A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures
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|ClinicalTrials.gov Identifier: NCT01482793|
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : July 13, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Vertebral Compression Fractures Osteoporotic Vertebral Compression Fractures Acute Vertebral Fractures||Procedure: Vertebroplasty||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Controlled Trial of Vertebroplasty for Acute Painful Osteoporotic Fractures.|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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.
- Patient rated pain intensity [ Time Frame: two weeks ]
- Functional Disability [ Time Frame: two weeks ]Functional Disability (Roland Morris disability score) will be measured at 3 days, 7 days, 1 month, 3 and 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01482793
|Australia, New South Wales|
|Optimus Clinical Research|
|Sydney, New South Wales, Australia, 2217|
|Principal Investigator:||William Clark||St George Private Hospital|