Factors Associated With Health-Related Quality of Life in Patients With Open Fractures.

OBJECTIVES: To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower health-related quality of life (HRQoL) at 12-month postfracture.

DESIGN: Prognostic study using data from a prospective randomized controlled trial.

SETTING: Thirty-one clinical centers in the United States, Canada, Australia, and India.

PATIENTS/PARTICIPANTS: One thousand four hundred twenty-seven patients with open fracture from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors.

INTERVENTION: Not applicable.

MAIN OUTCOME MEASUREMENT: Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 at 12-month postfracture.

RESULTS: One thousand four hundred twenty-seven patients were included in the SF-12 PCS and MCS linear regression models. Smoking, lower preinjury SF-12 PCS and MCS, and work-related injuries were significantly associated with lower SF-12 PCS and MCS at 12-month postfracture. A lower extremity fracture and a wound that was not closed at initial irrigation and debridement were significantly associated with lower 12-month SF-12 PCS but not MCS. Only the adjusted mean difference for lower extremity fractures approached the minimally important difference for the SF-12 PCS.

CONCLUSIONS: We identified a number of statistically significant baseline factors associated with lower HRQoL; however, only the presence of a lower extremity fracture approached clinical significance. More research is needed to quantify the impact of these factors on patients and to determine whether changes to modifiable factors at baseline will lead to clinically significant improvements in HRQoL after open fractures.

LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.