Reactogenicity to COVID-19 vaccination in the United States of America.

PURPOSE: In the United States, Pfizer-BioNTech, Moderna, and Janssen's coronavirus disease 2019 (COVID-19) vaccines have been granted Emergency Use Authorization (EUA) with the Pfizer-BioNTech vaccine presently approved by the US Food and Drug Administration. The purpose of this study is to analyze passive surveillance data on COVID-19 vaccine adverse reaction in the United States. MATERIALS AND METHODS: We analyzed passive surveillance data on COVID-19 vaccine adverse reactions which were retrieved from the Vaccine Adverse Event Reporting System database. Retrieved records on demographic information as well as the top 10 common vaccine adverse events were extracted and assessed from 200 of the most recently reported cases for the study analysis. RESULTS: Local and systemic adverse reactions were reported in the study. A significant difference (p<0.05) was recorded for the top 10 systemic reactions by age category (0.041) and by gender (0.002). Analysis of the top five systemic reactions, stratified by vaccine type yielded a significant difference (p<0.05) for chills (p=0.044), and when stratified by age group and type of vaccination received, it yielded a significant difference (p<0.05) for fatigue (p=0.023). Overall, Pfizer had 182 persons (91.0%) reporting adverse events, Moderna with 13 (6.5%), and Janssen with 5 (2.5%). CONCLUSION: Mild side effects were reported following vaccination with the EUA COVID-19 vaccines in the United States. Thus, continuous monitoring and reporting of all adverse events are recommended to ensure the safety of vaccination.

Lateral Locking Plate Fixation of Simple Weber B Fibula Fractures Without a Lag Screw Yields Excellent Radiographic Results.

BACKGROUND: The most common first-line fixation technique for simple Weber B fibula fractures is a lag screw with lateral neutralization plate. The most common surgical technique for unstable Weber B fibula fracture is one-third semi-tubular plate and cortical screws, implemented with lag screw when appropriate. However, the lag technique can be technically challenging in osteoporotic bone or within fibulas of smaller diameter, and in some cases can result in fragmentation at the fracture site, malreduction, or peroneal irritation. The purpose of this study is to examine an alternative first-line method for routine treatment of simple Weber B fibula fractures. METHODS: Fifty-two consecutive patients undergoing open reduction internal fixation (ORIF) of a Weber B fibula fracture by a single surgeon were included in this retrospective study. After reduction, a lateral locking plate was applied with cortical screws proximally and locking screws distally. No screw crossed the fracture in any case. Per published precedent, nonunion was defined as either a gap of >3 mm between fracture surfaces >6 months postoperatively or a fracture line >2 to 3 mm wide and sclerosing of the fracture surfaces. Similarly, malunion was defined as one or more of the following: talar tilt >2º, talar subluxation >2 mm, or tibiofibular clear space ≥5 mm. RESULTS: The mean (± standard deviation) age of the 52 included patients was 44.2 ± 16.2 years, the mean body mass index was 27.7 ± 6.6 kg/m2, and 63.5% of patients identified themselves as female sex. The mean follow-up was 6.2 (range: 1.5-15) months. In addition to undergoing fixation of the lateral malleolus, 21 patients also underwent fixation of the posterior malleolus, 27 underwent fixation of the medial malleolus, 29 underwent fixation across the syndesmosis, and 7 underwent repair of the deltoid. In all patients, bony anatomic union of the fibula and congruence of the mortise were achieved with no cases of malunion or nonunion. CONCLUSIONS: The Arbeitsgemeinschaft für Osteosynthesefragen (AO) fixation technique for simple Weber B fractures with a lag screw and lateral neutralization plating has provided good outcomes for decades. We present an alternative technique for ORIF of these fractures with a lateral locking plate and no lag screw. In our series, we evaluated radiographic union and alignment as our primary outcome measures and found no cases of nonunion or malunion. Prospective cohort testing of lateral locking plates versus traditional fixation in the context of patient-centered value is warranted.Level of Evidence: Level III.

Randomized Trial of Dilute Povidone-Iodine Soak and Scrub for Orthopaedic Foot and Ankle Surgery.

BACKGROUND: There is no consensus as to which skin antiseptic solution is most effective at reducing infection following orthopaedic foot and ankle surgery. The purpose of this study is to determine if the addition of a dilute povidone-iodine soak and scrub to a standard preparation with alcohol and chlorhexidine decreases positive bacterial culture rates from the hallux nailfold. METHODS: In this prospective, randomized controlled trial, 242 subjects undergoing orthopaedic foot and ankle surgery were randomized to one of 2 groups. The control group received our standard 2-step skin antiseptic preparation of an alcohol scrub (step 1) followed by chlorhexidine/alcohol paint (step 2). The intervention group received a 3-minute dilute povidone-iodine soak and scrub followed by that same standard 2-step skin preparation. Immediately before skin incision, culture swabs were taken from the hallux nailfold of both groups. RESULTS: Of the 257 subjects enrolled and randomized, 242 (94.2%) completed the study, satisfying the a priori sample size requirement of 242 subjects. There were no crossovers between groups. There were no differences in baseline characteristics between groups (P > .05 for each). There was no difference in bacterial growth rates between groups (26.8% growth in the intervention group vs 26.9% growth in the control group, P = .991). CONCLUSION: The hallux nailfold is one of the most difficult to sterilize areas prior to orthopaedic foot and ankle surgery. This randomized controlled trail found no benefit to adding a 3-minute dilute povidone-iodine soak and scrub to a standard skin preparation with alcohol and chlorohexidine. LEVEL OF EVIDENCE: Level I, randomized controlled trial.

New Persistent Opioid Use After Orthopaedic Foot and Ankle Surgery: A Study of 348 Patients.

INTRODUCTION: The opioid epidemic is a devastating public health issue to which orthopaedic surgery is inextricably linked. The purpose of this study was to identify risk factors for new persistent opioid use after orthopaedic foot and ankle surgery among patients who were opioid naive preoperatively. METHODS: Patients undergoing orthopaedic foot or ankle surgery at a single institution were identified. Our state's prescription monitoring program was used to track opioid prescriptions filled in the preoperative (6 months to 30 days before surgery), perioperative (30 days before to 14 days after), and postoperative (2 to 6 months after) periods. Patients filling a prescription during the preoperative period were excluded. Baseline characteristics, surgical characteristics, and perioperative morphine milligram equivalents were tested for association with new persistent use during the postoperative period. RESULTS: A total of 348 opioid-naive patients met the inclusion criteria. Overall, the rate of new persistent postoperative opioid use was 8.9%. Patients reporting recreational drug use had the highest risk, at 26.7% (relative risk [RR] = 3.3, 95% confidence interval, 1.3 to 8.2, P = 0.0141). In addition, patients who had perioperative opioid prescription >160 morphine milligram equivalents were at increased risk (RR = 2.2, 95% confidence interval, 1.1 to 4.5, P = 0.021). Other risk factors included age ≥40 years (RR = 2.2, P = 0.049) and consumption of ≥6 alcoholic beverages per week (RR = 2.1, P = 0.040). New persistent use was not associated with ankle/hindfoot surgery (versus midfoot/forefoot), bone surgery (versus soft-tissue), or chronic condition (versus acute; P > 0.05). CONCLUSION: The rate of new persistent postoperative opioid use after orthopaedic foot and ankle surgery is high, at 8.9%. Greater perioperative opioid prescription is a risk factor for new persistent use and is modifiable. Other risk factors include recreational drug use, greater alcohol use, and greater age. Orthopaedic foot and ankle surgeons should limit perioperative prescriptions and be cognizant of these other risk factors to limit the negative effects of opioid prescriptions on their patients and communities. LEVEL OF EVIDENCE: Level III.

Skin Preparation Techniques for Orthopedic Foot and Ankle Surgery: A Current Concepts Review.

Surgical site infection (SSI) following orthopedic foot and ankle surgery is associated with morbidity, mortality, and cost to the healthcare system. The local anatomy and physiology predispose patients undergoing procedures to elevated risk. In particular, sterilizing of the webspaces, nailfolds, and subungual areas presents challenges, and the preferred skin antisepsis technique for foot and ankle procedures has not yet been defined. Skin antiseptic solutions (SASs) consist of 3 main categories: alcohol, chlorhexidine, and iodine-based solutions. This review of the literature supports a combined chlorhexidine and alcohol preparation technique; however, there are a number of studies that suggest otherwise. In addition, there is variable evidence for the use of alternatives to the standard soft sponge application technique, including immersion, bristled brush, and cotton gauze application. These alternatives may have a particular advantage in the forefoot. Most studies to date use growth from skin swab cultures after skin preparation as the primary outcome. Higher-level studies with large subject populations and more meaningful clinical outcomes will be required to solidify guidelines for preoperative skin antisepsis prior to foot and ankle procedures.Level of Evidence: Level V, expert opinion.

Radiographic Impact of Lapidus, Proximal Lateral Closing Wedge Osteotomy, and Suture Button Procedures on First Ray Length and Dorsiflexion for Hallux Valgus.

BACKGROUND: Shortening and dorsiflexion of the first metatarsal are known potential side effects of metatarsal osteotomies for hallux valgus (HV) with the potential to cause transfer metatarsalgia. We compared the effect of the first tarsometatarsal joint arthrodesis (Lapidus procedure), proximal lateral closing wedge osteotomy (PLCWO), and intermetatarsal suture button fixation procedures on the length and dorsiflexion of the first ray. METHODS: We retrospectively evaluated 105 feet in 99 patients with 30 weeks of follow-up. The average age was 54 years. Seventy-four feet had a Lapidus procedure, 12 had a PLCWO, and 19 had intermetatarsal suture button fixation. Digital radiographic measurements were made for the pre- and postoperative hallux valgus angle (HVA) and intermetatarsal angle (IMA), absolute and relative shortening of the first ray, and dorsiflexion. RESULTS: Preoperative HVA and IMA did not differ between treatment groups (P > .05 for each). Similar corrections of HVA (30.5-13.5 degrees) were achieved between all groups (P > .05). The IMA was improved more in the Lapidus group (14.3-6.5 degrees) compared with the suture button fixation group (14.2-8.1 degrees) (P = .045). There were significant differences in the change in absolute first cuneiform-metatarsal length (FCML) between the Lapidus (-1.6 mm), PLCWO (-2.3 mm), and intermetatarsal suture button fixation (+1.9 mm) procedure (P = .004). There were also significant differences in relative first metatarsal shortening between the Lapidus (0.1 mm relative shortening), PLCWO (1.1 mm relative shortening), and intermetatarsal suture button fixation (1.3 mm lengthening) procedure (P < .001). The average dorsiflexion differed between the Lapidus (1.8 degrees) and suture button fixation (0.4 degrees) groups (P = .004). CONCLUSION: Intermetatarsal suture button fixation relatively lengthened the first ray, the Lapidus procedure maintained length, and the PLCWO relatively and absolutely shortened it. Dorsiflexion may be higher with the Lapidus and osteotomy procedures. LEVEL OF EVIDENCE: Level III, retrospective comparative series.

Talar Osteonecrosis After Subchondroplasty for Acute Lateral Ligament Injuries: Case Series.

Talar osteonecrosis is a well-described phenomenon following talar neck fracture, but is a rarely described complication after procedures about the foot and ankle. Here we describe the clinical course of 5 cases of talar osteonecrosis following injection of calcium phosphate into the talus (subchondroplasty) with or without acute lateral ligament repair after acute lateral ankle ligament injuries performed at an outside institution. Practitioners should be aware of this potentially devastating complication. Future research is indicated to determine the safety and efficacy of subchondroplasty for the talus. LEVEL OF EVIDENCE: Level V, case series.

Effect of Leg Length-Evening Device on Perceived Balance in Patients Wearing a Controlled Ankle Motion Boot.

BACKGROUND: Patients are often made weightbearing as tolerated (WBAT) in a controlled ankle motion (CAM) boot for the management of various foot and ankle conditions. The CAM boot causes a leg length discrepancy (LLD) between the booted (longer) and contralateral (shorter) lower extremities. This discrepancy can potentially cause balance problems, undue strain on joints, and discomfort in patients. We hypothesized that a leg length-evening orthotic placed on the plantar aspect of the contralateral shoe improves balance among patients who are WBAT in a CAM boot. METHODS: Patients made WBAT in a CAM boot were randomized to either the leg length-evening orthotic intervention group or to a control group in which patients wore a normal shoe of their choice. Patients were followed for 2 weeks and asked a series of questions pertaining to balance and pain experienced at their knees, hips, and back. Balance was the primary outcome and was scored from 0 (no difficulty with balance) to 10 (great difficulty with balance). Of 107 subjects enrolled and randomized, 95 (88.8%) completed the study, satisfying the a priori sample size requirement of 94 patients. There were no differences in baseline characteristics between groups (P > .05 for each). RESULTS: Intervention patients reported less difficulty with balance than control patients (intention-to-treat analysis: 2.0±1.5 vs 3.2±1.8, P = .001; as-treated analysis: 2.1±1.7 vs 3.0±1.7, P = .009). Intervention and control patients did not differ with respect to pain experienced at their knees, hips, or back, or in a composite total pain score (P > .05 for each). CONCLUSION: This multicenter randomized controlled trial found that adding a limb length-evening orthotic to the plantar aspect of the contralateral shoe in a patient that is WBAT in a CAM boot improved patient-reported self-assessment of balance. The trial was powered to identify a difference in the primary outcome measure of balance and may have been insufficiently powered to identify differences in knee, hip, back, or total pain. LEVEL OF EVIDENCE: Level II, prospective comparative study.

Impact of Coleman Block Test on Adult Hindfoot Alignment Assessed by Clinical Examination, Radiography, and Weight-Bearing Computed Tomography.

BACKGROUND: Cavovarus foot constitutes a complex 3-dimensional deformity. The Coleman block test has traditionally been used to distinguish between forefoot- and hindfoot-driven deformity. However, there has been no objective evaluation of the Coleman block test using radiographs or weightbearing computed tomography (WBCT). The purpose of this study was to compare hindfoot alignment in adult cavovarus feet with and without the Coleman block using clinical examination, radiography, and WBCT. METHODS: Six feet in 6 patients with a clinical diagnosis of cavovarus foot deformity were prospectively enrolled. All feet underwent clinical photography with the camera positioned at 0 degrees to the heel, hindfoot alignment view radiography with the beam positioned 20 degrees off the ground, and WBCT, both with and without the Coleman block in place. Clinical photos were characterized using the standing talocalcaneal angle (STCA), radiographs were characterized using the hindfoot alignment angle (HAA), and WBCTs were characterized using manual and automated hindfoot alignment angle (HAA) and foot and ankle offset (FAO). Using paired analyses, measurements taken with the Coleman block in place were compared to those taken without the Coleman block. Finally, the different methods of measuring hindfoot alignment were tested for correlation with each other. Mean age was 56 years (range 38-69). RESULTS: On clinical photography, the STCA decreased by 3.8 degrees with addition of the block (from 10.0±6.6 degrees varus without block to 6.2±7.1 degrees varus with block; P = .001). On radiograph, HAA decreased by 9.0 degrees with addition of the block (from 16.8±8.4 degrees varus without block to 7.5±6.3 degrees varus with block; P = .07). On WBCT, hindfoot alignment angle changed an average of 3.2 degrees (33.4 degrees varus without block, 30.2 degrees varus with block; P = .008). On WBCT, FAO decreased by 1.4% (from 11.3% varus without block to 10.1% varus with block; P = .003). Clinical examination and automated WBCT measurements were strongly correlated with each other. CONCLUSION: Clinical examination, radiograph, and WBCT demonstrated improvements in hindfoot varus using the Coleman block test in adults, but no patient demonstrated complete resolution of deformity regardless of the measurement modality. Clinical examination correlated strongly with automated WBCT measurements. LEVEL OF EVIDENCE: Level IV, retrospective case review.

The Influence of Preoperative Mental Health on PROMIS Physical Function Outcomes Following Minimally Invasive Transforaminal Lumbar Interbody Fusion.

STUDY DESIGN: Retrospective. OBJECTIVE: To demonstrate whether preoperative mental health status can be predictive of postoperative functional outcomes as measured by Patient-Reported Outcome Measurement Information System Physical Function (PROMIS PF) following minimally invasive transforaminal lumbar interbody fusion (MIS TLIF). SUMMARY OF BACKGROUND DATA: There is a paucity of scientific investigations into the association between preoperative mental health as evaluated by a validated questionnaire such as the Short Form-12 Mental Health Composite Score (SF-12 MCS) and postoperative outcomes following MIS TLIF. METHODS: Patients undergoing a primary MIS TLIF were retrospectively reviewed and stratified into cohorts based on preoperative SF-12 MCS scores. The Physical Function scores of PROMIS, of which there are other domains including Pain Interference, Sexual Function, and Cognitive Function, were compared between the cohorts. In addition, the improvement in PROMIS scores based on preoperative SF-12 MCS scores following MIS TLIF was analyzed using multivariate linear regression. RESULTS: One hundred seventy-two patients were included: 85 patients (49.4%) had a preoperative SF-12 MCS score <50 and 87 (50.6%) had a preoperative SF-12 MCS score ≥50. Patients with poorer mental health demonstrated significantly worse PROMIS PF scores preoperatively (33.8 vs. 36.5, P < 0.001), as well as at all postoperative timepoints: 6-weeks (35.1 vs. 38.4, P < 0.001), 3-months (38.9 vs. 42.9, P < 0.001), 6-months (41.4 vs. 45.5, P < 0.001), and 1-year (42.4 vs. 47.6, P < 0.001). However, at the 1-year timepoint, patients with worse mental health reported experiencing significantly less improvement from baseline (postoperative change of 8.6 vs. 11.1, P = 0.002). CONCLUSION: Patients with worse preoperative mental health not only demonstrated worse preoperative PROMIS PF scores, but also continued to have significantly worse postoperative outcomes. However, the postoperative improvement experienced by patients was similar in the short-term following surgery regardless of preoperative mental health status. Patients with poor mental health experienced significantly less postoperative improvement only at the 1-year timepoint. LEVEL OF EVIDENCE: 3.