Objective: To assess whether fixation method and vitamin D supplementation impact the risk of patient important outcomes within 12 months of injury in non-geriatric femoral neck fracture patients. Design: Pilot factorial randomized controlled trial. Setting: 15 North American clinical sites. Participants: 91 adults aged 18-60 years with a femoral neck fracture requiring surgical fixation. Intervention: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D 3 4,000 IU daily versus placebo for 6 months). Main Outcome Measurements: The primary clinical outcome was a composite of patient important complications (re-operation, femoral head osteonecrosis, severe femoral neck malunion, nonunion). Secondary outcomes included fracture healing complications and radiographic fracture healing.
IMPORTANCE Numerous studies have demonstrated that long-term outcomes after orthopedic trauma are associated with psychosocial and behavioral health factors evident early in the patient's recovery. Little is known about how to identify clinically actionable subgroups within this population.OBJECTIVES To examine whether risk and protective factors measured at 6 weeks after injury could classify individuals into risk clusters and evaluate whether these clusters explain variations in 12-month outcomes.
IMPORTANCE Despite the widespread use of systemic antibiotics to prevent infections in surgically treated patients with fracture, high rates of surgical site infection persist.OBJECTIVE To examine the effect of intrawound vancomycin powder in reducing deep surgical site infections.
DESIGN, SETTING, AND PARTICIPANTSThis open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers.INTERVENTIONS A standard infection prevention protocol with (n = 481) or without (n = 499) 1000 mg of intrawound vancomycin powder.
MAIN OUTCOMES AND MEASURESThe primary outcome was a deep surgical site infection within 182 days of definitive fracture fixation. A post hoc comparison assessed the treatment effect on gram-positive and gram-negative-only infections. Other secondary outcomes included superficial surgical site infection, nonunion, and wound dehiscence.
RESULTSThe analysis included 980 patients (mean [SD] age, 45.7 [13.7] years; 617 [63.0%] male) with 91% of the expected person-time of follow-up for the primary outcome. Within 182 days, deep surgical site infection was observed in 29 of 481 patients in the treatment group and 46 of 499 patients in the control group. The time-to-event estimated probability of deep infection by 182 days was 6.4% in the treatment group and 9.8% in the control group (risk difference, -3.4%; 95% CI, -6.9% to 0.1%; P = .06). A post hoc analysis of the effect of treatment on gram-positive (risk difference, -3.7%; 95% CI, -6.7% to -0.8%; P = .02) and gram-negative-only (risk difference, 0.3%; 95% CI, -1.6% to 2.1%; P = .78) infections found that the effect of vancomycin powder was a result of its reduction in gram-positive infections.CONCLUSIONS AND RELEVANCE Among patients with operatively treated tibial articular fractures at a high risk of infection, intrawound vancomycin powder at the time of definitive fracture fixation reduced the risk of a gram-positive deep surgical site infection, consistent with the activity of vancomycin.
This study confirms that peripheral nerve surgery can be safely performed with a very low complication rate if patients are properly selected and the surgeon is appropriately trained. A classification system for complications after peripheral nerve surgery and the most common variables associated with failures and complications are presented.
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