A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures
Recruitment status was Recruiting
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 AVAMAX vertebroplasty kits (Care Fusion) will be used for all vertebroplasties.
The primary effectiveness analysis will be based on the number of patients whose numeric rating pain score drops from above 7 out of 10 at baseline to below 4 out of 10 at two weeks post-intervention. Our hypothesis is that the vertebroplasty group will have a significantly larger proportion of patients achieving pain reduction than the control group. A secondary analysis will compare the change in mean pain scores and specific activity related pain scores between the two groups at 3 days, 14 days and at 1, 3 and 6 months. Another secondary effectiveness analysis will include the mean change in the back-pain specific limitation in function as quantified by the Roland Scale at these same data collection time points.
Vertebral Compression Fractures
Osteoporotic Vertebral Compression Fractures
Acute Vertebral Fractures
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.|
- Patient rated pain intensity [ Time Frame: two weeks ] [ Designated as safety issue: No ]
- Functional Disability [ Time Frame: two weeks ] [ Designated as safety issue: No ]Functional Disability (Roland Morris disability score) will be measured at 3 days, 7 days, 1 month, 3 and 6 months.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Active Comparator: AVAMAX
Avamax vertebroplasty kits provided by Care Fusion
AVAmax radiopaque bone cement is injected into the vertebral body using a 13 G or 11 G vertebroplasty needle.
No Intervention: Simulated injection procedure
Patient will be unaware as to whether the control procedure or vertebroplasty had been performed since full sterile preparation, sedation and simulated injection procedure will be used.
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|Australia, New South Wales|
|Optimus Clinical Research||Recruiting|
|Sydney, New South Wales, Australia, 2217|
|Contact: Wendy Gellatley 61 2 9587 0238 email@example.com|
|Principal Investigator: Paul Bird|
|Principal Investigator:||William Clark||St George Private Hospital|