Mixed reality visualization in shoulder arthroplasty: is it better than traditional preoperative planning software?

Background Preoperative traditional software planning (TSP) is a method used to assist surgeons with implant selection and glenoid guide-pin insertion in shoulder arthroplasty. Mixed reality (MR) is a new technology that uses digital holograms of the preoperative plan and guide-pin trajectory projected into the operative field. The purpose of this study was to compare TSP to MR in a simulated surgical environment involving insertion of guide-pins into models of severely deformed glenoids. Methods Eight surgeons inserted guide-pins into eight randomized three-dimensional-printed severely eroded glenoid models in a simulated surgical environment using either TSP or MR. In total, 128 glenoid models were used and statistically compared. The outcomes compared between techniques included procedural time, difference in guide-pin start point, difference in version and inclination, and surgeon confidence via a confidence rating scale. Results When comparing traditional preoperative software planning to MR visualization as techniques to assist surgeons in glenoid guide pin insertion, there were no statistically significant differences in terms of mean procedure time (P=0.634), glenoid start-point (TSP=2.2±0.2 mm, MR=2.1±0.1 mm; P=0.760), guide-pin orientation (P=0.586), or confidence rating score (P=0.850). Conclusions The results demonstrate that there were no significant differences between traditional preoperative software planning and MR visualization for guide-pin placement into models of eroded glenoids. A perceived benefit of MR is the real-time intraoperative visibility of the surgical plan and the patient’s anatomy; however, this did not translate into decreased procedural time or improved guide-pin position. Level of evidence Basic science study, biomechanics

A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: The RAMBO trial

Background: The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits. Methods/Design. The RAMBO trial (Radial Head - Amsterdam - Amphia - Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the 'Disabilities of Arm, Shoulder and Hand (DASH) score' twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the 'Numeric Rating Scale', range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year. Discussion. The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head. Trial registration. The trial is registered at the Dutch Trial Register: NTR3413

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

PANC Study (Pancreatitis: A National Cohort Study): national cohort study examining the first 30 days from presentation of acute pancreatitis in the UK

Abstract Background Acute pancreatitis is a common, yet complex, emergency surgical presentation. Multiple guidelines exist and management can vary significantly. The aim of this first UK, multicentre, prospective cohort study was to assess the variation in management of acute pancreatitis to guide resource planning and optimize treatment. Methods All patients aged greater than or equal to 18 years presenting with acute pancreatitis, as per the Atlanta criteria, from March to April 2021 were eligible for inclusion and followed up for 30 days. Anonymized data were uploaded to a secure electronic database in line with local governance approvals. Results A total of 113 hospitals contributed data on 2580 patients, with an equal sex distribution and a mean age of 57 years. The aetiology was gallstones in 50.6 per cent, with idiopathic the next most common (22.4 per cent). In addition to the 7.6 per cent with a diagnosis of chronic pancreatitis, 20.1 per cent of patients had a previous episode of acute pancreatitis. One in 20 patients were classed as having severe pancreatitis, as per the Atlanta criteria. The overall mortality rate was 2.3 per cent at 30 days, but rose to one in three in the severe group. Predictors of death included male sex, increased age, and frailty; previous acute pancreatitis and gallstones as aetiologies were protective. Smoking status and body mass index did not affect death. Conclusion Most patients presenting with acute pancreatitis have a mild, self-limiting disease. Rates of patients with idiopathic pancreatitis are high. Recurrent attacks of pancreatitis are common, but are likely to have reduced risk of death on subsequent admissions. </jats:sec

Breast cancer management pathways during the COVID-19 pandemic: outcomes from the UK ‘Alert Level 4’ phase of the B-MaP-C study

Abstract: Background: The B-MaP-C study aimed to determine alterations to breast cancer (BC) management during the peak transmission period of the UK COVID-19 pandemic and the potential impact of these treatment decisions. Methods: This was a national cohort study of patients with early BC undergoing multidisciplinary team (MDT)-guided treatment recommendations during the pandemic, designated ‘standard’ or ‘COVID-altered’, in the preoperative, operative and post-operative setting. Findings: Of 3776 patients (from 64 UK units) in the study, 2246 (59%) had ‘COVID-altered’ management. ‘Bridging’ endocrine therapy was used (n = 951) where theatre capacity was reduced. There was increasing access to COVID-19 low-risk theatres during the study period (59%). In line with national guidance, immediate breast reconstruction was avoided (n = 299). Where adjuvant chemotherapy was omitted (n = 81), the median benefit was only 3% (IQR 2–9%) using ‘NHS Predict’. There was the rapid adoption of new evidence-based hypofractionated radiotherapy (n = 781, from 46 units). Only 14 patients (1%) tested positive for SARS-CoV-2 during their treatment journey. Conclusions: The majority of ‘COVID-altered’ management decisions were largely in line with pre-COVID evidence-based guidelines, implying that breast cancer survival outcomes are unlikely to be negatively impacted by the pandemic. However, in this study, the potential impact of delays to BC presentation or diagnosis remains unknown

The effect of inhomogeneous trabecular stiffness relationship selection on finite element outcomes for shoulder arthroplasty

Copyright © 2019 by ASME. An important feature of humeral orthopedic finite element (FE) models is the trabecular stiffness relationship. These relationships depend on the anatomic site from which they are derived; but have not been developed for the humerus. As a consequence, humeral FE modeling relies on relationships for other anatomic sites. The variation in humeral FE outcomes due to the trabecular stiffness relationship is assessed. Stemless arthroplasty FE models were constructed from CT scans of eight humeri. Models were loaded corresponding to 45 deg and 75 deg abduction. Each bone was modeled five times with the only variable being the trabecular stiffness relationship: four derived from different anatomic-sites and one pooled across sites. The FE outcome measures assessed were implant-bone contact percentage, von Mises of the change in stress, and bone response potential. The variance attributed to the selection of the trabecular stiffness relationship was quantified as the standard deviation existing between models of different trabecular stiffness. Overall, variability due to changing the trabecular stiffness relationship was low for all humeral FE outcome measures assessed. The variability was highest within the stress and bone formation potential outcome measures of the trabecular region. Variability only exceeded 10% in the trabecular stress change within two of the eight slices evaluated. In conclusion, the low variations attributable to the selection of a trabecular stiffness relationship based on anatomic-site suggest that FE models constructed for shoulder arthroplasty can utilize an inhomogeneous site-pooled trabecular relationship without inducing marked variability in the assessed outcome measures

Comparing daily shoulder motion and frequency after anatomic and reverse shoulder arthroplasty

© 2017 Journal of Shoulder and Elbow Surgery Board of Trustees Background Both anatomic (TSA) and reverse total shoulder arthroplasty (RTSA) are common interventions for glenohumeral arthrosis, with the goal of relieving pain and restoring mobility. Understanding shoulder arthroplasty motion and frequency is of interest in evaluating effectiveness and in predicting bearing wear for implant development and optimization. The purpose of this study was to measure and compare the total daily shoulder motion of patients after TSA and RTSA. Methods Thirty-six human subjects who had undergone shoulder arthroplasty wore a custom instrumented garment that tracked upper extremity motion for the waking hours of 1 day. The 3-dimensional orientation of each humeral sensor was transformed with respect to the torso to calculate total joint motion and frequency, with comparison of TSA to RTSA. In addition, the yearly motion of the shoulder was extrapolated. Results The majority of shoulder motion occurred below 80° of elevation (P \u3c.001), totaling on average 821 ± 45 and 783 ± 27 motions per hour for TSA and RTSA, respectively. Conversely, elevations \u3e80° were significantly less frequent, totaling only 52 ± 44 (P \u3c.001) and 38 ± 27 (P \u3c.001) motions per hour for TSA and RTSA, respectively. No significant differences were detected between TSA and RTSA shoulders (P =.22) or their respective contralateral asymptomatic sides (P =.64, P =.62). When extrapolated, it was estimated that each TSA and RTSA shoulder elevated above 60° approximately 1 million and 0.75 million cycles per year, respectively. Discussion Mean shoulder motions after TSA or RTSA were not significantly different from the contralateral asymptomatic side. In addition, no significant differences were detected in shoulder motion or frequency between TSA and RTSA

Tribocorrosion in shoulder arthroplasty humeral component retrievals

© 2016 Journal of Shoulder and Elbow Surgery Board of Trustees. Background: Tribocorrosion at the modular taper connections of total hip implants has been associated with trunnionosis and adverse local tissue reactions. Modularity is also widely used in shoulder arthroplasty implants, but little information exists about the potential for tribocorrosion. This study hypothesized that there would be mild or no tribocorrosion in a series of retrieved shoulder implants. Methods: A total of 28 implants with a mean implantation time of 6.2 ± 6.0 years were evaluated using a validated damage scoring method. Implant tapers on the head and stem were divided into upper (deepest) and lower zones and independently scored for fretting and corrosion damage from 1 (none) to 4 (severe). Results: Corrosion was present on 32% of heads and 38% of stems, whereas fretting was present on 36% of heads and 46% of stems. There was significantly greater (P = .02) corrosion in the lower zone of the retrieved stems (1.4 ± 0.5) than there was in the upper zone (1.1 ± 0.3). Correlation between the head and stem corrosion for lower zone was moderate (r = 0.41; P = .04). Discussion: Tribocorrosion was present on the heads and stems of some of the retrieved shoulder implants examined in this study. The incidence of tribocorrosion in shoulder implants was lower than in reported cases of retrieved hip implants. The greatest damage was in the lower zone of the taper, where the connection may be exposed to the surrounding joint fluid. It remains to be seen whether this leads to any clinical presentation of trunnionosis

Implant Design Variations in Reverse Total Shoulder Arthroplasty Influence the Required Deltoid Force and Resultant Joint Load

© 2015, The Association of Bone and Joint Surgeons®. Background: Reverse total shoulder arthroplasty (RTSA) is widely used; however, the effects of RTSA geometric parameters on joint and muscle loading, which strongly influence implant survivorship and long-term function, are not well understood. By investigating these parameters, it should be possible to objectively optimize RTSA design and implantation technique. Questions/purposes: The purposes of this study were to evaluate the effect of RTSA implant design parameters on (1) the deltoid muscle forces required to produce abduction, and (2) the magnitude of joint load and (3) the loading angle throughout this motion. We also sought to determine how these parameters interacted. Methods: Seven cadaveric shoulders were tested using a muscle load-driven in vitro simulator to achieve repeatable motions. The effects of three implant parameters—humeral lateralization (0, 5, 10 mm), polyethylene thickness (3, 6, 9 mm), and glenosphere lateralization (0, 5, 10 mm)—were assessed for the three outcomes: deltoid muscle force required to produce abduction, magnitude of joint load, and joint loading angle throughout abduction. Results: Increasing humeral lateralization decreased deltoid forces required for active abduction (0 mm: 68% ± 8% [95% CI, 60%–76% body weight (BW)]; 10 mm: 65% ± 8% [95% CI, 58%–72 % BW]; p = 0.022). Increasing glenosphere lateralization increased deltoid force (0 mm: 61% ± 8% [95% CI, 55%–68% BW]; 10 mm: 70% ± 11% [95% CI, 60%–81% BW]; p = 0.007) and joint loads (0 mm: 53% ± 8% [95% CI, 46%–61% BW]; 10 mm: 70% ± 10% [95% CI, 61%–79% BW]; p \u3c 0.001). Increasing polyethylene cup thickness increased deltoid force (3 mm: 65% ± 8% [95% CI, 56%–73% BW]; 9 mm: 68% ± 8% [95% CI, 61%–75% BW]; p = 0.03) and joint load (3 mm: 60% ± 8% [95% CI, 53%–67% BW]; 9 mm: 64% ± 10% [95% CI, 56%–72% BW]; p = 0.034). Conclusions: Humeral lateralization was the only parameter that improved joint and muscle loading, whereas glenosphere lateralization resulted in increased loads. Humeral lateralization may be a useful implant parameter in countering some of the negative effects of glenosphere lateralization, but this should not be considered the sole solution for the negative effects of glenosphere lateralization. Overstuffing the articulation with progressively thicker humeral polyethylene inserts produced some adverse effects on deltoid muscle and joint loading. Clinical Relevance: This systematic evaluation has determined that glenosphere lateralization produces marked negative effects on loading outcomes; however, the importance of avoiding scapular notching may outweigh these effects. Humeral lateralization’s ability to decrease the effects of glenosphere lateralization was promising but further investigations are required to determine the effects of combined lateralization on functional outcomes including range of motion

The effect of glenosphere diameter in reverse shoulder arthroplasty on muscle force, joint load, and range of motion

© 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Background: Little is known about the effects of glenosphere diameter on shoulder joint loads. The purpose of this biomechanical study was to investigate the effects of glenosphere diameter on joint load, load angle, and total deltoid force required for active abduction and range of motion in internal/external rotation and abduction. Methods: A custom, instrumented reverse shoulder arthroplasty implant system capable of measuring joint load and varying glenosphere diameter (38 and 42mm) and glenoid offset (neutral and lateral) was implanted in 6 cadaveric shoulders to provide at least 80% power for all variables. A shoulder motion simulator was used to produce active glenohumeral and scapulothoracic motion. All implant configurations were tested with active and passive motion with joint kinematics, loads, and moments recorded. Results: At neutral and lateralized glenosphere positions, increasing diameter significantly increased joint load (+12±21 N and +6 ± 9 N; P\u3c.01) and deltoid load required for active abduction (+9±22 N and +11±15 N; P\u3c.02), whereas joint load angle was unaffected (. P\u3e.8). Passive internal rotation was reduced with increased diameter at both neutral and lateralized glenosphere positions (-6° ± 6° and -12°±6°; P\u3c.002); however, external rotation was not affected (. P\u3e.05). At neutral glenosphere position, increasing diameter increased the maximum angles of both adduction (+1°±1°; P=.03) and abduction (+8°±9°; P\u3c.05). Lateralization also increased abduction range of motion compared with neutral (. P\u3c.01). Conclusions: Although increasing glenosphere diameter significantly increased joint load and deltoid force, the clinical impact of these changes is presently unclear. Internal rotation, however, was reduced, which contradicts previous bone modeling studies, which we postulate is due to increased posterior capsular tension as it is forced to wrap around a larger 42 mm implant assembly