What this Trial Is About

Researchers are comparing two antibiotic methods during total ankle arthroplasty (TAA) to study their effects on antibiotic levels in bone, soft tissue, and the bloodstream. This Phase 4 trial aims primarily to see if vancomycin concentrations are similar in different tissues and systemically between patients receiving the two treatments. A secondary goal is to compare infection rates within 30 and 90 days after surgery between the standard intravenous (IV) vancomycin group and the intraosseous (IO) vancomycin group, hypothesizing no difference in infection complications. Participants will receive either the standard pre-operative IV vancomycin dose, given about one hour before surgery at approximately 15 mg/kg, or an IO injection of vancomycin (500 mg in 100-150 mL normal saline) administered directly into the medial malleolus during surgery after sterile preparation. Both groups receive antibiotics as part of their surgical care, but the method of vancomycin delivery differs to compare tissue and systemic levels. During the study, researchers will collect samples to measure vancomycin concentrations at multiple points: systemically before and after surgery, and locally in capsule or synovium tissue, distal tibia, and talar bone immediately after the procedure. They will also monitor for complications such as infections at 30 and 90 days post-operation. Participants must be followed through these time points to assess outcomes and safety over the study period.

Intraosseous vs. Intravenous Vancomycin Administration in Total Ankle Arthroplasty