Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068822
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2003-09-10
Brief Title:
Vertebroplasty for the Treatment of Fractures Due to Osteoporosis
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Investigational Vertebroplasty Efficacy and Safety Trial INVEST
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vertebroplasty is a procedure used to stabilize broken vertebrae the bones that form the spine This study will evaluate the effectiveness of vertebroplasty for the treatment of fractures due to osteoporosis
Detailed Description:
Spontaneous atraumatic compression fractures due to osteoporosis occur in more than 700000 patients per year Pain associated with these fractures may be excruciating but before the advent of percutaneous vertebroplasty treatment options were limited Analgesic medications bed rest and bracing have been the mainstays of treatment but each of these therapies has substantial limitations
Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures the practice of percutaneous vertebroplasty which involves injection of polymethylmethacrylate medical cement into the fractured vertebra has disseminated rapidly However evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled nonblinded small case studies Even though high rates of success are reported with up to 90 of patients achieving substantial pain relief these case studies have not accounted for numerous important potential biases including the natural tendency for compression fractures to heal spontaneously regression toward the mean wherein patients seek medical attention when pain is maximum and the placebo effect This study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures
Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure placebo control group Participants may have up to 2 spinal levels treated Participants will be enrolled in the study for 1 year and will have study visits at entry and Months 1 and 12 There will also be phone visits at Days 1 2 3 and 14 and Months 3 and 6 After Month 1 crossover from the placebo group to the vertebroplasty group will be allowed
Because of the dearth of viable treatment options for osteoporotic vertebral compression fractures the practice of percutaneous vertebroplasty which involves injection of polymethylmethacrylate medical cement into the fractured vertebra has disseminated rapidly However evidence for the efficacy of percutaneous vertebroplasty is currently limited to uncontrolled nonblinded small case studies Even though high rates of success are reported with up to 90 of patients achieving substantial pain relief these case studies have not accounted for numerous important potential biases including the natural tendency for compression fractures to heal spontaneously regression toward the mean wherein patients seek medical attention when pain is maximum and the placebo effect This study will examine the clinical efficacy of percutaneous vertebroplasty for treatment of painful osteoporotic vertebral compression fractures
Participants in this study will be randomly assigned to receive either percutaneous vertebroplasty or a sham procedure placebo control group Participants may have up to 2 spinal levels treated Participants will be enrolled in the study for 1 year and will have study visits at entry and Months 1 and 12 There will also be phone visits at Days 1 2 3 and 14 and Months 3 and 6 After Month 1 crossover from the placebo group to the vertebroplasty group will be allowed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UL1RR025014 | NIH | None | httpsreporternihgovquickSearchUL1RR025014 |
| R01AR049373 | NIH | None | None |
| NIAMS-096 | None | None | None |