Osteoporotic Vertebral Compression Fractures
Conditions
Brief summary
Randomized trial comparing cost effectiveness and efficacy of kyphoplasty vs vertebroplasty for the treatment of painful, osteoporotic vertebral compression fractures.
Interventions
PROCEDUREKyphoplasty
kyphoplasty
Sponsors
Cardinal Health
ArthroCare Corporation
Cook Group Incorporated
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* \> or = 50 years of age * Compression fracture (T4-L5)within previous 12 mo. * Pain from compression fracture * No malignant tumor * No back surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Back specific functional status(Roland) | 12 mo |
| Pain | 12 mo |
Secondary
| Measure | Time frame |
|---|---|
| Health status outcome measure(SF-36) | 12 mo |
Countries
United States
Outcome results
None listed