GO-Tibia: a masked, randomized control trial evaluating gentamicin versus saline in open tibia fractures.

BACKGROUND: The rate of open tibia fractures is rapidly increasing across the globe due to a recent rise in road traffic accidents, predominantly in low- and low-middle-income countries. These injuries are orthopedic emergencies associated with infection rates as high as 40% despite the use of systemic antibiotics and surgical debridement. The use of local antibiotics has shown some promise in reducing the burden of infection in these injuries due to increasing local tissue availability; however, no trial has yet been appropriately powered to evaluate for definitive evidence and the majority of current studies have taken place in a high-resource countries where resources and the bio-burden may be different. METHODS: This is a prospective randomized, masked, placebo-controlled superiority trial designed to evaluate the efficacy of locally administered gentamicin versus placebo in the prevention of fracture-related infection in adults (age > 18 years) with primarily closeable Gustillo-Anderson class I, II, and IIIA open tibia fractures. Eight hundred ninety patients will be randomized to receive an injection of either gentamicin (treatment group) or saline (control group) at the site of their primarily closed open fracture. The primary outcome will be the occurrence of a fracture-related infection occurring during the course of the 12-month follow-up. DISCUSSION: This study will definitively assess the effectiveness of local gentamicin for the prevention of fracture-related infections in adults with open tibia fractures in Tanzania. The results of this study have the potential to demonstrate a low-cost, widely available intervention for the reduction of infection in open tibia fractures. TRIAL REGISTRATION: Clinicaltrials.gov NCT05157126. Registered on December 14, 2021.

The Cost of Intramedullary Nailing for Femoral Shaft Fractures in Dar es Salaam, Tanzania.

BACKGROUND: Femoral shaft fractures are one of the most common injuries seen by surgeons in low- and middle-income countries (LMICs). Surgical repair in LMICs is often dismissed as not being cost-effective or unsafe, though little evidence exists to support this notion. Therefore, the goal of this study is to determine the cost of intramedullary nailing of femoral shaft fractures in Tanzania. METHODS: We used micro-costing methods to estimate the fixed and variable costs of intramedullary nailing of femoral shaft fractures. Variable costs assessed included medical personnel costs, ward personnel costs, implants, medications, and single-use supplies. Fixed costs included costs for surgical instruments and administrative and ancillary staff. RESULTS: 46 adult femoral shaft fracture patients admitted to Muhimbili Orthopaedic Institute between June and September 2014 were enrolled and treated with intramedullary fixation. The total cost per patient was $530.87 (SD $129.99). The mean variable cost per patient was $419.87 (SD $129.99), the largest portion coming from ward personnel $144.47 (SD $123.30), followed by implant $134.10 (SD $15.00) medical personnel $106.86 (SD $28.18), and medications/supplies $30.05 (SD $12.28). The mean fixed cost per patient was $111.00, consisting of support staff, $103.50, and surgical instruments, $7.50. CONCLUSIONS: Our study provides empirical information on the variable and fixed costs of intramedullary nailing of femoral shaft fractures in LMICs. Importantly, the lack of surgical capacity was the primary driver of the largest cost for this procedure, preoperative ward personnel time. Our results provide the cost data for a formal cost-effectiveness analysis on this intervention.