Healthcare Resource Utilization and Costs among Patients with and without Infection after Intramedullary Nailing for A Tibial Shaft Fracture

Study type
Protocol
Date of Approval
Study reference ID
17_132
Lay Summary

Tibial shaft fractures are the most common long bone fracture of the lower limbs. Intramedullary nailing is the most frequent surgical treatment for tibial shaft fractures. In patients with tibial shaft fractures, infection is an important complication as about 15% of these fractures are open injuries. Such infections may lead to devastating consequences such as increase in length of hospital stay, readmissions, prolonged medication treatment and reoperations along with high use of medical resources and costs. However, the healthcare burden among patients developing an infection in tibial shaft fracture is not well documented. Consequently, this study seeks to understand the impact of infection after intramedullary nailing in patients with tibial shaft fractures on healthcare use and cost of care.

Technical Summary

The objective of this retrospective longitudinal cohort study is primarily designed to determine short (30-day, 90-day) and mid-term (one-year, two-year) healthcare resource utilization (HRU) and costs among patients with deep and superficial infections versus those without following intramedullary nailing for a tibial shaft fracture. Patients with tibial shaft fracture treated with intramedullary nailing between 2011 and 2016 will be selected. The main exposure variable will include deep infection versus superficial surgical site infection or no infection. Analyses will be both descriptive and comparative using multivariable models. The multivariable models will include generalized linear models (GLMs) based on the outcome variable of interest for HRU and costs and will adjust for patient characteristics.

Health Outcomes to be Measured

Short term (30-day, 90-day) and mid-term (one-year, two-year) healthcare costs among patients with deep infection and superficial infection versus patients without infection; Short term (30-day, 90-day) and mid-term (one-year, two-year) healthcare resource utilization (HRU) among patients with deep infection and superficial infection versus patients without infection

Collaborators

Abhishek Chitnis - Chief Investigator - Johnson & Johnson ( JnJ - USA )
Abhishek Chitnis - Corresponding Applicant - Johnson & Johnson ( JnJ - USA )
Chantal Holy - Collaborator - Johnson & Johnson ( JnJ - USA )
David Wei - Collaborator - Johnson & Johnson ( JnJ - USA )
Konstantina Paparouni - Collaborator - Synthes GmbH
Peter-Panagiotis Giannoudis - Collaborator - University of Leeds
Simone Wolf - Collaborator - Synthes GmbH
Thibaut Galvain - Collaborator - Johnson & Johnson Medical SAS

Linkages

HES Admitted Patient Care