Disability and Recurrent Stroke Among Participants in Stroke Prevention Trials.

Importance: Stroke secondary prevention trials have disproportionately enrolled participants with mild or no disability. The impact of this bias remains unclear. Objective: To investigate the association between poststroke disability and the rate of recurrent stroke during long-term follow up. Design, Setting, and Participants: This cohort study is a post hoc analysis of the Prevention Regimen For Effectively Avoiding Second Strokes (PRoFESS) and Insulin Resistance Intervention After Stroke (IRIS) secondary prevention clinical trial datasets. PRoFESS enrolled patients from 2003 to 2008, and IRIS enrolled patients from 2005 to 2015. Data were analyzed from September 23, 2023, to May 16, 2024. Exposure: The exposure was poststroke functional status at study baseline, defined as modified Rankin Scale (mRS; range, 0-5; higher score indicates more disability) score of 0 vs 1 to 2 vs 3 or greater. Main Outcomes and Measures: The primary outcome was recurrent stroke. The secondary outcome was major cardiovascular events (MACE), defined as recurrent stroke, myocardial infarction, new or worsening heart failure, or vascular death. Results: A total of 20 183 PRoFESS participants (mean [SD] age, 66.1 [8.5] years; 12 931 [64.1%] male) and 3265 IRIS participants (mean [SD] age, 62.7 [10.6] years; 2151 [65.9%] male) were included. The median (IQR) follow-up was 2.4 (1.9-3.0) years in PRoFESS and 4.7 (3.2-5.0) years in IRIS. In PRoFESS, the recurrent stroke rate was 7.2%, among patients with an mRS of 0, 8.7% among patients with an mRS of 1 or 2, and 10.6% among patients with an mRS of 3 or greater (χ22 = 27.1; P < .001); in IRIS the recurrent stroke rate was 6.4% among patients with an mRS of 0, 9.0% among patients with an mRS of 1 or 2, and 11.7% among patients with an mRS of 3 or greater (χ22 = 11.1; P < .001). The MACE rate was 10.1% among patients with an mRS of 0, 12.2% among patients with an mRS of 1 or 2, and 17.2% among patients with an mRS of 3 or greater (χ22 = 103.4; P < .001) in PRoFESS and 10.9% among patients with an mRS of 0, 13.3% among patients with an mRS of 1 or 2, and 15.3% among patients with an mRS of 3 or greater (χ22 = 5.8; P = .06) in IRIS. Compared with patients with an mRS of 0, patients with an mRS of 3 or greater had increased hazard for recurrent stroke in PRoFESS (hazard ratio [HR], 1.63; 95% CI, 1.38-1.92; P < .001) and in IRIS (HR, 1.91; 95% CI, 1.28-2.86; P = .002). There was also increased hazard for MACE in PRoFESS (HR, 1.90; 95% CI, 1.66-2.18; P < .001) and in IRIS (HR, 1.45; 95% CI, 1.03-2.03; P = .03). Conclusions and Relevance: This cohort study found that higher baseline poststroke disability was associated with increased rates of recurrent stroke and MACE. Including more patients with greater baseline disability in stroke prevention trials may improve the statistical power and generalizability of these studies.

Impact of Poverty on Stroke Recurrence: A Population-Based Study.

BACKGROUND AND OBJECTIVES: Poverty is associated with greater stroke incidence. The relationship between poverty and stroke recurrence is less clear. METHODS: In this population-based study, incident strokes within the Greater Cincinnati/Northern Kentucky region were ascertained during the 2015 study period and followed up for recurrence until December 31, 2018. The primary exposure was neighborhood socioeconomic status (nSES), defined by the percentage of households below the federal poverty line in each census tract in 4 categories (≤5%, >5%-10%, >10%-25%, >25%). Poisson regression models provided recurrence rate estimates per 100,000 residents using population data from the 2015 5-year American Community Survey, adjusting for age, sex, and race. In a secondary analysis, Cox models allowed for the inclusion of vascular risk factors in the assessment of recurrence risk by nSES among those with incident stroke. RESULTS: Of 2,125 patients with incident stroke, 245 had a recurrent stroke during the study period. Poorer nSES was associated with increased stroke recurrence, with rates of 12.5, 17.5, 25.4, and 29.9 per 100,000 in census tracts with ≤5%, >5%-10%, >10%-25%, and >25% below the poverty line, respectively (p < 0.01). The relative risk (95% CI) for recurrent stroke among Black vs White individuals was 2.54 (1.91-3.37) before adjusting for nSES, and 2.00 (1.47-2.74) after adjusting for nSES, a 35.1% decrease. In the secondary analysis, poorer nSES (HR 1.74, 95% CI 1.10-2.76 for lowest vs highest category) and Black race (HR 1.31, 95% CI 1.01-1.70) were both independently associated with recurrence risk, though neither retained significance after full adjustment. Age, diabetes, and left ventricular hypertrophy were associated with increased recurrence risk in fully adjusted models. DISCUSSION: Residents of poorer neighborhoods had a dose-dependent increase in stroke recurrence risk, and neighborhood poverty accounted for approximately one-third of the excess risk among Black individuals. These results highlight the importance of poverty, race, and the intersection of the 2 as potent drivers of stroke recurrence.

Motion preservation for open book injuries of the pubic symphysis -a biomechanical cadaver study.

INTRODUCTION: Open book injuries are challenging injuries that oftentimes require surgical treatment. Currently, treatment is performed with symphyseal plating requiring extensive surgery and entirely limiting physiological movement of the symphyseal joint, frequently resulting in implant failure. Therefore, we investigated the biomechanical properties of a minimally invasive tape suture construct (modified SpeedBridge™) as an alternative stabilization technique for the treatment of open book injuries in human cadaver pelvic rings. MATERIALS AND METHODS: The symphysis of 9 human cadaver pelvises was dissected and dilated to 3 cm creating an open book injury. Next, the two osteosynthesis methods (plating, modified SpeedBridge™) were applied. All specimens then underwent cyclic horizontal and vertical loading, simulating biomechanical forces while sitting, standing and walking. For statistical analysis, 3D dislocation (mm) was calculated. RESULTS: Total displacement (mm) of the pubic symphysis displayed the following means and standard deviations: native group 1.34 ± 0.62 mm, open book group 3.01 ± 1.26 mm, tape group 1.94 ± 0.59 mm and plate group 1.37 ± 0.41 mm. Comparison between native and open book (p = 0.029), open book and plate (p = 0.004), open book and tape (p = 0.031), as well as tape and plate group (p = 0.002) showed significant differences. No significant differences were found when comparing the native and tape (p = 0.059), as well as the native and plate (p = 0.999) group. CONCLUSION: While both osteosynthesis techniques sufficiently stabilized the injury, symphyseal plating displayed the highest rigidity. The modified SpeedBridge™ as a tape suture construct provided statistically sufficient biomechanical stability while maintaining symphyseal micro mobility, consequently allowing ligamental healing of the injured joint without iatrogenic arthrodesis.

Association between sleep-disordered breathing and post-stroke fatigue in patients with ischemic stroke.

OBJECTIVES: Post-stroke fatigue (PSF) is common and often disabling. Sleep-disordered breathing (SDB) is highly prevalent among stroke survivors and can cause fatigue. We explored the relationship between SDB and PSF over time. MATERIALS AND METHODS: Ischemic stroke (IS) patients within the BASIC project were offered SDB screening with a well-validated cardiopulmonary sleep apnea test at 0, 3-, 6-, and 12-months post-stroke. The primary exposure was the respiratory event index (REI; sum of apneas plus hypopneas per hour). The primary outcome was PSF, measured by the SF-36 vitality scale. Associations between REI and PSF were evaluated using linear regression including time-by-REI interactions, allowing the effect of REI to vary over time. RESULTS: Of the 411 IS patients who completed at least one outcome interview, 44 % were female, 61 % Mexican American (MA), 26 % non-Hispanic white, with a mean age of 64 (SD 10). Averaged across timepoints, REI was not associated with PSF. In a time-varying model, higher REI was associated with greater PSF at 3-months (ß = 1.75, CI = 0.08, 3.43), but not at 6- or 12-months. Across timepoints, female sex, depressive symptoms, and comorbidity burden were associated with greater PSF, whereas MA ethnicity was associated with less PSF. CONCLUSIONS: Higher REI was associated with modestly greater PSF in the early post-stroke period, but no association was observed at 6 months and beyond. SDB may be a modest modifiable risk factor for early PSF, but its treatment is unlikely to have a substantial impact on long-term PSF. MA ethnicity seems to be protective against PSF.

Long-Term Psychological Distress Among Surrogate Decision Makers for Mexican American and Non-Hispanic White Patients With Severe Stroke.

BACKGROUND AND OBJECTIVES: During acute hospitalizations, physicians often focus on the stroke patient and not family who may be traumatized by this sudden change to their loved one. We investigated long-term psychological distress among family surrogate decision makers for Mexican American (MA) and non-Hispanic White (NHW) severe stroke patients. Previous work in other diseases suggested worse psychological outcomes in MA than NHW caregivers. METHODS: This was a population-based, prospective cohort study in Nueces County, TX. Stroke patient participants and their surrogate decision makers were enrolled soon after any stroke between April, 2016, and October, 2020, if surrogates had made decisions about life-sustaining treatments. Surrogates completed validated measures of posttraumatic stress, National Stressful Events Survey for Posttraumatic Stress Disorder Short Scale; anxiety, Generalized Anxiety Disorder-7; and depression, Patient Health Questionnaire-8 at discharge, 3, 6, and 12 months. Ethnic differences were assessed with multilevel linear mixed models, sequentially adjusted for prespecified patient and surrogate demographic, socioeconomic, and clinical covariates. RESULTS: There were 301 family surrogates for 241 severe stroke patients. The mean follow-up was 315 days. High scores on measures of psychological distress ranged between 17% and 28% of surrogates. One or more high levels of the psychological outcomes were found in 17%-43% of surrogates; 2 or more were found in 12%-27%; and all 3 were found in 5%-16% of surrogates. All psychological outcomes were worse among MAs on unadjusted analyses. In fully adjusted models, posttraumatic stress remained worse among MAs (0.36, 95% CI 0.17-0.56); ethnic differences were attenuated and no longer significant in the final model for anxiety (0.59, 95% CI -0.55 to 1.74) and depression (0.97, 95% CI -0.25 to 2.19). The trajectory for depression did differ by ethnicity (interaction p = 0.03), with depression score improving more rapidly over time among NHWs than MAs. Advance care plans did not seem to confound any ethnic differences. DISCUSSION: Psychological distress is common among family surrogate decision makers in the year after stroke and may be worse among MAs. Efforts are needed to support family members of all ethnic groups after severe stroke.

Uncemented hip revision cup as an alternative for T-type acetabular fractures: A cadaveric study.

BACKGROUND: The current rise in elderly patients with compromised bone quality complicates the surgical treatment of acetabular T-type fractures (AO type 62B2 fractures). There is on ongoing discussion about the treatment options, mostly consisting of an open reduction and internal fixation (ORIF) with or without primary or secondary total hip arthroplasty (THA). Yet, these patients are oftentimes unable to fulfil weight-bearing restrictions and mostly present with an unavailability of a stable anchor site. Consequently, this study investigates the feasibility of a cementless hip revision cup for acetabular T-type fractures and compares its biomechanical properties to ORIF. HYPOTHESIS: The cementless hip revision cup provides sufficient biomechanical stability under the simulation of full weight-bearing. PATIENTS AND METHODS: The study compared two groups of human cadaveric hip bones with T-type fractures, of whom 6 subjects were treated with ORIF (6 male; mean age: 62±17years; mean body weight: 75±15) versus 6 subjects treated with a cementless hip revision cup (2 male; 69±12 years; 73±15kg). The group-assignment was controlled for comparable BMD results (mean BMD: ORIF 110±37 mg Ca-Ha/mL versus hip revision cup 134±32 mg Ca-Ha/mL). To compare for biomechanical stability cyclic loading was applied measuring the force and dislocation of the fracture gap at standardized bone loci using an all-electric testing machine and a 3D-ultrasound measuring system. RESULTS: Comparing superior pubic ramus versus iliac wing (cementless hip revision cup versus ORIF [mean±standard deviation]: 5.8±2.0 versus 7.0±3.2; p=0.032) as well as sacral ala versus iliac wing (4.6±2.2 versus 6.4±3.7; p=0.002), the cementless revision cup achieved a significantly higher stability than the plate osteosynthesis. CONCLUSION: Revision cup and ORIF withstood biomechanical loading forces exceeding full weight-bearing in this biomechanical study. The results of our study suggest that the cementless hip revision cup might be promising alternative to the current standard care of ORIF with or without primary THA. LEVEL OF EVIDENCE: III; case control experimental study.

Micro-Structural and Biomechanical Evaluation of Bioresorbable and Conventional Bone Cements for Augmentation of the Proximal Femoral Nail.

Osteoporotic proximal femur fractures are on the rise due to demographic change. The most dominant surgical treatment option for per/subtrochanteric fractures is cephalomedullary nailing. As it has been shown to increase primary stability, cement augmentation has become increasingly popular in the treatment of osteoporotic per/subtrochanteric femur fractures. The ultimate goal is to achieve stable osteosynthesis, allowing for rapid full weight-bearing to reduce possible postoperative complications. In recent years, bioresorbable bone cements have been developed and are now mainly used to fill bone voids. The aim of this study was to evaluate the biomechanical stability as well as the micro-structural behaviour of bioresorbable bone cements compared to conventional polymethylmethacrylate (PMMA)-cements in a subtrochanteric femur fracture model. Biomechanical as well as micro-computed tomography morphology analysis revealed no significant differences in both bone cements, as they showed equal mechanical stability and tight interdigitation into the spongious bone of the femoral head. Given the positive risk/benefit ratio for bioresorbable bone cements, their utilisation should be evaluated in future clinical studies, making them a promising alternative to PMMA-bone cements.

Evaluation of a New Treatment Strategy for Geriatric Fragility Fractures of the Posterior Pelvic Ring Using Sensor-Supported Insoles: A Proof-of-Concept Study.

The incidence of fragility fractures of the pelvis (FFPs) is currently rising. Surgical treatment, which is performed using sacroiliac screws, is complicated by compromised bone quality, oftentimes resulting in implant failure. The iFuse implant system aims to improve attachment and durability with promising results for sacroiliac dysfunction, though data for its feasibility on FFPs are rare. Consequently, this study aims to evaluate the feasibility of the iFuse for FFPs. A total of 10 patients with FFPs were treated with the iFuse in this study. Pre- and postoperatively, both mobility using an established insole force sensor for an inpatient gait analysis and general well-being and pain using questionnaires were evaluated. When comparing pre- and postoperative findings, this study demonstrated a significant increase in the average (8.14%) and maximum (9.4%) loading (p < 0.001), a reduction in pain, as measured by the visual analog scale (VAS), from 4.60 to 2.80 at rest (p = 0.011) and from 7.00 to 4.40 during movement (p = 0.008), an increase in the Barthel Index by 20 points (p < 0.001) and an increase in the Parker Mobility Score by 2.00 points (p = 0.011). All this contributes to the possibility of early postoperative mobilization and improved general well-being, ultimately preventing the late consequences of postoperative immobilization and maintaining patients autonomy and contentment.

Novel Tape Suture Osteosynthesis for Hyperextension Injuries of the Subaxial Cervical Spine: A Biomechanical Study.

BACKGROUND/AIM: Anterior tension band injuries are usually the result of high impact hyperextension trauma. Current surgical treatment includes anterior cervical discectomy and fusion bearing the risk of soft tissue irritation, degeneration of adjacent cervical segments, implant failure or iatrogenic spondylodesis. This study examined the biomechanical properties of tape suture constructs reenforcing ligamental stability for the treatment of Association of Osteosynthesis (AO) type B3 injuries compared to anterior fusion. MATERIALS AND METHODS: After creation of an AO type B3 injury in synthetic cervical segments (C5/6, Sawbone®), seven segments were treated with anterior fusion and seven with a tape suture construct, similar to the SpeedBridge™ (Arthrex®). Biomechanical testing was performed, simulating extension, flexion, lateral bending, and rotation. Dislocation (°) and corresponding force (N) were measured and compared. RESULTS: Anterior fusion displayed a mean range of extension, lateral bending, and rotation of 3.60° (SD 1.87°), 2.28° (SD 1.55°), and 2.81° (SD 0.78°), respectively. The tape suture showed a mean range of extension, lateral bending, and rotation of 4.24° (SD 0.81°) (p=0.146), 5.44° (SD 1.56°) (p=0.013), and 5.29° (SD 1.44°) (p<0.01), respectively. No specimen suffered from implant failure. CONCLUSION: The tape suture construct provides sufficient biomechanical stability for the treatment of AO type B3 injuries compared to anterior fusion. Regarding cervical extension, whose limitation is crucial for ligamental healing, the tape suture shows no significant inferiority. Yet, the tape suture approaches physiological mobility in the planes not affected by the injury. Consequently, the tape suture is a promising alternative preventing an iatrogenic spondylodesis.

Tape suture constructs for instabilities of the pubic symphysis: is the idea of motion preservation a suitable treatment option? A cadaver study.

INTRODUCTION: Current gold standard for the treatment of symphyseal disruptions includes anterior plating, almost entirely prohibiting symphyseal mobility and resulting in an iatrogenic arthrodesis followed by high rates of implant failure. Minimally invasive tape suture constructs have been found to maintain the micro mobility of ligamentous injuries, yet still providing sufficient biomechanical stability. Recently, this technique has been primarily investigated for symphyseal disruptions on synthetic pelvic models. Therefore, the aim of this study was to examine the feasibility of this novel flexible osteosynthesis on cadaveric pelvic models based on the following hypothesis: tape suture constructs ensure sufficient biomechanical stability without inhibiting micro mobility of the pubic symphysis for the treatment of symphyseal disruptions and maintain stability during long-term loading. MATERIALS AND METHODS: 9 cadaveric anterior pelvic rings were used in this study and a symphyseal disruption was created in every specimen. The specimens were then exposed to short- and long-term vertical and horizontal cyclic loading after treatment with a tape suture construct in criss-cross technique. The mean maximum displacement (mm) during cyclic loading and the corresponding stiffness (N/mm) were measured and compared. RESULTS: Regarding both displacement (mm) and corresponding stiffness (N/mm), the tape sutures displayed a significant difference between short- and long-term loading for cranial and caudal vertical loading (p < 0.01) but differences remained non-significant for horizontal loading (p > 0.05). No tape suture suffered from implant failure during long-term loading. CONCLUSIONS: The tape suture construct displayed sufficient biomechanical stability without exceeding the physiological mobility of 2 mm of the pubic symphysis; however, also maintained the desired micro mobility of the affected joint necessary to prevent an iatrogenic arthrodesis. Further, all tape sutures maintained stability throughout long-term loading.

Improving stability of atlantoaxial fusion: a biomechanical study.

PURPOSE: The incidence of atlanto-axial injuries is continuously increasing and often requires surgical treatment. Recently, Harati developed a new procedure combining polyaxial transarticular screws with polyaxial atlas massae lateralis screws via a rod system with promising clinical results, yet biomechanical data is lacking. This biomechanical study consequently aims to evaluate the properties of the Harati technique. METHODS: Two groups, each consisting of 7 cervical vertebral segments (C1/2), were formed and provided with a dens axis type 2 fracture according to Alonzo. One group was treated with the Harms and the other with the Harati technique. The specimen was loaded via a lever arm to simulate extension, flexion, lateral flexion and rotation. For statistical analysis, dislocation (°) was measured and compared. RESULTS: For extension and flexion, the Harati technique displayed a mean dislocation of 4.12° ± 2.36° and the Harms technique of 8.48° ± 1.49° (p < 0.01). For lateral flexion, the dislocation was 0.57° ± 0.30° for the Harati and 1.19° ± 0.25° for the Harms group (p < 0.01). The mean dislocation for rotation was 1.09° ± 0.48° for the Harati and 2.10° ± 0.31° for the Harms group (p < 0.01). No implant failure occurred. CONCLUSION: This study found a significant increase in biomechanical stability of the Harati technique when compared to the technique by Harms et al. Consequently, this novel technique can be regarded as a promising alternative for the treatment of atlanto-axial instabilities.

In vivo immunomodulation of IL6 signaling in a murine multiple trauma model.

A significant number of trauma patients die during the ICU phase of care because of a severe immune response. Interleukin-6 (IL6) plays a central role within that immune response, signaling through a membrane-bound (IL6-R) and a soluble IL6 receptor (sIL6-R). IL6 and the sIL6-R can form an agonistic IL6/sIL6-R-complex, activating numerous cells that are usually not IL6 responsive, a process called trans-signaling. We attempted to demonstrate that modulation of the IL6 signaling (classic signaling and trans-signaling) can attenuate the devastating immune response after trauma in a murine multiple trauma model. Mice were allocated to three study arms: sham, fracture or polytrauma. Half of the animals had the application of an IL6-R antibody following an intervention. After a pre-set time, blood samples were analysed for IL6 and sIL6-R serum levels, organs were analysed for neutrophil infiltration and end organ damage was evaluated. IL6 and sIL6-R showed a rapid peak after fracture, and much more markedly after polytrauma. These parameters were reduced significantly by globally blocking IL6 signaling via IL6-R antibody (Mab) application. Shock organ analysis also illustrated significant neutrophil infiltration following polytrauma, which was also abated via IL6-R Mab application. Furthermore, end organ damage was reduced by IL6-R Mab application. The study results prove the regulatory role of IL6 signaling pathways in polytrauma, with haemorrhagic shock being a major trigger of inflammatory response. Modulation of IL6 signaling shows promise in the prevention of adverse events like organ failure following major trauma and might be a target for in vivo immunomodulation to reduce mortality in severely injured patients, but further evaluation regarding classic IL6 signaling and IL6 trans-signaling is needed.

Differential Impact of Stroke on Cognitive Impairment in Mexican Americans and Non-Hispanic White Americans.

BACKGROUND: The association between stroke and dementia is well established. Less is known about this association in underrepresented ethnic groups. In a large ethnically diverse cohort, we examined whether history of stroke was associated with cognitive impairment, and whether this relationship differed by ethnicity (Mexican American [MA] versus non-Hispanic White). METHODS: This was a population-based cohort study conducted in Nueces County, TX, a biethnic community with a large and primarily nonimmigrant MA population. Residents aged ≥65 were recruited door-to-door or by telephone between May 2018 and December 2021. The primary exposure was history of stroke, obtained by self-report. Demographic, medical, and educational histories were also obtained. The primary outcome was the Montreal Cognitive Assessment (MoCA), a scale that evaluates multiple domains of cognitive performance. Scores were divided into 3 ordinal categories, roughly corresponding to normal cognition (MoCA 26-30), mild cognitive impairment (MoCA 20-25), or probable dementia (MoCA 0-19). RESULTS: One thousand eight hundred one participants completed MoCA screening (55% female; 50% MA, 44% Non-Hispanic White, 6% other), of whom 12.4% reported history of stroke. Stroke prevalence was similar across ethnicities (X2 2.1; P=0.34). In a multivariable cumulative logit regression model for the ordinal cognition outcome, a stroke by ethnicity interaction was observed (P=0.01). Models stratified by ethnicity revealed that stroke was associated with cognitive impairment across ethnicities, but had greater impact on cognition in non-Hispanic Whites (cumulative odds ratio=3.81 [95% CI, 2.37-6.12]) than in MAs (cumulative odds ratio=1.58 [95% CI, 1.04-2.41]). Increased age and lower educational attainment were also associated with cognitive impairment, regardless of ethnicity. CONCLUSIONS: History of stroke was associated with increased odds of cognitive impairment after controlling for other factors in both MA and Non-Hispanic White participants. The magnitude of the impact of stroke on cognition was less in MA than in Non-Hispanic White participants.

Ethical Considerations during the Informed Consent Process for Acute Ischemic Stroke in International Clinical Trials.

We sought to investigate the experiences of researchers in existing active-control trials in acute ischemic stroke comparing investigational therapy to tissue plasminogen activator (tPA) in order to identify the approaches and challenges in obtaining informed consent. Out of 401 articles evaluated, 14 trials met inclusion criteria. Trial representatives were contacted to complete a survey concerning the consent process. None of the 14 trials published materials related to the informed consent process. Trials with 75% to 100% of patients directly consented had shorter door-to-treatment (DTT) times than trials that directly consented less than 50% of patients. Trials that had translators available (for recruiting participants who were not native speakers in the local language) and translated consent documents had longer DTT times. The study findings suggest that differences in the standards of informed consent internationally may allow more patients with moderate strokes to provide direct consent without delaying DTT time. Future trials should emphasize transparency to the public and scientific community in the informed consent process.

Does augmentation increase the pull-out force of symphyseal screws? A biomechanical cadaver study.

PURPOSE: Open reduction and internal fixation using anterior plate osteosynthesis currently represents the gold standard for the treatment of symphyseal disruptions. Since postoperative screw loosening with consequent implant failure is frequently observed, this study aims to evaluate if and to what extent augmentation can increase the pull-out force of symphyseal screws to improve the constructs stability. METHODS: Twelve human cadaveric anterior pelvic rings were separated at the symphyseal joint for bilateral testing, consequently achieving comparable sites. First, one non-augmented screw was drilled into the superior pubic ramus, whereas the contralateral side was primarily augmented. The screws were then withdrawn with a constant speed of 10 mm/min and the fixation strengths determined by the force (N) displacement (mm) curve. Finally, the primary non-augmented site was secondary augmented, representing revision surgery after initial implant failure, and the corresponding fixation strength was measured again. RESULTS: Augmentation compared to non-augmented screws displayed significantly higher pull-out forces with an increase in pull-out force by 377% for primary and 353% for secondary augmentation (p < 0.01). There was no significant difference in the pull-out force comparing primary and secondary augmentation (p = 0.74). CONCLUSIONS: Primary and secondary augmentation significantly increases the stability of symphyseal screws and, therefore, potentially decreases rates of implant failure.

A Novel Device for Closed Reduction and Percutaneous Fixation of Thoracolumbar Fractures.

BACKGROUND/AIM: Open surgical reduction/fixation of thoracolumbar fractures results in significant soft-tissue trauma and related complications. Minimally-invasive technical developments could deliver similar radiological outcomes, while avoiding the related complications. We evaluated radiological and perioperative outcomes in thoracolumbar fractures by using a novel minimally-invasive device. PATIENTS AND METHODS: Twenty-six patients with 29 thoracolumbar fractures using the NForce device were analyzed. Postoperative reduction and alignment were assessed by radiographic measurement of the local kyphosis angle (LKA) up until a follow-up period of 9 months. RESULTS: Postoperative imaging revealed an average reduction of traumatic kyphosis of 8.25° (±7.72°) with an average postoperative LKA of 3.24° (±8.97°). The highest degree of reduction was 27.39°. The mean LKA had increased to 5.08° (±5.17°) at 3 months postoperative, 5.43° (±4.32°) at 6 months and 6.21° (±3.82°) at 9 months. CONCLUSION: The minimally invasive NForce system is effective in performing anatomic percutaneous reduction/fixation.

Novel minimally invasive tape suture osteosynthesis for instabilities of the pubic symphysis: a biomechanical study.

INTRODUCTION: Open book fractures are challenging injuries oftentimes requiring surgical treatment. The current treatment of choice is symphyseal plating, which requires extensive surgery and entirely limits physiological movement of the symphyseal joint, frequently resulting in implant failure. Therefore, we investigated the biomechanical properties of a semi-rigid implant (modified SpeedBridge™) as a minimally invasive tape suture construct for the treatment of open book fractures and evaluated the superiority of two techniques of implementation: criss-cross vs. triangle technique. MATERIALS AND METHODS: Nine synthetic symphyseal joints were dissected creating an open book fracture. The different osteosynthesis methods (plating, modified SpeedBridge™ in criss-cross/triangle technique) were then applied. All constructs underwent horizontal and vertical loading, simulating biomechanical forces while sitting, standing and walking. For statistical analysis, dislocation (mm) and stiffness (N/mm) were calculated. RESULTS: Symphyseal plating for the treatment of open book fractures proved to be a rigid osteosynthesis significantly limiting the physiological mobility of the symphyseal joint (dislocation: 0.08 ± 0.01 mm) compared to the tape sutures (dislocation: triangle technique 0.27 ± 0.07 mm, criss-cross technique 0.23 ± 0.05 mm) regarding horizontal tension (p < 0.01). Both modified SpeedBridge™ techniques showed sufficient biomechanical stability without one being superior to the other (p > 0.05 in all directions). Considering vertical loading, no statistical difference was found between all osteosynthesis methods (caudal: p = 0.41; cranial: p = 0.61). CONCLUSIONS: Symphyseal plating proved to be the osteosynthesis method with the highest rigidity. The modified SpeedBridge™ as a semi-rigid suture construct provided statistically sufficient biomechanical stability while maintaining a minimum of symphyseal movement, consequently allowing ligamental healing of the injured joint without iatrogenic arthrodesis. Furthermore, both the criss-cross and the triangle technique displayed significant biomechanical stability without one method being superior.