Spinal Fractures
Conditions
Keywords
Spinal Fractures/surgery, Vertebroplasty, Quality-Adjusted Life Years
Brief summary
Percutaneous vertebroplasty is now a common procedures of patients with acute osteoporotic vertebral compression fractures in medical units all over China, but the efficacy and essentiality of the surgery remain uncertain and is the subject of this study. This is a multiple center open-label randomised trial. Patients were randomly allocated to percutaneous vertebroplasty or conservative treatment. Because of the procedure , neither patients nor investigators were blinded. The primary outcome was pain relief at 1 month and 1 year.
Detailed description
This study will use a randomised controlled trial to access the efficacy and essentiality of the surgery for vertebral compression fractures. Patients aged 50 years or older, had vertebral compression fractures on spine radiograph (minimum 15% height loss) will be invited to take part. Patients will be randomised into 2 arms with average amount. The participants in the intervention arm will have percutaneous vertebroplasty ; those randomised to the control arm will receive current standard conservative treatment methods. Patients were clinically assessed at baseline (the day of surgery or treatment), and at 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year afterwards. The primary outcome will be the pain release , categorised according to WHO classification.
Interventions
PROCEDUREpercutaneous vertebroplasty
Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
PROCEDUREconservative treatment
complete on bed with prevention of complications
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* vertebral compression fracture on spine radiograph (minimum 15% height loss) * level of fracture at Th5 or lower; back pain for 6 weeks or less * focal tenderness at fracture level on physical examination * bone oedema of vertebral fracture on MRI * decreased bone density (T scores ≤-1)
Exclusion criteria
* severe cardiopulmonary comorbidity * suspected underlying malignant disease * radicular syndrome * spinal-cord compression syndrome * contraindication for radiography exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of pain relief | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year | World Health Organization pain classification |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) |
Contacts
Primary Contactchen guo
Outcome results
None listed