Secondary outcomes
nonunion, fracture, infections, necrotic, infection, Nonunion, fracture-related, fractures
INFECTION, SECONDARY, INFECTIONS, NECROTIC
The following are the secondary outcomes:Compare the rates of nonunion, a binary variable between the two treatment groups at 12 months after the initial treatment. Nonunion is defined as follows:Any unplanned reoperation for the promotion of bone healingmRUST ≤ 10 AND either FIX-IT score ≤ 11- at 12-month follow-up OR recommendation by treating surgeon for nonunion repair surgeryOccurrence of unplanned fracture-related reoperation, a binary variable, for infection, wound healing, or fracture union, excluding the removal of implants for prominence/irritation within 12 months of injury. This may include but is not limited to the following:Irrigation and debridement of surgical incisions or open fracture wounds due to infections or wound healing problemsRevision wound closure for dehiscenceSoft tissue coverage procedure for infected or necrotic woundFracture-delayed union or nonunion surgery (such as bone grafting or implant exchange)Reoperation for hardware or prosthesis failure due to infection or bone-healing problemsAmputation for infection, wound, or fracture healing problemCompare the two intervention groups for differences in radiographic healing using the modified RUST scores at each follow-up time point with appropriate radiographs (3, 6, 9, and 12 months)Compare the two intervention groups for differences in clinical union outcomes at each follow-up time point using the FIX-IT score (3, 6, 9, and 12 months)Compare the two intervention groups for differences in health-related quality of life at 12 months after fracture treatment using the EuorQol EQ-5D surveyCalculate the cost-effectiveness of the intervention through the quantification of the direct costs, indirect costs, and utility scores for open tibia fractures over the 12-month period following injury