Status:
COMPLETED
A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures
Lead Sponsor:
Optimus Clinical Research
Collaborating Sponsors:
C. R. Bard
Conditions:
Vertebral Compression Fractures
Osteoporotic Vertebral Compression Fractures
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
The objective of this study is to gather data regarding the efficacy, safety and cost-effectiveness of percutaneous vertebroplasty in the acute fracture group with fractures less than 6 weeks old. The...
Detailed Description
The study will be a two arm randomised, blind placebo controlled trial of vertebroplasty for acute (\< 6 weeks) osteoporotic vertebral compression fractures. Patients with substantial pain or immobili...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01482793
Start Date
November 1 2011
End Date
May 1 2015
Last Update
July 13 2015
Active Locations (1)
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1
Optimus Clinical Research
Sydney, New South Wales, Australia, 2217