Relevant concomitant care permitted or prohibited during the trial {11d}
Fracture, fracture, traumatic, pain, fractures, Intramedullary nailing, intramedullary nailing
All patients will undergo standard of care treatment for open tibial shaft fractures at MOI regardless of their eligibility for enrollment in the study. This includes several perioperative co-interventions:Systemic antibiotic prophylaxis: All patients will receive a single dose of 1-g IV ceftriaxone as soon as possible after presentation to the hospital.Surgical debridement: All patients will undergo systematic debridement of the traumatic wound with the removal of any devitalized bone and soft tissue. Once the surgeon has deemed appropriate debridement has taken place the wound will be irrigated.Fracture stabilization: Fixation of the fracture will be at the discretion of the treating surgeon. It will be temporizing or definitive using either external fixation (EF) or intramedullary nailing (IMN). External fixation will be with a uniplanar external fixator consisting of a minimum of two Schanz pins proximal to the fracture and two Schanz pins distal to the fracture connected by a single stainless steel bar. Pin care protocol will consist of cleaning the pin sites with methyl alcohol twice daily for the duration of the external fixator placement. Intramedullary nailing will utilize the SIGN intramedullary nail system. An infrapatellar approach will be utilized with two proximal and two distal locking screws placed using an external jig. Intraoperative fluoroscopy will not be used routinely.Wound closure and wound care: The wound will be closed primarily when it is felt safe and feasible to do so by the operating surgeon. The wound will be checked at the 2-week visit, and if dry the dressing will be removed. If it is not, the patient will be instructed to perform additional wound care.Weight bearing protocol: All patients will be advised to be on toe-touch status for the first 6 weeks following surgery. Afterwards, the patient will be instructed to weight bear as permitted by pain.The study has no prohibited concomitant care. Patients may continue to use any additional medications so long as it is not placed locally around the wound site. If a medication is applied locally to the wound site, it will be recorded as a protocol violation.