Intravaginal artesunate pessaries for treatment of cervical intraepithelial neoplasia 2/3 among HIV-positive and HIV-negative women in Kenya: Study protocol for a pilot trial.

Background: Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), which bear 90% of deaths. Current precancer treatments rely on healthcare workers who may be out of reach for many women. Development of a patient-controlled cervical precancer treatment can significantly improve access in remote areas and promote secondary prevention of cervical cancer. Methods: This is a phase I trial among 18 HIV-positive and HIV-negative women in Kenya, investigating use of artesunate vaginal pessaries as treatment for cervical precancer among women screening positive for cervical precancer who need excisional treatment. The primary objective will be the safety of self-administered artesunate pessaries. Participants will self-administer 200mg of artesunate vaginally daily for 5 days, followed by a drug-free week, repeated for a total of 4 cycles (artesunate self-administration on weeks 1, 3, 5, 7). The total study duration, including participant follow-up is 48 weeks. Safety and adherence will be assessed through review of symptom diaries and biweekly follow-ups during the treatment phase. Data analysis will include quantitative and qualitative methods. Figure 1 illustrates the study schema. Discussion: Considering the challenges associated with excisional treatments for cervical precancer in LMICs where access to care is limited, this study proposes an alternative approach using intravaginal Artesunate. This clinical trial will provide important safety and efficacy data on using artesunate as a topical therapy for both HIV-positive and HIV-negative women. Trial Registration: ClinicalTrials.gov identifier: NCT06165614.

Identification and Analysis of the Ankle Microbiome Using Next-Generation DNA Sequencing: An Observational Analysis.

INTRODUCTION: Next-generation DNA sequencing (NGS) technologies have increased the sensitivity for detecting the bacterial presence and have been used in other areas of orthopaedics to better understand the native microbiome of various joints. This study uses NGS to determine whether (1) a unique microbiome exists in human ankle tissues, (2) if components of the ankle microbiome affect patient outcomes, and (3) whether microbes found on the skin are a normal part of the ankle microbiome. METHODS: A prospective study recruited 32 patients undergoing total ankle arthroplasty (n = 23) or ankle arthrodesis (n = 9) via direct anterior approach between November 2020 and October 2021. During surgery, five layers of the ankle were swabbed: skin (n = 32), retinaculum (n = 31), tibialis anterior tendon (n = 31), joint capsule (n = 31), and distal tibia (n = 32). These swabs (N = 157) were sent to MicroGen Diagnostics (Lubbock) for NGS. Demographics, medical comorbidities, surgical indication, postoperative complications, readmission, and revision surgery rates were collected from patient records. RESULTS: The mean age was 60.7 (range, 19 to 85) years, and the mean follow-up duration was 10.2 (range, 4.8 to 20.6) months. Of 157 swabs sent for NGS, 19 (12.1%) indicated that bacteria were present (positive), whereas the remaining 138 (87.9%) had no bacteria present (negative). The most common organisms were Cutibacterium acnes in eight ankles (25.0%) and Staphylococcus epidermidis in two ankles (6.25%). Most bacteria were found in the retinaculum (29.6%). Complications, nonunions, infections, 90-day readmission, and revision surgery rates did not differ by NGS profile. DISCUSSION: This study found that C acnes and S epidermidis were the most common bacteria in the ankle microbiome, with C acnes being present in 25% of ankles. Complication rates did not differ between patients with or without positive bacterial DNA remnants. Thus, we concluded that a unique ankle microbiome is present in some patients, which is unique from that of the skin of the ankle. LEVEL OF EVIDENCE: Level II, Prospective cohort study.

Preoperative Opioid Therapy Correlated With Increased Rate of Complications in Foot and Ankle Surgery.

BACKGROUND: The purpose of this study is to determine whether patients with a history of preoperative opioid use will have an increased likelihood of postoperative opioid use and complications after undergoing forefoot, hindfoot, or ankle surgery. METHODS: A retrospective review was conducted on forefoot, hindfoot, and ankle surgeries between 2015 and 2020 with a single fellowship-trained orthopaedic foot and ankle surgeon at an academic medical center. A total of 326 patients (356 feet) were included with a mean follow-up up of 2.12 (range, 1.00-4.98) years. Data collected included demographics, medical comorbidities, treatment history, complications and reoperation rates, patient-reported outcome measures (eg, Foot and Ankle Outcome Score), and opioid exposure. RESULTS: There were significantly more complications among opioid exposed patients than opioid naïve ones (exposed = 29.41%, naïve = 9.62%; P = .044). Preoperative opioid exposure significantly correlated with postoperative opioid exposure (90-day: r = .903, p < .001; 180-day: r = .805, p < .001), and increased hospital length of stay (r = .263, p = .029). Furthermore, body mass index was a significant predictor of postoperative opioid exposure (90-day: r = .262, p = .013; 180-day: r = .217, p = .021), as was concomitant mental illness (90-day: r = .225, p = .035). CONCLUSION: Patients with preoperative opioid exposure have significantly more complications and increased postoperative opioid exposure after foot and ankle surgery. LEVELS OF EVIDENCE: Level III: Retrospective cohort study.

First metatarsophalangeal arthrodesis outcomes for hallux rigidus versus hallux valgus.

BACKGROUND: This study compared radiographic and functional patient outcomes of 1st MTP arthrodesis between hallux rigidus (HR) and hallux valgus (HV) cohorts. METHODS: A retrospective review was conducted at an academic medical center on patients who underwent 1st MTP arthrodesis during 2009-2021. In total, 136 patients (148 feet: HR=57, HV=47, combined=44) met the inclusion criteria of minimum three-month follow-up (mean=1.25 years, range=0.25-6.14 years). Data collection included patient-reported outcome measures (PROMs), radiographic markers, and complication and reoperation rates. RESULTS: PROMs improved overall, with HV patients significantly improving the least. The HR group had a significantly smaller improvement in HV angle (HR=-3.6, HV=-17, Combined=-15 p < .001), intermetatarsal angle (H=-0.16, HV=-2.8, Combined=-2.6 p < .001), and 1st-5th metatarsal width (HR=-0.98, HV=-4.6, Combined=-4.6, p < .001). Complication and reoperation rates did not differ by group. CONCLUSION: Outcomes of 1st MTP arthrodesis does not appear to differ between diagnostic indications of hallux rigidus, hallux valgus, or both. LEVEL OF EVIDENCE: Level III, Retrospective cohort study.

Tranexamic Acid Associated With Less Wound Complications in Ankle and Hindfoot Surgery: Level III, Retrospective Cohort Study.

INTRODUCTION: The purpose of this study was to determine whether total ankle arthroplasty (TAA) and ankle/hindfoot fusion patients receiving tranexamic acid (TXA) exhibit fewer wound complications. METHODS: A retrospective review was conducted of 212 patients (217 feet) undergoing TAA (n = 72), ankle (n = 36), tibiotalocalcaneal (n = 20), pantalar (n = 1), or hindfoot fusion (ie, subtalar = 47, double = 33, and triple = 8) between 2015 and 2020 by a fellowship-trained foot and ankle surgeon at an academic medical center. Demographics, medical history, complications, and union status were compared between TXA (n = 101) and non-TXA (n = 116) cohorts. The mean follow-up was 1.24 years (range, 0.25 to 4.68). RESULTS: The TXA group had significantly less postoperative infections (5.9% versus 15.5%, P = 0.025). Within a subgroup analysis of ankle/hindfoot fusions, the TXA group exhibited significantly more Charcot neuroarthropathy (20.7% versus 5.7%, P = 0.006) and shorter follow-up duration (0.96 versus 1.30 years, P = 0.030); however, TXA was associated with shorter time to fusion (146 versus 202 days, P = 0.049) and fewer revision surgeries (8.6% versus 21.8%, P = 0.036). Subgroup analysis excluding feet with Charcot also demonstrated less postoperative infections (4.5% versus 14.4%, P = 0.020). Subgroup analysis of TAAs showed fewer cases of superficial infections (2.3% versus 27.6%, P = 0.002) and delayed wound healing (25.6% versus 48.3%, P = 0.047) in the TXA cohort. DISCUSSION: TXA use in ankle/hindfoot surgery was correlated with a reduction in superficial infections and radiographic time to union. The use of TXA in TAA correlated with fewer superficial infections and cases of delayed wound healing. Thus, in addition to other areas of orthopaedics, TXA seems to be beneficial in hindfoot and ankle surgery. DATA AVAILABILITY AND TRIAL REGISTRATION NUMBERS: All data were obtained from our institution's medical records. This study is not associated with a clinical trial.

Pain Catastrophizing Scale Associated With Other Patient-Reported Outcome Measures in Plantar Fasciitis and Chronic Ankle Instability Patients.

BACKGROUND: The Pain Catastrophizing Scale (PCS) is a measure of how patients emotionally respond to pain. It is composed of 3 subscales-rumination, magnification, and helplessness-which address intrusive thoughts of pain, expectations of negative outcomes, and inability to cope with pain. Our purpose is to compare baseline PCS scores with other baseline patient-reported outcome measures (PROMs) in patients with plantar fasciitis (PF) or chronic ankle instability (CAI). METHODS: We retrospectively reviewed 201 patients who reported at least 1 pretreatment PCS subscore and were diagnosed with PF or CAI between 2015 and 2020 in a single fellowship-trained foot and ankle surgeon's clinic. Demographics, comorbidities, treatments, other baseline PROMs (i.e., visual analog scale [VAS], Pain Disability Index [PDI], 12-Item Short Form Survey [SF-12], 8-Item Somatic Symptom Scale [SSS-8]), and postoperative outcomes were recorded. RESULTS: The PCS total score and its subscores significantly correlated with the total score and/or subscores of each PROM. Higher PCS total score significantly correlated with worse VAS (P<.001), SF-12 mental (P=.007), PDI total (P<.001), and SSS-8 (P<.001) scores. Only the PCS magnification subscore was significantly greater among patients who did (n=41) undergo surgery (P=.043). Those who had previously undergone foot and/or ankle surgery had significantly higher PCS rumination (P=.012), magnification (P=.006), helplessness (P=.008), and total (P=.003) scores. Likewise, those with a history of substance abuse also had significantly higher PCS scores (P=.005; P=.003; P=.006; P=.003). CONCLUSION: The correlations between PCS scores and other baseline PROMs indicate that strong pain catastrophizers with PF or CAI may be at risk for poor treatment outcomes. PCS scores could be used to help with treatment for such high-risk patients.

The Influence of Pain and Resiliency on Foot and Ankle Surgery Outcomes.

Background: Resilience is the ability to recover after stressful events and has been shown to correlate with surgical outcomes. However, there has been minimal research on the impact of patient resiliency on foot and ankle surgical outcomes. This study aims to determine the predictive value of preoperative resiliency scores on surgical outcomes and investigate how this compares with the predictive value of pain scores. Methods: We conducted a retrospective review of adult patients who completed a preoperative Brief Resilience Scale (BRS) and underwent surgery between November 2019 and November 2020 with a fellowship-trained foot and ankle surgeon (N=184). Data included demographics, comorbidities, surgical details, complication and reoperation rates, pre- and postoperative opioid and benzodiazepine use, and additional patient-reported outcome measures (ie, visual analog scale [VAS], Pain Catastrophizing Scale [PCS], Pain Disability Index [PDI], Foot and Ankle Outcome Score [FAOS] pain subscale). Mean follow-up duration was 4.49 (range, 1.10-14.17) months. Results: BRS weakly correlated with decreased postoperative benzodiazepine use (P=.007). PCS magnification (P=.050) and helplessness (P=.047) subscales weakly correlated with increased follow-up duration. PDI total score and most subscores significantly correlated with an increase in at least 1 of the following: follow-up duration, or postoperative opioid or benzodiazepine use. Neither the VAS nor FAOS pain subscore correlated with any outcome. PDI total score was the strongest predictor of postoperative opioid (ß=0.334) and benzodiazepine (ß=0.315) use. Preoperative opioid users had significantly higher PDI total score (user=39.3, nonuser=24.9; P=.012) and subscores (ie, social activity, sexual behavior, self-care, life-support activities). Conclusion: BRS is an unreliable tool for predicting outcomes in foot and ankle surgery, as it only weakly correlated with decreased benzodiazepine use. Rather, given the PDI's strong associations with postoperative measures in this study, physicians should consider the value of preoperative PDI completion when predicting how foot and ankle surgery recipients will fare postoperatively. Level of Evidence: Level III, retrospective cohort study.

Trends in Orthopaedic Foot and Ankle Publications.

Background: Scientific publication and original articles remain the primary method of sharing scientific findings and advancing the knowledge base of that subject. Despite the value of these publications, little research has surveyed what topics are being published. This study aims to identify and characterize the most common topics in current foot and ankle literature. Methods: We reviewed all 1514 published articles in a 5.5-year period (January 2014-June 2019) in 2 foot and ankle-specific journals: Foot & Ankle International (FAI) and Foot and Ankle Surgery (FAS). The articles were sorted into different topic domains to identify the 3 most common categories of publication. The top 3 domains were further characterized by level of evidence (LOE) as well as citations. Results: The 3 most published topics in foot and ankle literature were hallux valgus (8.3%), total ankle arthroplasty (TAA) (8.3%), and ankle fracture (6.6%). These 3 subjects accounted for 351 articles (23.2%). Other common topics were patient-reported outcomes (5.0%), osteochondritis dissecans (3.9%), syndesmotic injury (3.8%), ankle instability (3.7%), hallux rigidus (3.0%), and anatomy (2.8%). The average LOE for articles on hallux valgus, TAA, and ankle fracture was 3.27 from FAI, and the average number of annual citations for a given article in both journals was 3.05. Based on our study, there is no correlation between LOE and number of overall citations, but there is a significant, negative linear correlation in ankle fracture data. We also found that articles on TAA had the highest impact factor and that articles from FAI were cited more often than articles from FAS. Conclusion: The 3 most published topics in foot and ankle literature comprise only 23.2% of all articles. This finding is indicative of the wide variety of cases performed by orthopaedic foot and ankle surgeons. High-quality data are still needed in all topics. Level of Evidence: Level III, retrospective cohort study.

No effect of preoperative ulceration on outcomes of tibiotalocalcaneal arthrodesis.

BACKGROUND: Tibiotalocalcaneal (TTC) arthrodesis is a commonly performed operation for complex hindfoot pathology, but the effect of preoperative ulceration on TTC outcomes has been debated. This study aims to examine infection rates in patients undergoing TTC arthrodesis with internal fixation with and without concomitant hindfoot ulceration. METHODS: We conducted a retrospective review of 31 patients who underwent a TTC arthrodesis between June 2016 and February 2021 with a fellowship-trained foot and ankle surgeon at an academic medical center. Nine (29.0%) patients had preoperative ulceration. Mean follow-up duration was 1.49 (range, 0.51-4.28) years. Other data collected included demographics, comorbidities, surgical approach, fixation method, and complication and reoperation rates. RESULTS: There was no difference in overall complication (ulcer [U]=66.7%, no ulcer [NU]=50.0%; p = .397), infection (U=33.3%, NU=31.8%; p = .935), or reoperation (U=55.6%, NU=27.3%; p = .135) rates between groups. CONCLUSIONS: TTC arthrodesis with internal fixation appears to be a reasonable treatment method for patients with a preoperative ulcer.