Plasma and tissue concentrations of 2 g prophylactic cefazolin prior to lower extremity surgery.

Surgical site infections (SSIs) are among the most clinically relevant complications and the use of prophylactic cefazolin is common practice. However, the knowledge about the pharmacological aspects of prophylactic cefazolin in the lower extremities remains limited. In this prospective cohort, a sub-study of the WIFI-2 randomized controlled trial, adults between 18 and 75 years of age who were scheduled for implant removal below the level of the knee and randomized for cefazolin, was included. A maximum of two venous plasma, target-site plasma, and target-site tissue samples were taken during surgery. The primary outcomes were the cefazolin concentrations in venous plasma, target-site plasma, and target-site tissue. A total of 27 patients [median (interquartile range) age, 42 (29-59) years; 17 (63%) male] with 138 samples were included in the study. A minimum of 6 weeks follow-up was available for all patients. The mean (SD) venous plasma, target-site plasma, and target-site tissue concentrations were 36 (13) µg/mL, 29 (13) µg/mL, and 28 (13) µg/g, respectively, and the cefazolin concentrations between the different locations of surgery did not differ significantly in both target-site plasma and target-site tissue (P = 0.822 and P = 0.840). In conclusion, 2 g of prophylactic cefazolin demonstrates adequacy in maintaining coverage for a duration of at least 80 minutes of surgery below the level of the knee, significantly surpassing the MIC90 required to combat the most prevalent microorganisms. This study represents the first of its kind to assess cefazolin concentrations in the lower extremities by examining both plasma and tissue samples in this magnitude.

The minimal clinically important difference (MCID) of the Olerud Molander Ankle Score (OMAS) in patients with unstable ankle fracture.

INTRODUCTION: The Olerud Molander Ankle Score (OMAS) is a widely used validated Patient Reported Outcome Measure (PROM). For clinical research, it is important to determine the Minimal Clinically Important Difference (MCID). The objective of this study was to determine the MCID of the OMAS at several moments in the follow-up, in a cohort of patients that underwent open reduction and internal fixation of unstable ankle fractures with syndesmotic injury. MATERIALS AND METHODS: Data for this descriptive study were extracted from a prospective randomized controlled trial, the RODEO trial. The Dutch version of the OMAS was completed at 3, 6 and 12-month follow-up and estimated at baseline. The used anchor-based methods were: mean change and ROC curve. The distribution-based methods were: 0.5SD and minimal detectable change (MDC). RESULTS: This cohort included 148 patients. The mean OMAS score in the group with minimal improvement between 3 and 6 months was 15.0 (SD 17.5, 95%CI 9.4-20.6) and between 6 and 12 months 9.5 (SD 17.1, 95% CI 3.1-15.9). The ROC curve between 3 and 6 months resulted in a MCID of 12.5 (AUC 0.72) and between 6 and 12 months, the MCID was 7.5 (AUC 0.78). Using 0.5 SD, the MCID was 10.52 (SD 21.04) at 3 months, 11.37 (SD 22.73) at 6 months and 10.47 (SD 20.94) at 12 months. The MDC was 4.72 at 3 months, 5.20 at 6 months and 4.71 at 12 months. CONCLUSIONS: The calculated MCID in patients following surgery for unstable ankle fractures ranges from 10.5 to 15.0 at 3-6-month follow-up and from 7.5 to 11.4 at 6-12-month follow-up, depending on moment and method.

Open Ankle Arthrodesis: A Retrospective Analysis Comparing Different Fixation Methods.

A wide variation of surgical options, complications, and union rates are reported in the treatment of end-stage ankle arthritis. However, open ankle arthrodesis remains the golden standard for ankle arthritis. The purpose of this study was to evaluate the union rate and complication rate as well as identify potential risk factors for different methods of fixation in patients with end-stage ankle arthritis of different etiology. In total, 42 ankles of 41 patients with ankle osteoarthritis were included for this single-center retrospective study. The mean age was 50 years (range 22-75 years). Twenty patients were treated with screw-fixation, 14 with plate(s) and 8 with intramedullary nail. The results of this study showed an overall union rate of 97.6% (41 of the 42 operated ankles) and an overall complication rate of 21.4% (9 events). The mean follow-up time was 16 months (range 2.5-83.0 months). Complications consisted of 1 nonunion, 4 deep infections, 2 cases of wound dehiscence, 1 delayed union and 1 malalignment of the ankle joint. The plate-fixation group demonstrated significantly higher infections when compared with screw and intramedullary nail fixation (p = .017). There were no other significant variables for incidence of complications between patients in the uncomplicated and complicated group. This study achieved good clinical results for different methods of fixation in open ankle arthrodesis. In specific, the use of intramedullary nail provides excellent results for end-stage ankle arthritis with high union rate and a low complication rate.

Wound infection following implant removal of foot, ankle, lower leg or patella; a protocol for a multicenter randomized controlled trial investigating the (cost-)effectiveness of 2 g of prophylactic cefazolin compared to placebo (WIFI-2 trial).

BACKGROUND: Elective implant removal (IR) after fracture fixation is one of the most common procedures within (orthopedic) trauma surgery. The rate of surgical site infections (SSIs) in this procedure is quite high, especially below the level of the knee. Antibiotic prophylaxis is not routinely prescribed, even though it has proved to lower SSI rates in other (orthopedic) trauma surgical procedures. The primary objective is to study the effectiveness of a single intravenous dose of 2 g of cefazolin on SSIs after IR following fixation of foot, ankle and/or lower leg fractures. METHODS: This is a multicenter, double-blind placebo controlled trial with a superiority design, including adult patients undergoing elective implant removal after fixation of a fracture of foot, ankle, lower leg or patella. Exclusion criteria are: an active infection, current antibiotic treatment, or a medical condition contraindicating prophylaxis with cefazolin including allergy. Patients are randomized to receive a single preoperative intravenous dose of either 2 g of cefazolin or a placebo (NaCl). The primary analysis will be an intention-to-treat comparison of the proportion of patients with a SSI at 90 days after IR in both groups. DISCUSSION: If 2 g of prophylactic cefazolin proves to be both effective and cost-effective in preventing SSI, this would have implications for current guidelines. Combined with the high infection rate of IR which previous studies have shown, it would be sufficiently substantiated for guidelines to suggest protocolled use of prophylactic antibiotics in IR of foot, ankle, lower leg or patella. Trial registration Nederlands Trial Register (NTR): NL8284, registered on 9th of January 2020, https://www.trialregister.nl/trial/8284.

Measuring External Rotation of the Fibula and Fibular Length in Bilateral Computed Tomography Scans: How Reliable Is This Method?

OBJECTIVES: During ankle fracture surgery, goals include accurate reduction and fixation of the fibula regarding rotation and fibular length. Bilateral postoperative computed tomography (CT) can be performed to assess fibular rotation using the talar dome angle, and fibular length. The aim of this study was to compare side-to-side differences of the fibular rotation and fibular length using bilateral CT scans of uninjured ankles. DESIGN: Retrospective. SETTING: Single center, Level I Academic Trauma Center. PATIENT SELECTION CRITERIA: Patients with bilateral CT scans of uninjured ankles. OUTCOME MEASURES AND COMPARISONS: External rotation using the Nault talar dome method and fibular length using the coronal method of Prior et al. The average, difference, and ratio (injured side/healthy side) and interobserver variability were calculated. RESULTS: There were 83 patients included (166 ankles, mean age 47 years, 77.1% male). A random set of 66 ankles (33 CT scans) were used to measure interobserver variability. The mean degrees of external rotation ranged from 6.6 to 7.7, mean difference ranged from 1.4 to 3.4 degrees, mean ratio ranged from 1.1 to 1.5, and interobserver variability ranged from 0.27 to 0.65. For fibular length, the mean ranged from 24.6 to 25.8 mm, mean difference in fibular length ranged from 0.5 to 2.1 mm, mean ratio ranged from 1.0 to 1.1 mm, and interobserver variability ranged from 0.45 to 0.73. CONCLUSIONS: Using bilateral ankle CT scans, mean differences in fibular rotation using the Nault talar dome method were 1.4-3.4 degrees. The distal fibular length had a mean difference between both sides of 0.5-2.1 mm. Although the intraclass correlation's were low, the interleg differences between patients were small, making them useful for clinical practice. LEVEL OF EVIDENCE: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

Functional outcome of routine versus on-demand removal of the syndesmotic screw.

Aims: The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS). Methods: All patients included in the 'ROutine vs on DEmand removal Of the syndesmotic screw' (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups. Results: The median OMAS score was 85.0 for patients treated with RR, and 90.0 for patients treated with ODR (p = 0.384), indicating no significant difference between ODR and RR. The secondary outcome measures included the AOFAS (88.0 in the RR group and 90.0 for ODR; p = 0.722), FAOS (87.5 in the RR group and 92.9 for ODR; p = 0.399), and EQ-5D (0.87 in the RR group and 0.96 for ODR; p = 0.092). Conclusion: This study demonstrated no functional difference comparing ODR to RR in syndesmotic injuries at a four year follow-up period, which supports the results of the primary RODEO trial. ODR should be the standard practice after syndesmotic screw fixation.

Surgical Site Infections After Routine Syndesmotic Screw Removal: A Systematic Review.

OBJECTIVES: To investigate the incidence of surgical site infections (SSIs) after routine removal of syndesmotic screws (SSs) placed to stabilize syndesmotic injuries. DATA SOURCES: A systematic literature search was performed in the PubMed, Cochrane, and EMBASE databases for studies published online before February 2020, using the key words and synonyms of "syndesmotic screw" ("ankle fractures" or "syndesmotic injury") and "implant removal." STUDY SELECTION: Studies were eligible for inclusion when they described >10 adult patients undergoing elective/scheduled removal of the SS. DATA EXTRACTION: The 15 included articles were assessed for quality and risk of bias using the Newcastle-Ottawa Scale. Baseline characteristics of the studies, the study population, the intervention, the potential confounders, and the primary outcome (% of SSIs) were extracted using a customized extraction sheet. DATA SYNTHESIS: The primary outcome was presented as a proportion of included patients and as a weighted mean, using inverse variance, calculated in RStudio. Furthermore, potential confounders were identified. CONCLUSIONS: The percentage of SSIs ranged from 0% to 9.2%, with a weighted mean of 4%. The largest proportion of these infections were superficial (3%, 95% confidence interval: 2-5), compared with 2% deep infections (95% confidence interval: 1-4). These rates were comparable to those of other foot/ankle procedures indicating that the individual indication for SS removal (SSR) should be carefully considered. Future studies should focus on valid indications for SSR, the influence of prophylactic antibiotics on an SSI after SSR, and complications of retaining the SS to enable a fair benefits/risks comparison of routine versus on-demand removal of the SS. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.