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The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients with cancer.
1. STUDY OBJECTIVES AND ENDPOINTS
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, VCFs as compared to standard non-surgical therapy in patients with cancer.
1.2. Primary Endpoint
The primary endpoint of the study is the improvement in functional status, as measured by the Roland-Morris Disability Questionnaire (RDQ) at 1 month. The primary hypothesis of the study is that the mean improvement will be larger in subjects initially assigned to management with balloon kyphoplasty. Note that all subjects will undergo 12 months of follow-up after initial treatment assignment.
1.3. Secondary Endpoints
The following secondary endpoints will also be examined. Comparisons will be made at each follow-up visit.
- Rate of study treatment-related adverse events
- Change in neurological status
- Change in functional status as assessed with
- the Roland-Morris Disability Questionnaire
- the Karnofsky Performance Scale
- Change in quality of life as assessed by the SF-36v2™ Health Survey
- Change in back pain, as measured by a 10-point Numerical Rating Scale (NRS)
- Change in back-pain analgesics used
- Change in ambulation status
- Changes in activities of daily living
- Time to treatment failure
- Change in spinal deformity, defined as the degree of spine angulation as assessed by an independent radiologist at the core laboratory
- Rate of subsequent vertebral body fractures, as assessed by independent radiologists at the core lab
In each case, the study hypothesis is that treatment with balloon kyphoplasty will result in an improvement in clinical or radiographic outcomes compared to baseline and compared to non-surgical treatment, with a preservation of outcomes in long-term follow-up.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Balloon Kyphoplasty, Non Surgical Management
Valley Radiology Inc., UCSD
Medtronic Spine LLC
Published on BioPortfolio: 2014-07-24T14:27:09-0400
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