A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures

Inclusion Criteria/Exclusion Criteria:

• Patient is greater than 60 years of age.
• Patient has pain which is not adequately controlled by oral analgesia or which has required hospitalisation and prevents early mobilisation
• Patient has pain from one or two compression fractures of the vertebrae in the areas T4 to L5 confirmed with a sagittal STIR (short tau inversion recovery) and sagittal T1 weighted MRI scan of the spine. Patients with three or more recent fractures are excluded.
• Clinical history verifies that patient's fracture occurred in the previous 6 weeks.
• Patient does not have a known coagulopathy. If on warfarin, the INR should be less than 2.5 within the last three days.
• Patient has no contraindications for conscious sedation.
• Patient reports pain during ambulation or movement from the compression fracture(s) of at least seven (7) out of ten (10) on a numerical pain scale.
• Patient has access to a telephone.
• Patient speaks English well enough to answer all health questions via telephone.
• Patient has a confirmed diagnosis of osteoporosis via a BMD within 6 months of baseline or a QCT at baseline.
• Patient does not have a history of debilitating chronic back pain which requires regular analgesia.
• Patients with chronic back pain who regularly use medication containing any narcotic for a period greater than 6 weeks, that is prior to the acute fracture.
• Patient does not have significant retropulsed fragment or spinal canal compromise of greater than 20% by retropulsed fragment.
• Patient has no mental incapacity or dementia that makes him/her unable to give informed consent.
• Patient has no history of vertebral osteomyelitis.
• Patient has vertebral body collapse not greater than 60% relative to closest intact vertebra.
• Patient has no pedicle fractures.
• Patient has no active local or systemic infection.
• Patient has not had surgery (within the last 60 days).
• Patient has no concomitant hip fracture.
• Patient has no malignant tumour deposit (multiple myeloma), tumour mass, or tumour extension into the epidural space at the level of the fracture to be treated on MRI.
• Patient does not have severely immunocompromised health status (including any patient who is HIV positive, currently on chemotherapy, taking high doses of long term corticosteroids - defined as a dose of prednisone exceeding 10mg for greater than 3 months in the last 12 months, has a hematologic malignancy, or a transplant recipient.)
• Patient able to attend face to face visits.