Abstract
BackgroundThere are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1 year. The treatment of osteoporotic fractures is a major challenge as bone quality is poor, and healing is expected to delay due to the impaired healing properties with respect to bone formation, angiogenesis, and mineralization. Enhancement of osteoporotic fracture healing and function is therefore critical as a major goal in modern fracture management. Previous pre-clinical studies have shown that low-magnitude high-frequency vibration (LMHFV) accelerates osteoporotic fracture healing. The objective of this study is to investigate the effect of LMHFV on accelerating trochanteric hip fracture healing and functional recovery.MethodsThis is a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effect of LMHFV in accelerating trochanteric hip fracture healing. All fractures undergo cephalomedullary nail fixation. The primary outcome of this study is time to fracture healing by X-ray. Computed tomography (CT) and dual-energy X-ray absorptiometry (DXA) will also be performed. Blood circulation at the fracture site will be assessed by dynamic perfusion magnetic resonance (MR). Clinical results include functional recovery by muscle strength, timed up and go test (TUG), quality of life questionnaire (SF-36), balancing, falls, and mortality.DiscussionPrevious animal studies have demonstrated LMHFV to improve both normal and osteoporotic fracture healing by accelerating callus formation and mineralization. The mechanical stimulation stimulates angiogenesis by significantly enhancing vascular volume and blood flow velocity. This is the first study to translate LMHFV to enhancing hip fracture healing clinically. Positive results would provide a huge impact in the recovery of hip fracture patients and save healthcare costs.Trial registrationClinicaltrials.gov NCT04063891. Registered on August 21, 2019
Highlights
There are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1 year
The leading cause is due to osteoporosis and the lifetime fracture risk of osteoporotic patients reaches as high as 40% [2]
Further investigating into the molecular pathways, we have shown low-magnitude high-frequency vibration (LMHFV) to enhance healing from the early inflammation stage to the late phases of remodeling [7, 10,11,12,13]
Summary
There are more than 300,000 hip fractures yearly in the USA with mortality rates of 20% within 1 year. Previous pre-clinical studies have shown that low-magnitude high-frequency vibration (LMHFV) accelerates osteoporotic fracture healing. The objective of this study is to investigate the effect of LMHFV on accelerating trochanteric hip fracture healing and functional recovery. There are approximately 2.5 million osteoporotic fractures each year in the United States (US), with costs estimated at 15 billion USD in 2010 [3]. 300,000 hip fractures occur yearly in the US with mortality rates of 20% within 1 year [4]. In the United Kingdom (UK), approximately 80,000 hip fractures are treated yearly with direct costs of 2 billion pounds and mortality of 30% at 1 year [5]. The World Health Organization (WHO) predicts that the aging population will continue to rise over the 25 years, and the socioeconomic burden is expected to grow rapidly
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