Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Spinal Fractures, Osteoporosis
About this trial
This is an interventional treatment trial for Spinal Fractures focused on measuring Vertebroplasty, Crushed Vertebrae, Back Pain, Structurally Unstable Vertebrae, polymethylmethacrylate, INVEST, PMMA, RDQ
Eligibility Criteria
Inclusion Criteria: Confirmed osteoporosis or osteopenia by a referring physician and/or medical history and physical exam OR osteopenia on plain film Vertebral compression fracture in vertebrae T4 through L5, of less than 1 year old Pain not responsive to standard medical therapy Current rating for pain intensity of at least 3 on a scale of 0 to 10 Exclusion Criteria: Evidence or suspicion of malignant tumor or spinal canal compromise Concomitant hip fracture Local or systemic infection Uncorrectable bleeding diatheses Surgery within the previous 60 days Lack of access to telephone Inability to communicate in English Dementia Pregnancy Abnormal renal function or anticipated venography Conscious sedation is contraindicated for subject
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Vertebroplasty
Control Group
Participants will receive percutaneous vertebroplasty
Participants will receive sham vertebroplasty without PMMA