FREE Study - Fracture Reduction Evaluation
This study has been completed.
Medtronic Spine LLC
Information provided by (Responsible Party):
Medtronic Spine LLC
First received: September 13, 2005
Last updated: April 18, 2012
Last verified: January 2012
The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral body compression fractures.
Device: Balloon Kyphoplasty
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||An International Multicentric, Multidisciplinary Prospective and Randomized Study to Compare Minimally Invasive Reduction and Fixation Using the KyphX System and Radiopaque PMMA Cement to Medical Therapy Alone for the Treatment of Painful, Acute Osteopenic Vertebral Body Compression Fractures|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Medtronic Spine LLC:
Primary Outcome Measures:
- The primary objective of this study is to compare the effectiveness of standard medical therapy alone to kyphoplasty using the KyphX system for the treatment of acute vertebral compression fractures (VCFs).
- Safety will be compared between the study groups throughout the study with focus on clinically meaningful events and subsequent VCFs including the "treated" vertebrae.
- The primary study endpoint is the change in quality of life as measured by the Physical Component Summary (PCS) scale of the 36-Item Short Form (SF-36) as measured at the one-month follow-up visit.
Secondary Outcome Measures:
- The secondary study endpoints are: EuroQol self-report (EQ-5D) questionnaire and SF-36 scores at 1, 3, 6, 12 and 24 months
- procedural safety (peri-operative clinical events)
- function as measured by objective functionality tests-reaching, "get up and go" and by the subjective Roland Morris disability questionnaire at 1, 3, 6, 12 and 24 months
- pain using a 10-point visual analogue scale (VAS) at 5-10 days (post enrollment for the control group and post kyphoplasty for the kyphoplasty group)
- changes in spinal deformity as measured radiographically at baseline, 3, 12 and 24 months.
- Maintenance of vertebral body height will be assessed from lateral spine x-rays obtained in Kyphoplasty treated subjects only at baseline and at 3, 12, and 24 month visits.
- patient satisfaction at 1, 3, 6, 12, 24 months
- outcome (nursing home, back to status prior to fracture) at 1, 3, 6, 12, 24 months
- economic aspects (including hospital days, disabilities, etc.) at 1, 3, 6, 12, 24 months
- the cost-effectiveness of kyphoplasty expressed in incremental cost/quality adjusted life year gained at different time points (1 year and 2 years)
- rate of incident fractures at 3, 12 and 24 months (frequency, timing and location)
- Each endpoint will be compared between the 2 groups and for its evolution over time.
|Study Start Date:||February 2003|
|Study Completion Date:||December 2007|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
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