Acute Osteoporotic Spinal Fractures Clinical Trial
Official title:
Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
Percutaneous vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management has not been successful or for those who are at risk for developing complications due to long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP have been published with conflicting results. Two RCTs with a sham control intervention failed to show an advantage of vertebroplasty over placebo for participants with acute, subacute, and chronic fractures or severe pain. In the third RCT, PVP compared to optimal conservative treatment showed significant immediate postoperative pain relief in the vertebroplasty group, but not at 3 and 12 months. To examine these issues, this study is initiated to compare PVP with conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses concerns about the possibility that PVP increases the incidence of new compression fractures in adjacent vertebrae.
Osteoporotic vertebral fractures (OVCFs) are common in the elderly population, with an
estimated 1.4 million new fractures occurring every year worldwide. Patients may present
with pain and frequently require hospital admission for analgesia, bed rest, and physical
support (bracing). While their back pain may last for 6-12 weeks, complications such as
pneumonia, decubitus ulcers, venous thromboembolism, and even death may occur. Percutaneous
vertebroplasty (PVP) is now a therapeutic option for individuals for whom medical management
has not been successful or for those who are at risk for developing complications due to
long-term immobilization. Recently, three randomized controlled trials (RCT) concerning PVP
have been published with conflicting results. So this study is to compare PVP with
conservative therapy in patients with osteoporotic VCFs. Moreover, this study addresses
concerns about the possibility that PVP increases the incidence of new compression fractures
in adjacent vertebrae.
This study is a multicenter randomized controlled trial (RCT), Participants in this study
will be allocated randomly to PVP or conservative treatment.All Participants will be asked
to fill out standard questionnaires to provide clinical information at baseline (the day of
randomization), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after the
treatment. Cross-over will not be offered before 12 months after randomization. All standard
questionnaires (except the 1-day questionnaire) consist of the VAS score, Quality of Life
Questionnaire of the European Foundation for Osteoporosis (QUALEFFO), EQ-5D, and
Roland-Morris Disability (RMD) Questionnaire. Furthermore,additional questions about pain
treatment, hospital stay, outpatient visits,medical aids, and medical costs will be
completed with the help of a nurse practitioner.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment