45 research outputs found
Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds
In this ongoing study, substantially increased ancestral SARSCoV-2 neutralizing responses were observed 1 month after a third 10-µg BNT162b2 dose given to 5 to 11-year olds versus neutralizing responses post-dose 2. After dose 3, increased neutralizing responses against Omicron BA.1 and BA.4/BA.5 strains were also observed. The safety/tolerability profile was acceptable.Peer reviewe
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Peginterferon Alfa-2b or Alfa-2a with Ribavirin for Treatment of Hepatitis C Infection
Background
Treatment guidelines recommend the use of peginterferon alfa-2b or peginterferon alfa-2a in combination with ribavirin for chronic hepatitis C virus (HCV) infection. However, these regimens have not been adequately compared.
Methods
At 118 sites, patients who had HCV genotype 1 infection and who had not previously been treated were randomly assigned to undergo 48 weeks of treatment with one of three regimens: peginterferon alfa-2b at a standard dose of 1.5 μg per kilogram of body weight per week or a low dose of 1.0 μg per kilogram per week, plus ribavirin at a dose of 800 to 1400 mg per day, or peginterferon alfa-2a at a dose of 180 μg per week plus ribavirin at a dose of 1000 to 1200 mg per day. We compared the rate of sustained virologic response and the safety and adverse-event profiles between the peginterferon alfa-2b regimens and between the standard-dose peginterferon alfa- 2b regimen and the peginterferon alfa-2a regimen.
Results
Among 3070 patients, rates of sustained virologic response were similar among the regimens: 39.8% with standard-dose peginterferon alfa-2b, 38.0% with low-dose peginterferon alfa-2b, and 40.9% with peginterferon alfa-2a (P=0.20 for standarddose vs. low-dose peginterferon alfa-2b; P=0.57 for standard-dose peginterferon alfa-2b vs. peginterferon alfa-2a). Estimated differences in response rates were 1.8% (95% confidence interval [CI], −2.3 to 6.0) between standard-dose and low-dose peginterferon alfa-2b and −1.1% (95% CI, −5.3 to 3.0) between standard-dose peginterferon alfa-2b and peginterferon alfa-2a. Relapse rates were 23.5% (95% CI, 19.9 to 27.2) for standard-dose peginterferon alfa-2b, 20.0% (95% CI, 16.4 to 23.6) for lowdose peginterferon alfa-2b, and 31.5% (95% CI, 27.9 to 35.2) for peginterferon alfa- 2a. The safety profile was similar among the three groups; serious adverse events were observed in 8.6 to 11.7% of patients. Among the patients with undetectable HCV RNA levels at treatment weeks 4 and 12, a sustained virologic response was achieved in 86.2% and 78.7%, respectively.
Conclusions
In patients infected with HCV genotype 1, the rates of sustained virologic response and tolerability did not differ significantly between the two available peginterferon– ribavirin regimens or between the two doses of peginterferon alfa-2b. (ClinicalTrials. gov number, NCT00081770.
The Antibiotic Nail in the Treatment of Long Bone Infection: Technique and Results.
Antibiotic cement nails provide a useful and relatively simple technique to treat intramedullary osteomyelitis of the long bones. These devices provide stability as well as local, targeted antibiotics, which are both critical aspects of osteomyelitis management. Additionally, the use of a threaded core is a critical component of successful cement nail assembly. With adherence to the simple principles outlined in this review, surgeons can expect reliably good results using these drug-delivery implants
Low Incidence of Neurovascular Complications After Placement of Proximal Tibial Traction Pins.
Skeletal tibial traction is a temporizing measure used preoperatively for femoral fractures to improve the length and alignment of the limb and provide pain relief. The goal of this study was to identify possible neurovascular morbidity associated with the use of bedside skeletal tibial traction to treat femur fractures. All femoral fractures treated with proximal tibial traction during a 10-year period at an urban level I trauma center were retrospectively reviewed. The medical record was reviewed to determine whether a pin-related complication had occurred. Records also were reviewed to identify ipsilateral multi-ligamentous knee injuries that were not diagnosed until after the application of traction. In total, 303 proximal tibial traction pins were placed. A total of 7 (2.3%; 95% confidence interval, 0.60%-4.0%) pin-related neurologic complications and zero vascular complications were noted. All complications involved motor and/or sensory deficits in the distribution of the peroneal nerve. Of the 7 complications, 6 resolved fully after surgery and removal of the pin. After traction placement, 6 (2.0%) ipsilateral multiligamentous knee injuries were diagnosed. None of these patients had a neurovascular complication. This study suggests that bedside placement of proximal tibial traction for femoral fractures is associated with a low incidence of neurovascular complications and that traction can be safely placed at the bedside by residents. A thorough neurovascular examination should be performed before insertion, and care should be taken to identify the proper starting point and reduce soft tissue trauma during pin placement. [Orthopedics. 2017; 40(6):e1004-e1008.]
Divergent elbow dislocation with radial shaft fracture, distal ulnar deformation, and distal radioulnar joint instability: an unclassifiable Monteggia variant
Originally described by Monteggia and later classified by Bado, elbow dislocations with concurrent radial and ulnar shaft fractures with distal radioulnar joint (DRUJ) disruption are considered operative cases with high-energy injurious etiologies. Here, we present an unclassifiable Monteggia variant fracture suffered through a high axial load mechanism in a 47-year-old female. The fracture pattern initially exhibited included a divergent elbow dislocation, a radial shaft fracture, plastic deformation of the distal ulna, and DRUJ instability. Here we describe the pattern in detail, along with definitive treatment and clinical outcome at 1Â year follow-up
Inadvertent Reduction of Symphyseal Diastasis During Computed Tomography.
OBJECTIVE: To determine the quantifiable difference in pubic symphysis diastasis when comparing computed tomography (CT) and pelvic radiographs in individuals with anterior pelvic ring injuries.
DESIGN: Retrospective chart and radiographic review.
SETTING: Level 1 trauma center.
PATIENTS/PARTICIPANTS: Between 2002 and 2013, all individuals requiring internal fixation of the anterior pelvic ring were reviewed. Of the 163 patients, 72 met the inclusion criteria. Patients with a symphysis dislocation were included if the pelvic radiograph and CT were performed without a pelvic binder, and imaging was adequate for required measurements.
INTERVENTION: Symphyseal diastasis was measured on the initial pelvic radiograph, the CT scout, and axial views.
MAIN OUTCOME MEASUREMENTS: Comparison of measured symphyseal diastasis on CT and pelvic radiographs.
RESULTS: Seventy-two patients met the inclusion criteria. Ninety-seven percent (70/72) had a reduction of their symphysis diastasis in the CT with an average reduction of 6.6 mm (Range, -2.6 to 35.5 mm). The average diastasis on radiograph was 26.3 mm compared with 19.7 mm on CT scout (P \u3c 0.001). Fourteen patients (19.2%) had a reduction from greater than 25 mm to less than 25 mm-a traditional cutoff for operative intervention.
CONCLUSIONS: The anteroposterior pelvis radiograph remains an important part of the workup for trauma patients. Reliance on CT alone may underestimate the true degree of pelvic displacement. Failure to obtain pelvic radiographs in the acute setting limits the information in which the medical team can base both immediate and definitive decisions about pelvic ring injuries.
LEVEL OF EVIDENCE: Diagnostic level III. See Instructions for Authors for a complete description of levels of evidence
Associated Injuries in Skeletally Immature Children with Pelvic Fractures.
BACKGROUND: Pediatric pelvic fractures are rare injuries resulting from high-energy mechanisms that warrant an extensive work-up for associated injuries.
OBJECTIVES: We performed a retrospective study to review concomitant injuries in children who suffered a pelvic fracture and have an open triradiate cartilage.
METHODS: Using a database, pediatric pelvic fractures presenting to the authors\u27 institution were extracted. Radiographs and computed tomography scans were reviewed, ensuring that triradiate cartilages were not fused and the pelvic injuries were classified using the Modified Torode Classification. Epidemiologic data extracted included Glasgow Coma Scale (GCS), Injury Severity Score (ISS), and Abbreviated Injury Score (AIS).
RESULTS: Sixty patients met the inclusion criteria, and their average age was 8.3 years (range 2-14 years). There were no mortalities. The most common mechanism of injury was a vehicle striking a pedestrian. There were no significant correlations between GCS, ISS, and AIS. All 60 children (100%) suffered extremity injuries. Nineteen patients required surgical orthopedic intervention, and 6 required operative stabilization of the pelvis. Patients who were struck by a motor vehicle were more likely to have multiple pelvic fractures (p \u3c 0.05). Patients with multiple pelvic fractures were more likely to require orthopaedic surgical intervention and require a blood transfusion (p \u3c 0.05). Patients who had type III-B or IV fractures were more likely to require a transfusion than patients with III-A fracture (p \u3c 0.05).
CONCLUSIONS: Patients sustaining fractures to an immature pelvis are likely to have additional injuries, which may be fatal or disabling if not diagnosed in a timely manner
Evaluation of Intra-articular Fracture Extension After Gunshot Wounds to the Lower Extremity: Plain Radiographs Versus Computer Tomography.
OBJECTIVE: This study was to compare the use of computer tomography with plain radiographs for the evaluation of intra-articular extension of long bone fractures in the lower extremity after low-energy gunshot wounds.
DESIGN: Retrospective chart and radiographic review.
SETTING: Level 1 Trauma Center.
PATIENTS/PARTICIPANTS: Data were collected from a single institution from 2000 to 2014. Inclusion criteria consisted of patients greater than 17 years of age, low-velocity gunshot injuries causing fracture of the femur or tibia, plain radiographs with adequate films, and computed tomography (CT) imaging of the fracture. This consisted of 133 patients with 140 fractures.
INTERVENTION: Intra-articular fracture extension was evaluated on initial plain radiographs and CTs.
MAIN OUTCOME MEASURES: Comparison of gold standard CT with all reviewers\u27 evaluation of plain radiographs.
RESULTS: There were 140 total fractures; 108 were femoral fractures and 32 were tibial fractures. By comparing plain radiographs with the gold standard CT, the reviewers demonstrated correct diagnosis in 85% of intra-articular fractures and 96% of non-intra-articular fractures. In addition, the reviewers accurately diagnosed 70.8% of intra-articular extensions in the diaphysis and 70.5% in the metaphysis. The sensitivity and specificity for plain radiographs were 85.3% and 96.0%, respectively, for all locations. Metaphyseal and diaphyseal fractures demonstrated the poorest sensitivity at 80.7% and 82.1%, respectively.
CONCLUSIONS: Low-energy gunshot wounds with fractures in the diaphyseal of the distal femur and all metaphyseal fractures warrant CT evaluation to better examine for intra-articular fracture extension.
LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence
Patella fracture fixation with a non-locked anterior plating technique: A biomechanical study.
OBJECTIVES: The purpose of this study was to compare the biomechanical attributes of patella fracture fixation with either anterior plating utilizing two parallel, longitudinal 2.0 mm plates technique versus a cannulated screw tension band technique.
METHODS: Five matched pairs (ten specimens) of fresh frozen cadavers were utilized. A transverse patella fracture (OTA 34C1.1) was fixed using either two 4.0 mm cannulated screw anterior tension band (CATB) or with two 2.0 mm stainless steel non-locking plates along the anterior cortex secured with 2.4 mm cortical screws traversing the fracture site. Specimens underwent 1000 cycles of simulated active knee range of motion before load to failure destructive testing.
RESULTS: During cyclic loading there were no failures in the plate fixation group, and 2 out of 5 specimens catastrophically failed in the CATB group (p = 0.22). Average fracture displacement at the end of fatigue testing was 0.96 mm in the plate fixation group and 2.72 mm in the CATB group (p = 0.18). The specimens that withstood cyclic testing underwent a destructive load. Mean load to failure for the plate fixation specimens was 1286 N, which was not significantly different from the CATB group mean of 1175 N (p = 0.48). The mechanism of failure in the plate fixation cohort was uniformly via a secondary vertical patella fracture around the plates in all five specimens. In the CATB group, the mechanism of failure was via wire elongation and backing out of the screws.
CONCLUSIONS: Patella fixation with anterior plating technique statistically performed equivalent to cannulated screw anterior tension band in ultimate load to failure strength and fatigue endurance under cyclical loading. No failures were observed cyclic simulated active range of motion in the anterior plate group. There was a trend towards improved fatigue endurance in the plate fixation group, however this did not reach statistical significance. We believe plate fixation technique represents a low-profile implant option for treatment of transverse patella fractures, which may allow for early active range of motion, and these data support biomechanical equivalency to standard of care