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
Background: Different surgical approaches for total hip arthroplasty (THA) exist, without predisposition when it comes to dislocation risk. The direct anterior approach (DAA) is thought to have reduced risk since soft tissue trauma is minimalized. Therefore, we assessed the dislocation risk for different surgical approaches, and the relative dislocation risk of DAA compared to other approaches. Methods: Six electronic databases were systematically searched for prospective studies reporting dislocation following THA. Proportion meta-analyses were performed to assess the dislocation rate for subgroups of the surgical approach. Meta-analysis for binary outcomes was performed to determine the relative risk of dislocation for the DAA compared to other approaches. Results: Eleven studies with 2025 patients were included (mean age 64.6 years, 44% male, mean follow-up 10.5 months), of which four studies were also used in the risk ratio meta-analysis. Overall dislocation rate was 0.79% (95% CI 0.37–1.69). Subgroup analyses showed that most dislocations occurred in the posterior approaches group (1.38%), however non-significant. Furthermore, the DAA emerged with a non-significant lower risk of dislocation (RR 0.37, 95% CI 0.05–2.46) compared to other surgical approaches. Conclusion: Current literature shows non-significant predisposition for a surgical approach to THA regarding dislocation risk. To what extent patient characteristics influence the risk of dislocation could not be determined. Future research should focus on this, as well as on the influence of a surgeon's experience with a specific approach.
