Acute Osteoporotic Spinal Fractures Clinical Trial
Official title:
Investigational Percutaneous Vertebroplasty Efficacy and Safety Trial
| Verified date | September 2014 |
| Source | Jinan Military General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Enrolling by invitation |
| Enrollment | 140 |
| Est. completion date | December 2014 |
| Est. primary completion date | October 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
Inclusion Criteria: - 50 Years and older - have a confirmed diagnosis of osteoporosis or osteopenia. - acute, painful OVCFs from T4-L5 - clinical onset < 6 weeks - vertebral compression fracture on spine radiograph (minimum 15% height loss) - Visual Analogue Scale [VAS] score = 4 for pain Exclusion Criteria: - severe cardio-pulmonary condition - untreatable coagulopathy - active local or systemic infection - current malignancy, or radicular or caudal compression syndrome |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | The Jinan Military General Hospital | Jinan | Shandong |
| Lead Sponsor | Collaborator |
|---|---|
| Jinan Military General Hospital | Beijing Friendship Hospital, China Medical University, China, Shanghai 10th People's Hospital, Shanghai 6th People's Hospital, The Second Affiliated Hospital of Chongqing Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | VAS score | Pain assessment is based on the VAS scale, a scale from 0 (no pain) to 10 (worst pain ever), for which a decrease of 3.0 or more points from baseline is considered to be clinically significant pain relief. | at 1 month | No |
| Secondary | QUALEFFO total score | QUALEFFO total score is measured with the Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO). This questionnaire consists of 41 items and includes five domains: pain, physical function, social function, general health perception, and mental function. | at baseline, 1 week, 1 month, 3 months, 6 months, and 12 months after the treatment. | No |
| Secondary | ED-5Q score | EQ-5D is a standardized instrument utilized as a measure of health-related quality of life outcomes. Furthermore, EQ-5D is one of a few measures recommended for use in cost-effectiveness analyses by the Washington Panel on Cost Effectiveness in Health & Medicine as well as in National guidelines in economic evaluation. | at baseline, 1-week, and 1-, 3-, 6-, and 12- month | No |
| Secondary | RMD score | The RMD questionnaire is a disability questionnaire that measures the functional status of patients with back pain. RMD scores range from 0 to 24, with higher numbers indicating worse physical functioning. | at baseline, 1-week, and 1-, 3-, 6-, and 12- month | No |
| Secondary | New vertebral fractures | New vertebral fractures are defined as a decrease (compared with baseline radiographs) of 20% or more, and at least 4 mm, in any of the three vertebral heights (anterior, middle, or posterior) on follow-up. | at baseline, 1 month, 3 months, and 1 year. | Yes |
| Secondary | Total medical costs | This study will calculate total medical costs through summarizing all costs of drugs,family doctor,physiotherapist, hospital stay, and outpatient visits, etc. | at 1-month, 12-month | No |