furthermore, the improvement of pre-existing manifestations was comparable between advanced therapies, except for pre-existing joint manifestations.

The Semmelweis Study: a longitudinal occupational cohort study within the framework of the Semmelweis Caring University Model Program for supporting healthy aging.

The Semmelweis Study is a prospective occupational cohort study that seeks to enroll all employees of Semmelweis University (Budapest, Hungary) aged 25 years and older, with a population of 8866 people, 70.5% of whom are women. The study builds on the successful experiences of the Whitehall II study and aims to investigate the complex relationships between lifestyle, environmental, and occupational risk factors, and the development and progression of chronic age-associated diseases. An important goal of the Semmelweis Study is to identify groups of people who are aging unsuccessfully and therefore have an increased risk of developing age-associated diseases. To achieve this, the study takes a multidisciplinary approach, collecting economic, social, psychological, cognitive, health, and biological data. The Semmelweis Study comprises a baseline data collection with open healthcare data linkage, followed by repeated data collection waves every 5 years. Data are collected through computer-assisted self-completed questionnaires, followed by a physical health examination, physiological measurements, and the assessment of biomarkers. This article provides a comprehensive overview of the Semmelweis Study, including its origin, context, objectives, design, relevance, and expected contributions.

Knot holding capacity of two different high-strength sutures-a biomechanical analysis.

PURPOSE: The number of seven required throws per knot was previously reported as providing sufficient security against slippage. A novel high-strength suture featuring dynamic tightening may allow for throw number reduction without compromising stability. The aims of this study were to (1) investigate the influence of the throw number and the effect of different ambient conditions on the knot security of two different high-strength sutures, and (2) compare their biomechanical competence. METHODS: Two sutures (FiberWire (FW) and DynaCord (DC)) were considered for preparing alternating surgical knots. The specimens were stratified for exposure to different media during biomechanical testing-namely air (dry), saline solution (wet), and fat (fatty-wet). A monotonic tensile ramp loading to failure was applied in each test run. For each suture and ambient condition, seven specimens with three to seven throws each were tested (n = 7), evaluating their slippage and ultimate force to failure. The minimum number of throws preventing suture unraveling was determined for each suture type and condition. RESULTS: For each suture type and condition, failure occurred via rupture in all specimens for the following minimum number of throws: FW-dry-7, wet-7, fatty-wet-7; DC-dry-6, wet-4, fatty-wet-5. When applying seven throws, FW demonstrated significantly larger slippage (6.5 ± 2.2 mm) versus DC (3.5 ± 0.4 mm) in wet (p = 0.004) but not in dry and fatty-wet conditions (p ≥ 0.313). CONCLUSIONS: The lower number of throws providing knot security of DC versus FW in the more realistic wet and fatty-wet conditions indicates that the novel DC suture may allow to decrease the foreign body volume and save surgical time without compromising the biomechanical competence.

myHealthHub for older adult inpatients to reduce loneliness, and improve patient engagement and mental health: protocol of a pilot randomized controlled trial.

OBJECTIVES: Older Canadian adults make up 85% of hospital stays which are associated with increased loneliness, stress, anxiety, and/or depression. There is a need for novel approaches to reduce loneliness and mental health outcomes in older adult hospital inpatients to prevent further strain on an already overwhelmed healthcare system. METHODS: This is a pilot randomized controlled trial (RCT) exploring the efficacy of a bedside multimodal interaction system, myHealthHub, on loneliness, quality of life (QOL), patient engagement, and other mental health outcomes compared to an active control group in older adult inpatients (n = 60) from baseline to 5-days. Qualitative analyses will be conducted through semi-structured interviews with older adults (n = 8-10) and hospital staff, nurses, and clinicians (n = 4-5) facilitating the service to evaluate patient engagement and experience with myHealthHub. RESULTS: Not applicable. CONCLUSION: This novel pilot clinical trial will obtain preliminary data on the efficacy of myHealthHub in reducing loneliness, QOL, patient engagement, and mental health outcomes in older adult inpatients. If successful, this could provide a potential means to improve patient experience in hospitals and reduce the burden and additional expense on the healthcare system.

On the importance of accurate elasto-plastic material properties in simulating plate osteosynthesis failure.

Background: Plate osteosynthesis is a widely used technique for bone fracture fixation; however, complications such as plate bending remain a significant clinical concern. A better understanding of the failure mechanisms behind plate osteosynthesis is crucial for improving treatment outcomes. This study aimed to develop finite element (FE) models to predict plate bending failure and validate these against in vitro experiments using literature-based and experimentally determined implant material properties. Methods: Plate fixations of seven cadaveric tibia shaft fractures were tested to failure in a biomechanical setup with various implant configurations. FE models of the bone-implant constructs were developed from computed tomography (CT) scans. Elasto-plastic implant material properties were assigned using either literature data or the experimentally derived data. The predictive capability of these two FE modelling approaches was assessed based on the experimental ground truth. Results: The FE simulations provided quantitatively correct prediction of the in vitro cadaveric experiments in terms of construct stiffness [concordance correlation coefficient (CCC) = 0.97, standard error of estimate (SEE) = 23.66, relative standard error (RSE) = 10.3%], yield load (CCC = 0.97, SEE = 41.21N, RSE = 7.7%), and maximum force (CCC = 0.96, SEE = 35.04, RSE = 9.3%), when including the experimentally determined material properties. Literature-based properties led to inferior accuracies for both stiffness (CCC = 0.92, SEE = 27.62, RSE = 19.6%), yield load (CCC = 0.83, SEE = 46.53N, RSE = 21.4%), and maximum force (CCC = 0.86, SEE = 57.71, RSE = 14.4%). Conclusion: The validated FE model allows for accurate prediction of plate osteosynthesis construct behaviour beyond the elastic regime but only when using experimentally determined implant material properties. Literature-based material properties led to inferior predictability. These validated models have the potential to be utilized for assessing the loads leading to plastic deformation in vivo, as well as aiding in preoperative planning and postoperative rehabilitation protocols.

Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique.

A novel in situ customizable osteosynthesis technique, Bonevolent™ AdhFix, demonstrates promising biomechanical properties under the expertise of a single trained operator. This study assesses inter- and intra-surgeon biomechanical variability and usability of the AdhFix osteosynthesis platform. Six surgeons conducted ten osteosyntheses on a synthetic bone fracture model after reviewing an instruction manual and completing one supervised osteosynthesis. Samples underwent 4-point bending tests at a quasi-static loading rate, and the maximum bending moment (BM), bending stiffness (BS), and AdhFix cross-sectional area (CSA: mm²) were evaluated. All constructs exhibited a consistent appearance and were suitable for biomechanical testing. The mean BM was 2.64 ± 0.57 Nm, and the mean BS was 4.35 ± 0.44 Nm/mm. Statistically significant differences were observed among the six surgeons in BM (p < 0.001) and BS (p = 0.004). Throughout ten trials, only one surgeon demonstrated a significant improvement in BM (p < 0.025), and another showed a significant improvement in BS (p < 0.01). A larger CSA corresponded to a statistically significantly higher value for BM (p < 0.001) but not for BS (p = 0.594). In conclusion, this study found consistent biomechanical stability both across and within the surgeons included, suggesting that the AdhFix osteosynthesis platform can be learned and applied with minimal training and, therefore, might be a clinically viable fracture fixation technique. The variability in BM and BS observed is not expected to have a clinical impact, but future clinical studies are warranted.

Relative lateral wall thickness is an improved predictor for postoperative lateral wall fracture after trochanteric femoral fracture osteosynthesis.

Lateral wall thickness is a known predictor for postoperative stability of trochanteric femoral fractures and occurrence of secondary lateral wall fractures. Currently, the AO/OTA classification relies on the absolute lateral wall thickness (aLWT) to distinguish between stable A1.3 and unstable A2.1 fractures that does not take interpersonal patient differences into account. Thus, a more individualized and accurate measure would be favorable. Therefore, we proposed and validated a new patient-specific measure-the relative lateral wall thickness (rLWT)-to consider individualized measures and hypothesized its higher sensitivity and specificity compared with aLWT. First, in 146 pelvic radiographs of patients without a trochanteric femoral fracture, the symmetry of both caput-collum-diaphyseal angle (CCD) and total trochanteric thickness (TTT) was assessed to determine whether the contralateral side can be used for rLWT determination. Then, data of 202 patients were re-evaluated to compare rLWT versus previously published aLWT. Bilateral symmetry was found for both CCD and TTT (p ≥ 0.827), implying that bone morphology and geometry of the contralateral intact side could be used to calculate rLWT. Validation revealed increased accuracy of the rLWT compared with the gold standard aLWT, with increased specificity by 3.5% (Number Needed to Treat = 64 patients) and sensitivity by 1% (Number Needed to Treat = 75 patients). The novel rLWT is a more accurate and individualized predictor of secondary lateral wall fractures compared with the standard aLWT. This study established the threshold of 50.5% rLWT as a reference value for predicting fracture stability in trochanteric femoral fractures.

Treatment of Metaphyseal Defects in Plated Proximal Humerus Fractures with a New Augmentation Technique-A Biomechanical Cadaveric Study.

Background and Objectives: Unstable proximal humerus fractures (PHFs) with metaphyseal defects-weakening the osteosynthesis construct-are challenging to treat. A new augmentation technique of plated complex PHFs with metaphyseal defects was recently introduced in the clinical practice. This biomechanical study aimed to analyze the stability of plated unstable PHFs augmented via implementation of this technique versus no augmentation. Materials and Methods: Three-part AO/OTA 11-B1.1 unstable PHFs with metaphyseal defects were created in sixteen paired human cadaveric humeri (average donor age 76 years, range 66-92 years), pairwise assigned to two groups for locked plate fixation with identical implant configuration. In one of the groups, six-milliliter polymethylmethacrylate bone cement with medium viscosity (seven minutes after mixing) was placed manually through the lateral window in the defect of the humerus head after its anatomical reduction to the shaft and prior to the anatomical reduction of the greater tuberosity fragment. All specimens were tested biomechanically in a 25° adduction, applying progressively increasing cyclic loading at 2 Hz until failure. Interfragmentary movements were monitored by motion tracking and X-ray imaging. Results: Initial stiffness was not significantly different between the groups, p = 0.467. Varus deformation of the humerus head fragment, fracture displacement at the medial humerus head aspect, and proximal screw migration and cut-out were significantly smaller in the augmented group after 2000, 4000, 6000, 8000 and 10,000 cycles, p ≤ 0.019. Cycles to 5° varus deformation of the humerus head fragment-set as a clinically relevant failure criterion-and failure load were significantly higher in the augmented group, p = 0.018. Conclusions: From a biomechanical standpoint, augmentation with polymethylmethacrylate bone cement placed in the metaphyseal humerus head defect of plated unstable PHFs considerably enhances fixation stability and can reduce the risk of postoperative complications.

Complication Pattern of Sacral Primary Tumor Resection: A Study on the Risk Factors of Surgical Site Infection and Bowel or Bladder Dysfunction and Their Associations with Length of Hospital Stay.

STUDY DESIGN: Retrospective open cohort study. PURPOSE: The current study aimed to explore the pattern of complications after primary sacral tumor resection, to investigate the possible effect of several perioperative parameters on the development of complications, and to identify which complications are associated with the length of hospital stay (LOS). OVERVIEW OF LITERATURE: Primary sacral tumor (pST) resection is associated with a high complication rate. However, the number of studies on these complications and their effect on LOS is limited. METHODS: The clinical data of 140 patients with pST surgeries and 106 subsequent patients with local recurrence surgeries in four subgroups (index surgery, local recurrence surgery, malignant, and benign tumor) were prospectively collected and analyzed. The prognostic value of several perioperative factors on the development of surgical site infection (SSI), bowel and bladder dysfunction (BBD), and LOS was investigated using the logistic and linear regression models. RESULTS: The overall complication rates were 61.2% after index surgeries and 50.9% after local recurrence surgeries. The most frequent complications were SSI, vegetative dysfunction, urinary tract infections, and neurological deterioration. Age >55 years, malignant tumors, and red blood cell transfusion had a predictive effect on the development of SSI in the logistic model (p<0.01, R2=0.43). Bilateral S2 or S3 resection commonly caused postoperative BBD (chi-square test=62.5, degrees of freedom=4, p<0.001). In the multiple linear regression model, wound dehiscence, BBD, systemic and urinary tract infection, cerebrospinal fluid leak, and neurologic deterioration were associated with a significantly long LOS (p<0.01, R2=0.62). CONCLUSIONS: Surgical resection of pSTs has a high complication rate. Its common complications are SSI and BBD, both of which can have a significant influence on global therapeutic outcome. Malignant tumor diagnosis, old age, and red blood cell transfusion can remarkably increase the risk of SSI. Further, the development of BBD is significantly associated with the number of resected sacral nerve roots. By decreasing perioperative complications, LOS can decrease significantly.

Substitutional semi-rigid osteosynthesis technique for treatment of unstable pubic symphysis injuries: a biomechanical study.

BACKGROUND/PURPOSE: The surgical fixation of a symphyseal diastasis in partially or fully unstable pelvic ring injuries is an important element when stabilizing the anterior pelvic ring. Currently, open reduction and internal fixation (ORIF) by means of plating represents the gold standard treatment. Advances in percutaneous fixation techniques have shown improvements in blood loss, surgery time, and scar length. Therefore, this approach should also be adopted for treatment of symphyseal injuries. The technique could be important since failure rates, following ORIF at the symphysis, remain unacceptably high. The aim of this biomechanical study was to assess a semi-rigid fixation technique for treatment of such anterior pelvic ring injuries versus current gold standards of plate osteosynthesis. METHODS: An anterior pelvic ring injury type III APC according to the Young and Burgess classification was simulated in eighteen composite pelvises, assigned to three groups (n = 6) for fixation with either a single plate, two orthogonally positioned plates, or the semi-rigid technique using an endobutton suture implant. Biomechanical testing was performed in a simulated upright standing position under progressively increasing cyclic loading at 2 Hz until failure or over 150,000 cycles. Relative movements between the bone segments were captured by motion tracking. RESULTS: Initial quasi-static and dynamic stiffness, as well as dynamic stiffness after 100,000 cycles, was not significantly different among the fixation techniques (p ≥ 0.054).). The outcome measures for total displacement after 20,000, 40,000, 60,000, 80,000, and 100,000 cycles were associated with significantly higher values for the suture technique versus double plating (p = 0.025), without further significant differences among the techniques (p ≥ 0.349). Number of cycles to failure and load at failure were highest for double plating (150,000 ± 0/100.0 ± 0.0 N), followed by single plating (132,282 ± 20,465/91.1 ± 10.2 N), and the suture technique (116,088 ± 12,169/83.0 ± 6.1 N), with significantly lower values in the latter compared to the former (p = 0.002) and no further significant differences among the techniques (p ≥ 0.329). CONCLUSION: From a biomechanical perspective, the semi-rigid technique for fixation of unstable pubic symphysis injuries demonstrated promising results with moderate to inferior behaviour compared to standard plating techniques regarding stiffness, cycles to failure and load at failure. This knowledge could lay the foundation for realization of further studies with larger sample sizes, focusing on the stabilization of the anterior pelvic ring.

Complication Pattern After Percutaneous Cement Discoplasty: Identification of Factors Influencing Reoperation and Length of Hospital Stay.

OBJECTIVE: Percutaneous cement discoplasty (PCD) was introduced to treat symptomatic vertical instability of the lumbar spine in a minimally invasive way. The aim of the present study was to analyze the complication pattern after PCD and to identify factors that predict the chance of cement leakage, reoperation, and length of hospital stay (LOS). METHODS: patients were treated with PCD within the study period. Clinical features and complications were analyzed by applying descriptive statistics, whereas perioperative factors predictive of cement leakage, reoperation, and LOS were identified by regression models. RESULTS: Cement leakage rate was 30.4% in the total cohort; however, only fifth of them were symptomatic. Cement leakage itself did not have a significant influence on clinical outcome. Other complications and nonsurgical adverse events were registered only in 2.0% of cases. Age, subcutaneous fat tissue thickness, low viscosity cement, lower level of surgeon's experience and the number of operated levels were identified as risk factors of cement leakage (P < 0.01; c-index = 0.836). Type of procedure, Charlson comorbidity score, reoperation, and nonsurgical adverse events significantly increased the LOS (P < 0.01). Cement leakage, early surgical practice, and increased subcutaneous fat tissue thickness were risk factors for reoperation (P < 0.01; c-index = 0.72). CONCLUSIONS: PCD is a relatively safe and effective procedure for treating spinal instability caused by advanced-stage disc degeneration characterized by vacuum phenomenon. Cement leakage is not uncommon but is only a radiologic complication without clinical consequences in most cases. On the other hand, it can increase the LOS and is a significant risk factor for reoperation.

Fatigue life of 3D-printed porous titanium dental implants predicted by validated finite element simulations.

Introduction: Porous dental implants represent a promising strategy to reduce failure rate by favoring osseointegration or delivering drugs locally. Incorporating porous features weakens the mechanical capacity of an implant, but sufficient fatigue strength must be ensured as regulated in the ISO 14801 standard. Experimental fatigue testing is a costly and time-intensive part of the implant development process that could be accelerated with validated computer simulations. This study aimed at developing, calibrating, and validating a numerical workflow to predict fatigue strength on six porous configurations of a simplified implant geometry. Methods: Mechanical testing was performed on 3D-printed titanium samples to establish a direct link between endurance limit (i.e., infinite fatigue life) and monotonic load to failure, and a finite element model was developed and calibrated to predict the latter. The tool was then validated by predicting the fatigue life of a given porous configuration. Results: The normalized endurance limit (10% of the ultimate load) was the same for all six porous designs, indicating that monotonic testing was a good surrogate for endurance limit. The geometry input of the simulations influenced greatly their accuracy. Utilizing the as-designed model resulted in the highest prediction error (23%) and low correlation between the estimated and experimental loads to failure (R2 = 0.65). The prediction error was smaller when utilizing specimen geometry based on micro computed tomography scans (14%) or design models adjusted to match the printed porosity (8%). Discussion: The validated numerical workflow presented in this study could therefore be used to quantitatively predict the fatigue life of a porous implant, provided that the effect of manufacturing on implant geometry is accounted for.

Biomechanical performance of a novel light-curable bone fixation technique.

Traumatic bone fractures are often debilitating injuries that may require surgical fixation to ensure sufficient healing. Currently, the most frequently used osteosynthesis materials are metal-based; however, in certain cases, such as complex comminuted osteoporotic fractures, they may not provide the best solution due to their rigid and non-customizable nature. In phalanx fractures in particular, metal plates have been shown to induce joint stiffness and soft tissue adhesions. A new osteosynthesis method using a light curable polymer composite has been developed. This method has demonstrated itself to be a versatile solution that can be shaped by surgeons in situ and has been shown to induce no soft tissue adhesions. In this study, the biomechanical performance of AdhFix was compared to conventional metal plates. The osteosyntheses were tested in seven different groups with varying loading modality (bending and torsion), osteotomy gap size, and fixation type and size in a sheep phalanx model. AdhFix demonstrated statistically higher stiffnesses in torsion (64.64 ± 9.27 and 114.08 ± 20.98 Nmm/° vs. 33.88 ± 3.10 Nmm/°) and in reduced fractures in bending (13.70 ± 2.75 Nm/mm vs. 8.69 ± 1.16 Nmm/°), while the metal plates were stiffer in unreduced fractures (7.44 ± 1.75 Nm/mm vs. 2.70 ± 0.72 Nmm/°). The metal plates withstood equivalent or significantly higher torques in torsion (534.28 ± 25.74 Nmm vs. 614.10 ± 118.44 and 414.82 ± 70.98 Nmm) and significantly higher bending moments (19.51 ± 2.24 and 22.72 ± 2.68 Nm vs. 5.38 ± 0.73 and 1.22 ± 0.30 Nm). This study illustrated that the AdhFix platform is a viable, customizable solution that is comparable to the mechanical properties of traditional metal plates within the range of physiological loading values reported in literature.

Efficacy of a 4-Antigen Staphylococcus aureus Vaccine in Spinal Surgery: The STaphylococcus aureus suRgical Inpatient Vaccine Efficacy (STRIVE) Randomized Clinical Trial.

BACKGROUND: Staphylococcus aureus is a global pathogen that is frequently responsible for healthcare-associated infections, including surgical site infections (SSIs). Current infection prevention and control approaches may be limited, with S. aureus antibiotic resistance remaining problematic. Thus, a vaccine to prevent or reduce S. aureus infection is critically needed. We evaluated the efficacy and safety of an investigational 4-antigen S. aureus vaccine (SA4Ag) in adults undergoing elective open posterior spinal fusion procedures with multilevel instrumentation. METHODS: In this multicenter, site-level, randomized, double-blind trial, patients aged 18-85 years received a single dose of SA4Ag or placebo 10-60 days before surgery. SA4Ag efficacy in preventing postoperative S. aureus bloodstream infection and/or deep incisional or organ/space SSIs was the primary end point. Safety evaluations included local reactions, systemic events, and adverse events (AEs). Immunogenicity and colonization were assessed. RESULTS: Study enrollment was halted when a prespecified interim efficacy analysis met predefined futility criteria. SA4Ag showed no efficacy (0.0%) in preventing postoperative S. aureus infection (14 cases in each group through postoperative day 90), despite inducing robust functional immune responses to each antigen compared with placebo. Colonization rates across groups were similar through postoperative day 180. Local reactions and systemic events were mostly mild or moderate in severity, with AEs reported at similar frequencies across groups. CONCLUSIONS: In patients undergoing elective spinal fusion surgical procedures, SA4Ag was safe and well tolerated but, despite eliciting substantial antibody responses that blocked key S. aureus virulence mechanisms, was not efficacious in preventing S. aureus infection. Clinical Trials Registration. NCT02388165.

Mechanical assessment of two hybrid plate designs for pancarpal canine arthrodesis under cyclic loading.

Pancarpal canine arthrodesis (PCA) sets immobilization of all three carpal joints via dorsal plating to result in bony fusion. Whereas the first version of the plate uses a round hole (RH) for the radiocarpal (RC) screw region, its modification into an oval hole (OH) in a later version improves versatility in surgical application. The aim of this study was to mechanically investigate the fatigue life of the PCA plate types implementing these two features-PCA-RH and PCA-OH. Ten PCA-RH and 20 PCA-OH stainless steel (316LVM) plates were assigned to three study groups (n = 10). All plates were pre-bent at 20° and fixed to a canine forelimb model with simulated radius, RC bone and third metacarpal bone. The OH plates were fixed with an RC screw inserted either most proximal (OH-P) or most distal (OH-D). All specimens were cyclically tested at 8 Hz under 320 N loading until failure. Fatigue life outcome measures were cycles to failure and failure mode. Cycles to failure were higher for RH plate fixation (695,264 ± 344,023) versus both OH-P (447,900 ± 176,208) and OH-D (391,822 ± 165,116) plate configurations, being significantly different between RH and OH-D, p = 0.03. No significant difference was detected between OH-P and OH-D configurations, p = 0.09. Despite potential surgical advantages, the shorter fatigue life of the PCA-OH plate design may mitigate its benefits compared to the plate design with a round radiocarpal screw hole. Moreover, the failure risk of plates with an oval hole is increased regardless from the screw position in this hole. Based on these findings, the PCA plate with the current oval radiocarpal screw hole configuration cannot be recommended for clinical use.

Can semirigid fixation of the rostral instrumented segments prevent proximal junctional kyphosis in the case of long thoracolumbar fusions? A finite element study.

OBJECTIVE: Proximal junctional kyphosis (PJK) is a relatively common complication following long instrumented posterior spinal fusion. Although several risk factors have been identified in the literature, previous biomechanical studies suggest that one of the leading causes is the sudden change in mobility between the instrumented and noninstrumented segments. The current study aims to assess the biomechanical effect of 1 rigid and 2 semirigid fixation techniques (SFTs) on developing PJK. METHODS: Four T7-L5 finite element (FE) models were developed: 1) intact spine; 2) 5.5-mm titanium rod from T8 to L5 (titanium rod fixation [TRF]); 3) multiple rods from T8 to T9 connected with titanium rod from T9 to L5 (multiple-rod fixation [MRF]); and 4) polyetheretherketone rod from T8 to T9 connected with titanium rod from T9 to L5 (PEEK rod fixation [PRF]). A modified multidirectional hybrid test protocol was used. First, a pure bending moment of 5 Nm was applied to measure the intervertebral rotation angles. Second, the TRF technique's displacement from the first loading step was applied to the instrumented FE models to compare the pedicle screw stress values in the upper instrumented vertebra (UIV). RESULTS: In the load-controlled step, at the upper instrumented segment, the intervertebral rotation values relative to TRF increased by 46.8% and 99.2% for flexion, by 43.2% and 87.7% for extension, by 90.1% and 137% for lateral bending, and by 407.1% and 585.2% for axial rotation, in the case of MRF and PRF, respectively. In the displacement-controlled step, maximum pedicle screw stress values at the UIV level were highest in the case of TRF (37.26 MPa, 42.13 MPa, 44.4 MPa, and 44.59 MPa for flexion, extension, lateral bending, and axial rotation, respectively). Compared to TRF, in the case of MRF and PRF, the screw stress values were reduced by 17.3% and 27.7% for flexion, by 26.6% and 36.7% for extension, by 6.8% and 34.3% for lateral bending, and by 49.1% and 59.8% for axial rotation, respectively. CONCLUSIONS: FE analysis has shown that the SFTs increase the mobility at the upper instrumented segment and therefore provide a more gradual transition in motion between the instrumented and rostral noninstrumented segments of the spine. In addition, SFTs decrease the screw loads at the UIV level and hence could help reduce the risk for PJK. However, further investigations are recommended to evaluate the long-term clinical usefulness of these techniques.

Evaluation of Cannulated Compression Headless Screw (CCHS) as an alternative implant in comparison to standard S1-S2 screw fixation of the posterior pelvis ring: a biomechanical study.

BACKGROUND/PURPOSE: Posterior pelvis ring injuries represent typical high-energy trauma injuries in young adults. Joint stabilization with two cannulated sacroiliac (SI) screws at the level of sacral vertebrae S1 and S2 is a well-established procedure. However, high failure- and implant removal (IR) rates have been reported. Especially, the washer recovery can pose the most difficult part of the IR surgery, which is often associated with complications. The aim of this biomechanical study was to evaluate the stability of S1-S2 fixation of the SI joint using three different screw designs. METHODS: Eighteen artificial hemi-pelvises were assigned to three groups (n = 6) for SI joint stabilization through S1 and S2 corridors using either two 7.5 mm cannulated compression headless screws (group CCH), two 7.3 mm partially threaded SI screws (group PT), or two 7.3 mm fully threaded SI screws (group FT). An SI joint dislocation injury type III APC according to the Young and Burgess classification was simulated before implantation. All specimens were biomechanically tested to failure in upright standing position under progressively increasing cyclic loading. Interfragmentary and bone-implant movements were captured via motion tracking and evaluated at four time points between 4000 and 7000 cycles. RESULTS: Combined interfragmentary angular displacement movements in coronal and transverse plane between ilium and sacrum, evaluated over the measured four time points, were significantly bigger in group FT versus both groups CCH and PT, p ≤ 0.047. In addition, angular displacement of the screw axis within the ilium under consideration of both these planes was significantly bigger in group FT versus group PT, p = 0.038. However, no significant differences were observed among the groups for screw tip cutout movements in the sacrum, p = 0.321. Cycles to failure were highest in group PT (9885 ± 1712), followed by group CCH (9820 ± 597), and group FT (7202 ± 1087), being significantly lower in group FT compared to both groups CCH and PT, p ≤ 0.027. CONCLUSION: From a biomechanical perspective, S1-S2 SI joint fixation using two cannulated compression headless screws or two partially threaded SI screws exhibited better interfragmentary stability compared to two fully threaded SI screws. The former can therefore be considered as a valid alternative to standard SI screw fixation in posterior pelvis ring injuries. In addition, partially threaded screw fixation was associated with less bone-implant movements versus fully threaded screw fixation. Further human cadaveric biomechanical studies with larger sample size should be initiated to understand better the potential of cannulated compression headless screw fixation for the therapy of the injured posterior pelvis ring in young trauma patients.

Statistical Morphology and Fragment Mapping of Complex Proximal Humeral Fractures.

Background and Objectives: Proximal humerus fractures (PHFs) are common in the elderly, but the treatment results are often poor. A clear understanding of fracture morphology and distribution of cortical bone loss is important for improved surgical decision making, operative considerations, and new implant designs. The aim of this study was to develop a 3D segmentation fracture mapping technique to create a statistical description of the spatial pattern and cortical bone loss of complex PHFs. Materials and Methods: Fifty clinical computed tomography (CT) scans of complex PHFs and their contralateral intact shoulders were collected. In-house software was developed for semi-automated segmentation and fracture line detection and was combined with manual fracture reduction to the contralateral template in a commercial software. A statistical mean model of these cases was built and used to describe probability maps of the fracture lines and cortical fragments. Results: The fracture lines predominantly passed through the surgical neck and between the tuberosities and tendon insertions. The superior aspects of the tuberosities were constant fragments where comminution was less likely. Some fracture lines passed through the bicipital sulcus, but predominantly at its edges and curving around the tuberosities proximally and distally. Conclusions: A comprehensive and systematic approach was developed for processing clinical CT images of complex fractures into fracture morphology and fragment probability maps and applied on PHFs. This information creates an important basis for better understanding of fracture morphology that could be utilized in future studies for surgical training and implant design.