Abstract
BackgroundPatient age is one of many potential risk factors for fracture nonunion. Our hypothesis is that older patients (≥60) with fracture risk factors treated with low-intensity pulsed ultrasound (LIPUS) have similar heal rate (HR) to the population as a whole. We evaluate the impact of age in conjunction with other risk factors on HR in LIPUS-treated patients with fresh fracture (≤90 days old).MethodsThe Exogen Bone Healing System is a LIPUS device approved in 1994 to accelerate healing of fresh fracture. After approval, the FDA required a Post-Market Registry to assess performance. Patient data collected from October 1994 until October 1998 were individually reviewed and validated by a registered nurse. Four distinct data elements were required to report a patient: date fracture occurred; date treatment began; date treatment ended; and a dichotomous outcome of healed v. failed, by clinical and radiological criteria. Data were used to calculate two derived variables; days to treatment (DTT) and days on treatment (DOT). Every validated fresh fracture patient with DTT, DOT, and outcome is reported.ResultsThe validated registry had 5,765 patients with fresh fracture; 73% (N = 4,190) are reported, while 13% of patients were lost to follow-up, 11% withdrew or were non-compliant, and 3% died or are missing outcome. Among treatment-compliant patients, HR was 96.2%. Logistic estimates of the odds ratio for healing are equivalent for patients age 30 to 79 years and all age cohorts had a HR > 94%. Open fracture, current smoking, diabetes, vascular insufficiency, osteoporosis, cancer, rheumatoid arthritis, and prescription NSAIDs all reduced HR, but older patients (≥60) had similar HRs to the population as a whole. DTT was significantly shorter for patients who healed (p < 0.0001).ConclusionsComorbid conditions in conjunction with aging can reduce fracture HR. Patients with fracture who used LIPUS had a 96% HR, whereas the expected HR averages 93%. Time to treatment was significantly shorter among patients who healed (p < 0.0001), suggesting that it is beneficial to begin LIPUS treatment early. Older patients (≥60) with fracture risk factors treated with LIPUS exhibit similar heal rates to the population as a whole.
Highlights
Patient age is one of many potential risk factors for fracture nonunion
72.7% of all fresh fracture patients who received low-intensity pulsed ultrasound (LIPUS) treatment are reported (=4,190/5,765), while 12.8% of patients were lost to follow-up, 5.8% of patients were deemed non-compliant, 5.3% of patients withdrew from treatment, and 3.4% died or were missing an outcome
Logistic estimates of the odds ratio for healing are equivalent for patients age 30 to 79 years, and the heal rate (HR) for 298 LIPUS-treated patients age 70 to 79 years was nearly identical to the overall HR
Summary
Patient age is one of many potential risk factors for fracture nonunion. Our hypothesis is that older patients (≥60) with fracture risk factors treated with low-intensity pulsed ultrasound (LIPUS) have similar heal rate (HR) to the population as a whole. We evaluate the impact of age in conjunction with other risk factors on HR in LIPUS-treated patients with fresh fracture (≤90 days old). Risk factors for fracture nonunion include patient age and the medical comorbidities attendant to age, as well as characteristics of the fracture itself [1]. Obesity increases fracture risk even in young women [3]; yet body-mass index (BMI) tends to increase with age [4] and with a range of comorbid illnesses that increase with age, including diabetes, metabolic syndrome, insulin resistance, and inflammation [5].
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