WHEN IS A BONE FRACTURE NO LONGER "FRESH"?
Author(s)
Scott RA, Jones J, Steen RG
Bioventus LLC, Durham, NC, USA
Presentation Documents
OBJECTIVES: Robust literature demonstrates the clinical value of low-intensity pulsed ultrasound (LIPUS) in the treatment of fresh bone fractures. However, each published study used an arbitrary time post-fracture to define a “fresh fracture” for study inclusion. In the absence of an accepted clinical definition of fresh fracture, many third-party payers have adopted study inclusion criteria as de facto definitions of fresh fracture. Yet exclusion of older fractures may deny access to patients who could benefit from LIPUS. We pooled data from patients in a post-market LIPUS registry required by the Food & Drug Administration to analyze the inflection point at which fracture heal rates begin to decline. METHODS: Patients are evaluated if the following data are known: days to LIPUS treatment; days on LIPUS treatment; and outcome of treatment (Heal / Fail). We present data from 7,117 patients treated with LIPUS within 365 days of fracture. We plot (Heal rate) vs. (Days to LIPUS treatment), to determine the inflection point at which Heal rate begins to decline. RESULTS: Heal rate (Number of patients healed / Number of patients treated) did not differ significantly or clinically for at least 10 weeks following fracture. In 284 fracture patients who began LIPUS within 1 week of fracture, the heal rate was 97.2% (276 healed / 284 treated). In 246 patients who began LIPUS treatment 10 weeks after fracture, the heal rate was 97.6% (240 healed / 246 treated). There may be a decrease in heal rate after 10 weeks, but the heal rate for patients at week 12 was 95.6% (195 healed / 204 treated). CONCLUSIONS: Heal rate with LIPUS was ~97% for ≤10 weeks following fracture. Many patients who could benefit may be unnecessarily excluded from treatment by payer guidelines. We will evaluate heal rate bone-by-bone (tibia, femur, humerus, radius, metatarsal) using this method.
Conference/Value in Health Info
2015-11, ISPOR Europe 2015, Milan, Italy
Value in Health, Vol. 18, No. 7 (November 2015)
Code
PMD129
Topic
Health Policy & Regulatory, Health Service Delivery & Process of Care
Topic Subcategory
Pricing Policy & Schemes, Reimbursement & Access Policy, Treatment Patterns and Guidelines
Disease
Musculoskeletal Disorders