In Vitro Testing and Clinical Handling of a Novel Implant Positioning Technology for Proximal Humeral Plating.

BACKGROUND AND OBJECTIVES: Fractures of the proximal humerus are common, particularly in elderly populations. Anatomical locking plates target stabilization with a multitude of screws spanning into the humeral head. Sound implant placement and screw length determination are key for a successful clinical outcome but are difficult to obtain from planar X-rays. A novel implant positioning technology for proximal humerus plating (Xin1) outputs screw lengths suggestions and plate position based on hole projections in conventional X-ray images. This study investigated the performance of a prototype Xin1 system in a postmortem (in vitro) experiment as well as in a clinical handling test. MATERIALS AND METHODS: For in vitro testing, twelve shoulders from six anatomical specimens were randomized into two groups to compare the Xin1 technique to the conventional operation in terms of surgical precision, procedure time and X-ray exposure. For the clinical trial, 11 patients undergoing plating of the proximal humerus were included. The aim was to investigate clinical handling of the Xin1 marker clip and to retrospectively evaluate the system performance in a real-life fracture situation. Image pairs before and after insertion of the proximal screws were retrospectively processed to investigate the influence of potential bone fragment shifts on the system output. RESULTS: In the postmortem experiment, the use of the system significantly improved the surgical precision (52% error reduction), procedure time (38% shorter) and radiation exposure (64% less X-rays). Clinical handling demonstrated seamless embedding of the marker clip into existing clinical workflows without adverse events reported. Retrospective X-ray analysis on six eligible patients revealed differences in the calculated screw lengths of ≤2 mm before and after screw insertion for five patients. In one patient, the screw lengths differed up to 8 mm, which might indicate displacement of the head fragment. CONCLUSIONS: Results suggest a strong potential of the Xin1 assistance technology to enhance the surgical procedure and patient outcomes in the rising incidence of osteoporotic humeral fractures. Robust performance in a real-life fracture situation was observed. In-depth validation of the system is, however, needed before placing it into clinical practice.

Prevalence of healthy aging among community dwelling adults age 70 and older from five European countries.

BACKGROUND: To compare the prevalence of healthy aging among adults age 70 and older from 5 European countries recruited for the DO-HEALTH clinical trial. Participants were selected for absence of prior major health events. METHODS: Cross-sectional analysis of DO-HEALTH baseline data. All 2,157 participants (mean age 74.9, SD 4.4; 61.7% women) were included and 2,123 had data for all domains of the healthy aging status (HA) definition. HA was assessed based on the Nurses` Health Study (NHS) definition requiring four domains: no major chronic diseases, no disabilities, no cognitive impairment (Montreal Cognitive Assessment, MoCA ≥25), no mental health limitation (GDS-5 <2, and no diagnosis of depression). Association between HA and age, BMI, gender, and physical function (sit-to-stand, gait speed, grip strength) was assessed by multivariate logistic regression analyses adjusting for center. RESULTS: Overall, 41.8% of DO-HEALTH participants were healthy agers with significant variability by country: Austria (Innsbruck) 58.3%, Switzerland (Zurich, Basel, Geneva) 51.2%, Germany (Berlin) 37.6%, France (Toulouse) 36.7% and Portugal (Coimbra) 8.8% (p <0.0001). Differences in prevalence by country persisted after adjustment for age. In the multivariate model, younger age (OR = 0.95, 95% CI 0.93 to 0.98), female gender (OR = 1.36, 95% CI 1.03 to 1.81), lower BMI (OR = 0.94, 95% CI 0.91 to 0.96), faster gait speed (OR = 4.70, 95% CI 2.68 to 8.25) and faster performance in sit-to-stand test (OR = 0.90, 95% CI 0.87 to 0.93) were independently and significantly associated with HA. CONCLUSIONS: Despite the same inclusion and exclusion criteria preselecting relatively healthy adults age 70 years and older, HA prevalence in DO-HEALTH varied significantly between countries and was highest in participants from Austria and Switzerland, lowest in participants from Portugal. Independent of country, younger age, female gender, lower BMI and better physical function were associated with HA. TRIAL REGISTRATION: DO-HEALTH was registered under the protocol NCT01745263 at the International Trials Registry ( clinicaltrials.gov ), and under the protocol number 2012-001249-41 at the Registration at the European Community Clinical Trial System (EudraCT).

Simplified Mechanical Tests Can Simulate Physiological Mechanics of a Fixation Construct for Periprosthetic Femoral Fractures.

Plate fractures after fixation of a Vancouver Type B1 periprosthetic femoral fracture (PFF) are difficult to treat and could lead to severe disability. However, due to the lack of direct measurement of in vivo performance of the PFF fixation construct, it is unknown whether current standard mechanical tests or previous experimental and computational studies have appropriately reproduced the in vivo mechanics of the plate. To provide a basis for the evaluation and development of appropriate mechanical tests for assessment of plate fracture risk, this study applied loads of common activities of daily living (ADLs) to implanted femur finite element (FE) models with PFF fixation constructs with an existing or a healed PFF. Based on FE simulated plate mechanics, the standard four-point-bend test adequately matched the stress state and the resultant bending moment in the plate as compared with femur models with an existing PFF. In addition, the newly developed constrained three-point-bend tests were able to reproduce plate stresses in models with a healed PFF. Furthermore, a combined bending and compression cadaveric test was appropriate for risk assessment including both plate fracture and screw loosening after the complete healing of PFF. The result of this study provides the means for combined experimental and computational preclinical evaluation of PFF fixation constructs.

Validation of the revised 2018 AAST-OIS classification and the CT severity index for prediction of operative management and survival in patients with blunt spleen and liver injuries.

OBJECTIVES: Non-operative management (NOM) is increasingly utilised in blunt abdominal trauma. The 1994 American Association of Surgery of Trauma grading (1994-AAST) is applied for clinical decision-making in many institutions. Recently, classifications incorporating contrast extravasation such as the CT severity index (CTSI) and 2018 update of the liver and spleen AAST were proposed to predict outcome and guide treatment, but validation is pending. METHODS: CT images of patients admitted 2000-2016 with blunt splenic and hepatic injury were systematically re-evaluated for 1994/2018-AAST and CTSI grading. Diagnostic accuracy, diagnostic odds ratio (DOR), and positive and negative predictive values were calculated for prediction of in-hospital mortality. Correlation with treatment strategy was assessed by Cramer V statistics. RESULTS: Seven hundred and three patients were analysed, 271 with splenic, 352 with hepatic and 80 with hepatosplenic injury. Primary NOM was applied in 83% of patients; mortality was 4.8%. Comparing prediction of mortality in mild and severe splenic injuries, the CTSI (3.1% vs. 10.3%; diagnostic accuracy = 75.4%; DOR = 3.66; p = 0.006) and 1994-AAST (3.3% vs. 10.5%; diagnostic accuracy = 77.9%; DOR = 3.45; p = 0.010) were more accurate compared with the 2018-AAST (3.4% vs. 8%; diagnostic accuracy = 68.2%; DOR = 2.50; p = 0.059). In hepatic injuries, the CTSI was superior to both AAST classifications in terms of diagnostic accuracy (88.7% vs. 77.1% and 77.3%, respectively). CTSI and 2018-AAST correlated better with the need for surgery in severe vs. mild hepatic (Cramer V = 0.464 and 0.498) and splenic injuries (Cramer V = 0.273 and 0.293) compared with 1994-AAST (Cramer V = 0.389 and 0.255; all p < 0.001). CONCLUSIONS: The 2018-AAST and CTSI are superior to the 1994-AAST in correlation with operative treatment in splenic and hepatic trauma. The CTSI outperforms the 2018-AAST in mortality prediction. KEY POINTS: • Non-operative management of blunt abdominal trauma is increasingly applied and correct patient stratification is crucial. • CT-based scoring systems are used to assess injury severity and guide clinical decision-making, whereby the 1994 version of the American Association of Surgery of Trauma Organ Injury Scale (AAST-OIS) is currently most commonly utilised. • Including contrast media extravasation in CT-based grading improves management and outcome prediction. While the 2018-AAST classification and the CT-severity-index (CTSI) better correlate with need for surgery compared to the 1994-AAST, the CTSI is superior in outcome-prediction to the 2018-AAST.

Effect of Vitamin D Supplementation, Omega-3 Fatty Acid Supplementation, or a Strength-Training Exercise Program on Clinical Outcomes in Older Adults: The DO-HEALTH Randomized Clinical Trial.

Importance: The benefits of vitamin D, omega-3 fatty acids, and exercise in disease prevention remain unclear. Objective: To test whether vitamin D, omega-3s, and a strength-training exercise program, alone or in combination, improved 6 health outcomes among older adults. Design, Setting, and Participants: Double-blind, placebo-controlled, 2 × 2 × 2 factorial randomized clinical trial among 2157 adults aged 70 years or older who had no major health events in the 5 years prior to enrollment and had sufficient mobility and good cognitive status. Patients were recruited between December 2012 and November 2014, and final follow-up was in November 2017. Interventions: Participants were randomized to 3 years of intervention in 1 of the following 8 groups: 2000 IU/d of vitamin D3, 1 g/d of omega-3s, and a strength-training exercise program (n = 264); vitamin D3 and omega-3s (n = 265); vitamin D3 and exercise (n = 275); vitamin D3 alone (n = 272); omega-3s and exercise (n = 275); omega-3s alone (n = 269); exercise alone (n = 267); or placebo (n = 270). Main Outcomes and Measures: The 6 primary outcomes were change in systolic and diastolic blood pressure (BP), Short Physical Performance Battery (SPPB), Montreal Cognitive Assessment (MoCA), and incidence rates (IRs) of nonvertebral fractures and infections over 3 years. Based on multiple comparisons of 6 primary end points, 99% confidence intervals are presented and P < .01 was required for statistical significance. Results: Among 2157 randomized participants (mean age, 74.9 years; 61.7% women), 1900 (88%) completed the study. Median follow-up was 2.99 years. Overall, there were no statistically significant benefits of any intervention individually or in combination for the 6 end points at 3 years. For instance, the differences in mean change in systolic BP with vitamin D vs no vitamin D and with omega-3s vs no omega-3s were both -0.8 (99% CI, -2.1 to 0.5) mm Hg, with P < .13 and P < .11, respectively; the difference in mean change in diastolic BP with omega-3s vs no omega-3s was -0.5 (99% CI, -1.2 to 0.2) mm Hg; P = .06); and the difference in mean change in IR of infections with omega-3s vs no omega-3s was -0.13 (99% CI, -0.23 to -0.03), with an IR ratio of 0.89 (99% CI, 0.78-1.01; P = .02). No effects were found on the outcomes of SPPB, MoCA, and incidence of nonvertebral fractures). A total of 25 deaths were reported, with similar numbers in all treatment groups. Conclusions and Relevance: Among adults without major comorbidities aged 70 years or older, treatment with vitamin D3, omega-3s, or a strength-training exercise program did not result in statistically significant differences in improvement in systolic or diastolic blood pressure, nonvertebral fractures, physical performance, infection rates, or cognitive function. These findings do not support the effectiveness of these 3 interventions for these clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT01745263.

Fracture fixation versus revision arthroplasty in Vancouver type B2 and B3 periprosthetic femoral fractures: a systematic review.

INTRODUCTION: Hip arthroplasty (HA) is commonly performed to treat various hip pathologies. Its volume is expected to rise further due to the increasing age of the population. Complication rates are low; however, periprosthetic femoral fractures (PFF) are a rare, albeit serious, complication with substantial economic impact. While current guidelines propose revision with long-stemmed prostheses for all Vancouver B2 and B3 PFF, some recent research papers suggest that open reduction with internal fixation (ORIF) could lead to an equivalent outcome. Our aim was to summarize the evidence, elucidating under which circumstances ORIF leads to a favorable outcome after B2 and B3 PFF compared with revision surgery. MATERIALS AND METHODS: A systematic literature search was performed to identify studies on patients treated with ORIF and with stem revision after B2 and/or B3 fractures. Extracted information included initial pathology, stem fixation mechanism, bone quality and stem stability at the time of PFF, clinical outcomes, and mortality. Results of individual studies were summarized in a table in lieu of a quantitative data synthesis due to a lack of standardized information. RESULTS: We identified 14 original research articles including both patients treated with ORIF and with stem revision after B2 and/or B3 PFF. Five studies included statistical comparisons, all were in favor of ORIF or indeterminate. The common lack of rigorous statistical analyses and significant methodological weaknesses made identification of outcome predictors impossible. CONCLUSION: The choice of treatment modality for PFF depends on fracture, implant, and bone characteristics. Recent data show that successful outcome can be achieved without revising loose stems. ORIF may be a viable option if bone stock is adequate around uncemented or tapered polished stems with an intact cement mantle and the fracture geometry allows stable anatomic reconstruction. Conceptional considerations support this idea, but more data are needed to identify outcome predictors.

Screw tip augmentation leads to improved primary stability in the minimally invasive treatment of displaced intra-articular fractures of the calcaneus: a biomechanical study.

PURPOSE: To investigate if the stability of minimally invasive screw osteosynthesis of displaced intra-articular calcaneal fractures (DIACF) can be effectively increased by an innovative approach to screw tip augmentation. METHODS: In eight-paired human cadaver hindfoot specimens, DIACF of Sanders type IIB were treated with either standard screw osteosynthesis or with bone cement augmentation of the screw tips in the main fragments. The instrumented specimens were subjected to a cyclic loading protocol (9000 cycles, with stepwise increasing loads, 100-1000 N). The interfragment motions were quantified as tuber fragment tilt (TFT) and posterior facet inclination angle (PFIA) using a 3-D motion analysis system. Böhler's angle (BA) was evaluated from X-rays. A load-to-failure test was performed after the cyclic loading protocol. RESULTS: All but one specimen of the augmented group withstood more cycles than the respective specimens of the non-augmented group. Mean cycles to failure for the failure criterion of 5° TFT were 7299 ± 1876 vs. 3864 ± 1810, corresponding to loads of 811 N ± 195 vs. 481 N ± 180, (P = 0.043). There were no significant differences observed in the PFIAs. The failure criterion of 5° BA was reached after a mean of 7929 cycles ± 2004 in the augmented group and 4129 cycles ± 2178 in the non-augmented group, corresponding to loads of 893 N ± 200 vs. 513 N ± 218, (P = 0,090). The mean load-to-failure of the four specimens in the augmented group that completed the cyclic loading was 1969 N over a 1742-2483 N range. CONCLUSION: Screw tip augmentation significantly improved the mechanical stability of the calcanei after osteosynthesis in terms of decreased tuber fragment tilts and less changes in Böhler's angle.

Correction to: A simple approach for the preoperative assessment of sacral morphology for percutaneous SI screw fixation.

In the original article, co-author's given name has been published incorrectly. The correct given name should be Vinzent Kevin.

Subchondral screw abutment: does it harm the joint cartilage? An in vivo study on sheep tibiae.

PURPOSE: Subchondral screw abutment in osteosynthesis of joint fractures is an effective method to achieve sufficient screw grip. In this study we investigated if subchondral screw placement is possible without harming the overlying subchondral plate and joint cartilage iatrogenic. MATERIALS AND METHODS: A 3.5-mm conventional steel screw was placed in the tibia of ten sheep in distances between 1 and 7 mm beneath the joint cartilage. After a follow up of two and four months, evaluation of the subchondral bone and joint cartilage was performed by means of a histological osteoarthritis score, HRpQCT imaging and determination of the glycosaminoglycan content in the cartilage. The control group was the contralateral knee of the same animal. RESULTS: Histomorphometric evaluation of the Mankin osteoarthritis score revealed no significant difference compared to the control after two (p = 0.102) and four months (p = 0.429). No correlation between distance of the screw to the cartilage and histological scoring was found (p = 0.658, R2 = 0.04 after two months and p = 0.171, R2 = 0.18 after four months). HRpQCT measurements of the subchondral thickness between screw and cartilage after two (p = 0.05) and four months (p = 0.424) showed no significant difference. Mean glycosaminoglycan content in the treatment group compared to the control after two months (p = 0.25) and four months (p = 0.523) was not significant different. CONCLUSION: In conclusion subchondral screw abutment did not damage the joint cartilage after a two- and four-month follow up in this sheep model.

Fast-resorbable antibiotic-loaded hydrogel coating to reduce post-surgical infection after internal osteosynthesis: a multicenter randomized controlled trial.

BACKGROUND: Infection is one of the main reasons for failure of orthopedic implants. Antibacterial coatings may prevent bacterial adhesion and biofilm formation, according to various preclinical studies. The aim of the present study is to report the first clinical trial on an antibiotic-loaded fast-resorbable hydrogel coating (Defensive Antibacterial Coating, DAC®) to prevent surgical site infection, in patients undergoing internal osteosynthesis for closed fractures. MATERIALS AND METHODS: In this multicenter randomized controlled prospective study, a total of 256 patients in five European orthopedic centers who were scheduled to receive osteosynthesis for a closed fracture, were randomly assigned to receive antibiotic-loaded DAC or to a control group (without coating). Pre- and postoperative assessment of laboratory tests, wound healing, clinical scores and X-rays were performed at fixed time intervals. RESULTS: Overall, 253 patients were available with a mean follow-up of 18.1 ± 4.5 months (range 12-30). On average, wound healing, clinical scores, laboratory tests and radiographic findings did not show any significant difference between the two groups. Six surgical site infections (4.6%) were observed in the control group compared to none in the treated group (P < 0.03). No local or systemic side-effects related to the DAC hydrogel product were observed and no detectable interference with bone healing was noted. CONCLUSIONS: The use of a fast-resorbable antibiotic-loaded hydrogel implant coating provides a reduced rate of post-surgical site infections after internal osteosynthesis for closed fractures, without any detectable adverse event or side-effects. LEVEL OF EVIDENCE: 2.

Bone Mass Distribution of the Distal Tibia in Normal, Osteopenic, and Osteoporotic Conditions: An Ex Vivo Assessment Using HR-pQCT, DXA, and Computational Modelling.

Osteoporosis leads to bone loss and structural deterioration, which increase the risk of fractures. The aim of this study was to characterize the three-dimensional (3D) bone mass distributions of the distal tibia in normal, osteopenic, and osteoporotic conditions. High-resolution peripheral quantitative computed tomography (HR-pQCT) of the 33 % of the distal tibia and local dual-energy X-ray absorptiometry were applied to 53 intact, fresh-frozen tibiae. The HR-pQCTs were graded to assign local T-scores and merged into three equally sized average normal, osteopenic, and osteoporotic surface models. Volumetric bone mineral density (vBMD) was determined using categorized T-scores, volumetric visualization, and virtual bore probes at the dia-, meta-, and epiphyseal sites (T-DIA, T-META, and T-EPI). We observed a distinct 3D bone mass distribution that was gradually uninfluenced by T-score categories. T-DIA was characterized by the lowest bone mass located in the medullary cavity and a wide homogenous cortex containing the maximum vBMD. The T-META showed decreased cortical thickness and maximal vBMD. At the T-EPI, the relatively low vBMD of the mostly trabecular bone was similar to the maximal cortical vBMD in this sub-region. Four trabecular regions of low bone mass were identified in the recesses. The bone content gradually decreased at all sites, whereas the pattern of bone mass distribution remained essentially unchanged, with the exception of disproportionate losses at T-DIA, T-META, and T-EPI that consistently showed increased endocortical, intracortical, and trabecular bone loss. Extra information can be obtained from the specific pattern of bone mass distribution, potential disproportionate bone losses, and method used.

The relevance of neutral arm positioning for true ap-view X-ray to provide true projection of the humeral head shaft angle.

INTRODUCTION: Textbooks commonly recommend using the true anterior-posterior (ap)-view with the patient's arm in a sling and therefore in internal rotation (IR) for radiologic diagnostic assessment of the proximal humerus after trauma. However, IR or external rotation (ER) may affect the projection of the head shaft angle (HSA) and therefore bias the diagnostic conclusion significantly. We hypothesized that neutral rotation (NR) of the arm is mandatory for true ap-view to provide true projection of the HSA. MATERIALS AND METHODS: A simplified geometrical model of the proximal humerus was used to examine the influence of different arm positions and angulations of the central ray in relation to the projection of the HSA. RESULTS: Both ER and IR misleadingly suggested an increased valgus angle. Simulating the true ap-view with the central ray in cranio-caudal direction, IR changed the projection of the HSA substantially. CONCLUSION: In conclusion, standard fixation of the patient's arm in a shoulder sling in IR for true ap-view may result in an oblique projection, potentially leading to incorrect surgical implications. To prevent misdiagnosed valgus or varus angulation, NR of the arm should be obeyed when performing true ap-view X-ray. We, therefore, highly recommend to overcome the traditionally arm position, ensuring the true amount of dislocation to assure correct surgical implications and comparable follow-up examinations.

A simple approach for the preoperative assessment of sacral morphology for percutaneous SI screw fixation.

BACKGROUND: Percutaneous sacroiliac screw fixation under fluoroscopic control is an effective method for posterior pelvic ring stabilization. However, sacral dysmorphism has a high risk of L5 nerve injury. This study describes a simple method for the preoperative assessment of the sacral morphology using CT scans with widely available tools. MATERIALS AND METHODS: CT scans of 1000 patients were analyzed. True inlet, outlet, and lateral views of the sacrum were obtained using a two-dimensional reconstruction tool to align the sacrum in a reproducible manner. Corridor morphology in the inlet view was measured to calculate different morphological types: (1) Ascending type, (2) Horizontal type, and (3) Descending type. In a second step, the corridor was analyzed for the presence of an anterior indentation of the sacrum between the SI joint and the midsagittal plane with proximity to the nerve root L5, which, therefore, may be harmed during screw misplacement. RESULTS: A notch was found in the majority of cases with relative frequencies ranging from 69 % (upper quartile of S1) to 95 % (upper quartile of S2). Descending types were, by far, the most frequent corridor type with one exception: In the upper quartile of S1, the ascending type was the most frequent corridor (71 %). Horizontal types were less frequent with a relative incidence between 2 and 14 %. DISCUSSION: This study should increase the awareness for sacral dysmorphism, emphasize the importance of a preoperative assessment of the osseous corridor, and provide a simple method for the preoperative assessment with widely available tools.

How to document and report orthopedic complications in clinical studies? A proposal for standardization.

INTRODUCTION: The documentation of complications is critical for the evaluation of therapeutic interventions in orthopedics. However, there is a lack of accepted methodological standardization and definitions. We propose a concept to support the consensus development of a standardized management and classification of complications in clinical research. METHODS: Complication events are examined regarding their clinical presentation, their timing of occurrence as well as their potential causal interrelationship for any given patient. Their clinical presentation is distinguished by their likely triggers, their therapeutic management, and their outcome. Complications are events (including relevant deviations from their expected healing process) that are harmful to patients and can be described as local to the treated injury/disease or systemic (when they affect the rest of the body). The treatment of a complication, e.g. by way of an unplanned surgical intervention, and its outcome should be carefully documented. Complication review boards with independent clinicians should be established to validate complication records. APPLICATION AND RELEVANCE: In this proposal, a number of complication examples are presented to illustrate the concept and demonstrate its practical use. This management and classification system has already proven valuable in the documentation and analysis of complication data from a number of published clinical studies. Because of this new standardized assessment process, it facilitates the communication of complications between clinicians and researchers, and helps to develop clear definitions for specific orthopedic complications.

Is there a difference in timing and cause of death after fractures in the elderly?

BACKGROUND: Patients who sustain osteoporotic fractures have excessive mortality compared to age-matched controls, which is most pronounced within the first 6 months postfracture. However, the timing and cause of death in the first 3 months after sustaining a fracture are unclear. QUESTIONS/PURPOSES: We therefore evaluated and compared the timing and cause of death in patients who sustained a pelvic, proximal femoral, spinal, or proximal humeral fracture 30 and 90 days after fracture. METHODS: From medical records, we recorded age at time of fracture, sex, fracture site, comorbidities, date of death, and cause of death of 1630 patients with 1630 fractures admitted to our department between 2001 and 2007. The median age at the time of fracture was 83 years and 89% of the patients were women. RESULTS: Fifty-eight patients died within 30 days after fracture (3.6%), and 122 patients (7.5%) died within 90 days after fracture. Cardiovascular causes of death were most frequent in all fracture groups. Patients who suffered from spinal fractures died earlier within 30 days after fracture than patients who suffered from other types of fractures. CONCLUSIONS: This shows the severity and impact of a spinal injury compared to other typical fragility fractures.

Study protocol: the effect of whole body vibration on acute unilateral unstable lateral ankle sprain- a biphasic randomized controlled trial.

BACKGROUND: Ankle sprains often result in ankle instability, which is most likely caused by damage to passive structures and neuromuscular impairment. Whole body vibration (WBV) is a neuromuscular training method improving those impaired neurologic parameters. The aim of this study is to compare the current gold standard functional treatment to functional treatment plus WBV in patients with acute unilateral unstable inversion ankle sprains. METHODS/DESIGN: 60 patients, aged 18-40 years, presenting with an isolated, unilateral, acute unstable inversion ankle sprain will be included in this bicentric, biphasic, randomized controlled trial. Samples will be randomized by envelope drawing. All patients will be allowed early mobilization and pain-dependent weight bearing, limited functional immobilization by orthosis, PRICE, NSARDs as well as home and supervised physiotherapy. Supervised physical therapy will take place twice a week, for 30 minutes for a period of 6 weeks, following a standardized intervention protocol. During supervised physical therapy, the intervention group will perform exercises similar to those of the control group, on a side-alternating sinusoidal vibration platform. Two time-dependent primary outcome parameters will be assessed: short-term outcome after six weeks will be postural control quantified by the sway index; mid-term outcome after one year will be assessed by subjective instability, defined by the presence of giving-way attacks. Secondary outcome parameters include: return to pre-injury level of activities, residual pain, recurrence, objective instability, energy/coordination, Foot and Ankle Disability Index and EQ 5D. DISCUSSION: This is the first trial investigating the effects of WBV in patients with acute soft tissue injury. Inversion ankle sprains often result in ankle instability, which is most likely due to damage of neurological structures. Due to its unique, frequency dependent, influence on various neuromuscular parameters, WBV is a promising treatment method for patients with acute unstable inversion ankle sprains. TRIAL REGISTRATION: NCT01702597.

Comparing the volume of vascular intersection of two femoral neck fracture fixation implants using an In silico technique.

Femoral neck fracture displacement with subsequent vascular disruption is one of the factors that contribute to trauma-induced avascular necrosis of the femoral head. Iatrogenic damage of the intraosseous arterial system during fixation of femoral neck fracture is another possible cause of avascular necrosis that is less well understood. Recently, Zhao et al (2017) reconstructed 3D structures of intraosseous blood supply and identified the epiphyseal and inferior retinacular arterial system to be important structures for maintaining the femoral head blood supply after femoral neck fracture. The authors therefore recommended placing implants centrally to reduce iatrogenic vascular injuries. Our in vitro study compared the spatial footprint of a traditional dynamic hip screw with an antirotation screw versus a newly developed hip screw with an integrated antirotation screw on intraosseous vasculature. Methods: Three dimensional (3D) µCT angiograms of 9 cadaveric proximal femora were produced. Three segmented volumes-porous or cancellous bone, filled or cortical bone, and intraosseous vasculature-were converted to surface files. 3D in silico models of the fixation systems were sized and implanted in silico without visibility of the vascular maps. The volume of vasculature that overlapped with the devices was determined. The ratio of the vascular intersection to the comparator device was calculated, and the mean ratio was determined. A paired design, noninferiority test was used to compare the devices. Results: Results indicate both significant (P < 0.001) superiority and noninferiority of the hip screw with an integrated antirotation screw when compared with a dynamic hip screw and antirotation screw for the volume of vasculature that overlapped with each device in the femoral neck. Conclusions: Combining established methods of vascular visualization with newer methods enables an implant's impact on vascular intersection to be assessed in silico. This methodology suggests that when used for femoral neck fracture management, the new device intersects fewer blood vessels than the comparator. Comparative clinical studies are needed to investigate whether these findings correlate with the incidence of avascular necrosis and clinical outcomes.

Risk factors and healthcare costs associated with long bone fracture non-union: a retrospective US claims database analysis.

BACKGROUND: Few contemporary US-based long bone non-union analyses have recently been published. Our study was designed to provide a current understanding of non-union risks and costs, from the payers' perspective. METHODS: The Merative™ MarketScan® Commercial Claims and Encounters database was used. Patients with surgically treated long bone (femur, tibia, or humerus) fractures in the inpatient setting, from Q4 2015 to most recent, were identified. Exclusion criteria included polytrauma and amputation at index. The primary outcome was a diagnosis of non-union in the 12 and 24 months post-index. Additional outcomes included concurrent infection, reoperation, and total healthcare costs. Age, gender, comorbidities, fracture characteristics, and severity were identified for all patients. Descriptive analyses were performed. Crude and adjusted rates of non-union (using Poisson regressions with log link) were calculated. Marginal incremental cost of care associated with non-union and infected non-union and reoperation were estimated using a generalized linear model with log link and gamma distribution. RESULTS: A total of 12,770, 13,504, and 4,805 patients with femoral, tibial, or humeral surgically treated fractures were identified, 74-89% were displaced, and 18-27% were comminuted. Two-year rates of non-union reached 8.5% (8.0%-9.1%), 9.1% (8.6%-9.7%), and 7.2% (6.4%-8.1%) in the femoral, tibial, and humeral fracture cohorts, respectively. Shaft fractures were at increased risk of non-union versus fractures in other sites (risk ratio (RR) in shaft fractures of the femur: 2.36 (1.81-3.04); tibia: 1.95 (1.47-2.57); humerus: 2.02 (1.42-2.87)). Fractures with severe soft tissue trauma (open vs. closed, Gustilo III vs. Gustilo I-II) were also at increased risk for non-union (RR for Gustilo III fracture (vs. closed) for femur: R = 1.96 (1.45-2.58), for tibia: 3.33 (2.85-3.87), RR for open (vs. closed) for humerus: 1.74 (1.30-2.32)). For all fractures, younger patients had a reduced risk of non-union compared to older patients. For tibial fractures, increasing comorbidity (Elixhauser Index 5 or greater) was associated with an increased risk of non-union. The two-year marginal cost of non-union ranged from $33K-$45K. Non-union reoperation added $16K-$34K in incremental costs. Concurrent infection further increased costs by $46K-$86K. CONCLUSIONS: Non-union affects 7-10% of surgically treated long bone fracture cases. Shaft and complex fractures were at increased risk for non-union.

Precision of bone mechanoregulation assessment in humans using longitudinal high-resolution peripheral quantitative computed tomography in vivo.

Local mechanical stimuli in the bone microenvironment are essential for the homeostasis and adaptation of the skeleton, with evidence suggesting that disruption of the mechanically-driven bone remodelling process may lead to bone loss. Longitudinal clinical studies have shown the combined use of high-resolution peripheral quantitative computed tomography (HR-pQCT) and micro-finite element analysis can be used to measure load-driven bone remodelling in vivo; however, quantitative markers of bone mechanoregulation and the precision of these analyses methods have not been validated in human subjects. Therefore, this study utilised participants from two cohorts. A same-day cohort (n = 33) was used to develop a filtering strategy to minimise false detections of bone remodelling sites caused by noise and motion artefacts present in HR-pQCT scans. A longitudinal cohort (n = 19) was used to develop bone imaging markers of trabecular bone mechanoregulation and characterise the precision for detecting longitudinal changes in subjects. Specifically, we described local load-driven formation and resorption sites independently using patient-specific odds ratios (OR) and 99 % confidence intervals. Conditional probability curves were computed to link the mechanical environment to the remodelling events detected on the bone surface. To quantify overall mechanoregulation, we calculated a correct classification rate measuring the fraction of remodelling events correctly identified by the mechanical signal. Precision was calculated as root-mean-squared averages of the coefficient of variation (RMS-SD) of repeated measurements using scan-rescan pairs at baseline combined with a one-year follow-up scan. We found no significant mean difference (p < 0.01) between scan-rescan conditional probabilities. RMS-SD was 10.5 % for resorption odds, 6.3 % for formation odds, and 1.3 % for correct classification rates. Bone was most likely to be formed in high-strain and resorbed in low-strain regions for all participants, indicating a consistent, regulated response to mechanical stimuli. For each percent increase in strain, the likelihood of bone resorption decreased by 2.0 ± 0.2 %, and the likelihood of bone formation increased by 1.9 ± 0.2 %, totalling 38.3 ± 1.1 % of strain-driven remodelling events across the entire trabecular compartment. This work provides novel robust bone mechanoregulation markers and their precision for designing future clinical studies.

Prospective randomized multicenter noninferiority clinical trial evaluating the use of TFN-advancedTM proximal femoral nailing system (TFNA) for the treatment of proximal femur fracture in a Chinese population.

PURPOSE: To evaluate whether the 24-weeks postoperative fracture union rate for the investigational TFNA intramedullary nail was non-inferior compared to the control product PFNA-II. METHODS: The study was a prospective, randomized, single-blind, noninferiority dual-arm study drawing from 9 trauma centers across China, between November 2018 and September 2020, with follow-up measurements at 24 weeks after internal fixation. The full analysis data set (FAS [Intent-to-Treat]) was analyzed and is summarized here. The primary outcome was fracture union rate, a composite score combining clinical and radiographic assessment. Secondary endpoints comprised (a) clinical outcomes including (1) SF-12, (2) Harris Hip, and (3) EQ-5D Scores, (b) radiographic incidence of complications such as loosening or cut-out requiring revision, (c) revision rates, (d) reoperation rates, and (e) adverse events, including 24-weeks revision and reoperation rates. RESULTS: Both TFNA and PFNA-II group fracture healing rates were 100% at 24 weeks; TFNA was therefore shown to be non-inferior to PFNA-II. With baseline data matched in all parameters except age in both the TFNA and PFNA-II groups, comparisons of union rates, SF-12, Harris Hip, and EQ-5D Scores yielded p values > 0.05 indicating no significant difference between the two groups, further supporting the noninferiority of TFNA. In both groups, revision and re-operation rates were 0, and the incidences of serious adverse events were 19.4% and 17.4%, respectively. CONCLUSION: In terms of fracture union rate at 24 weeks, the DePuy Synthes Trochanteric Fixation Nail Advanced (TFNA) was not inferior to the marketed Proximal Femoral Nail Antirotation (PFNA-II) device produced by the same manufacturer. Secondary and safety outcomes showed no significant differences between the two groups. REGISTRATION: Registration was completed at ClinicalTrials.gov NCT03635320.