Robert Zura1, Zekun Jack Xu, Gregory J Della Rocca, Samir Mehta, R Grant Steen. 1. *Department of Orthopaedic Surgery, Louisiana State University Medical Center, New Orleans, LA; †Department of Statistics, North Carolina State University, Raleigh, NC; ‡Department of Orthopaedic Surgery, Duke University, Durham, NC; and §Department of Orthopaedic Surgery, University of Pennsylvania, Philadelphia, PA.
Abstract
OBJECTIVE: The clinical value of low-intensity pulsed ultrasound (LIPUS) for fresh fracture is known. Yet, in the absence of a definition of what "fresh" is, payers have adopted study inclusion criteria drawn from randomized clinical trials as de facto definitions of which patients should be treated, with "fresh" defined as <1 week old. Patients with fracture may thus be ineligible for LIPUS treatment after week 1, which potentially denies access to patients who could benefit from LIPUS. We seek to characterize the inflection point at which heal rate declines. DESIGN: Prospective cohort. SETTING: Food and Drug Administration-mandated nationwide postmarketing surveillance registry. PATIENTS: Observational cohort of 5983 registry enrollees. INTERVENTION: LIPUS, 20 min/d. MAIN OUTCOME MEASURE: Fracture heal rate. Logistic regression was used to model the odds ratio of nonunion from week 1 to week 12. Covariates in the model included age, gender, body mass index, open fracture, and smoking. RESULTS: We estimated the time point at which a fracture responds to LIPUS as well as during the first week after fracture. There was significant bone-to-bone variation; metatarsal was "fresh" until week 7, ankle until week 9, humerus until week 10, and femur and radius until week 12. Healing was significantly impacted by patient age, body mass index, and open fracture (all, P ≤ 0.02). CONCLUSIONS: Our results suggest that fractures of the metatarsal, femur, humerus, ankle, and radius respond to LIPUS treatment, as if they were still fresh at least 6 weeks longer than the eligibility allowed under current coverage policies. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
OBJECTIVE: The clinical value of low-intensity pulsed ultrasound (LIPUS) for fresh fracture is known. Yet, in the absence of a definition of what "fresh" is, payers have adopted study inclusion criteria drawn from randomized clinical trials as de facto definitions of which patients should be treated, with "fresh" defined as <1 week old. Patients with fracture may thus be ineligible for LIPUS treatment after week 1, which potentially denies access to patients who could benefit from LIPUS. We seek to characterize the inflection point at which heal rate declines. DESIGN: Prospective cohort. SETTING: Food and Drug Administration-mandated nationwide postmarketing surveillance registry. PATIENTS: Observational cohort of 5983 registry enrollees. INTERVENTION: LIPUS, 20 min/d. MAIN OUTCOME MEASURE: Fracture heal rate. Logistic regression was used to model the odds ratio of nonunion from week 1 to week 12. Covariates in the model included age, gender, body mass index, open fracture, and smoking. RESULTS: We estimated the time point at which a fracture responds to LIPUS as well as during the first week after fracture. There was significant bone-to-bone variation; metatarsal was "fresh" until week 7, ankle until week 9, humerus until week 10, and femur and radius until week 12. Healing was significantly impacted by patient age, body mass index, and open fracture (all, P ≤ 0.02). CONCLUSIONS: Our results suggest that fractures of the metatarsal, femur, humerus, ankle, and radius respond to LIPUS treatment, as if they were still fresh at least 6 weeks longer than the eligibility allowed under current coverage policies. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.