FREE Study - Fracture Reduction Evaluation
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|ClinicalTrials.gov Identifier: NCT00211211|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : December 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Osteopenia Osteoporosis Multiple Myeloma Bone Neoplasms||Device: Balloon Kyphoplasty||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||February 2003|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
- 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.
- 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.
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): NCT00211211
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||Prof. Johnell, MD||UMRA - Malmo, Sweden|