View clinical trials related to Fractures, Compression.
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Patients with osteoporotic vertebral body compression fractures will be randomly assigned to treatment with balloon kyphoplasty or vertebroplasty. Over 2 years of follow-up, back pain, back function, quality of life, adverse events, subsequent fractures and cumulative healthcare costs will be compared.
Doctors are studying an investigational treatment to be used during the vertebroplasty procedure when treating vertebral compression fractures (spine fractures) that may help to reduce pain and restore mobility. If one has experienced back pain for at least 4 weeks but not longer than 1 year, he/she may be eligible to participate. The purpose of this protocol is to describe the methods for the clinical evaluation of Cortoss for vertebroplasty in patients with painful osteoporotic compression fractures. Eligible patients with painful osteoporotic compression fractures of the spine are divided into two groups. Each enrolled patient will have the vertebroplasty procedure; however one group of patients will have the vertebroplasty procedure using polymethylmethacrylate [PMMA] (a Food and Drug Administration [FDA]-approved bone cement) and the other group of patients will have the vertebroplasty procedure using a relatively new (investigational) biomaterial called Cortoss.
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
The etiology and pathogenesis of osteoporosis has been extensively discussed. The relationship between bone blood circulation and the formation of bony trabeculae has been less understood. There is plenty of indirect evidence highly suggestive of the correlation between these two factors, such as: the number of blood vessels in the per unit area of the bone marrow was decreased in the osteoporotic bone, indicating the possible role of a microvascular defect in the pathogenesis of osteoporosis. Furthermore, the bone mineral density in severe arteriosclerotic patients was lower than in the less affected subjects. In a large scale epidemiologic study, diminished bone mineral density was strongly associated with increased deaths from stroke. Osteopenia was also associated with an increased risk of stroke. These reports highly suggest the effect of ischemia on bone metabolism and make the investigators more interested in further investigation. A dynamic contrast-enhanced magnetic resonance (MR) study was used recently in evaluating the blood perfusion of bone tumors. This method also has a strong correlation with the microsphere blood flow measurements. The investigator (T.F. Shih) used the dynamic MR in her recent two researches: 1. To differentiate benign versus malignant spinal compression fractures. 2. To evaluate the blood perfusion of non-fractured, normal-appearing vertebral bodies and find its significant correlation with aging and sex. The alterations of bone marrow perfusion are synchronous with the changes of bone mineral density. Thus, based on the investigators' previous research work, they propose to further explore the relationship between bone marrow perfusion and bone mineral density in different age groups.
Patients with vertebral compression fracture will be treated cement injection into the spine and monitored using standard evaluations.