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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| grade 1 | Experimental | percutaneous vertebroplasty |
|
| grade 2 | Active Comparator | conservative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| percutaneous vertebroplasty | Procedure | Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| change of pain relief | World Health Organization pain classification | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | Quality of Life Questionnaire of the European Foundation for Osteoporosis (QUALEFFO) | 1 day, 1 week, 1 month, 3 months, 6 months, and 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chen guo | Contact | 8618055644700 | fantasy_g@163.com |
| Name | Affiliation | Role |
|---|---|---|
| haiying liu | PekingUPH department of spinal surgery | Study Director |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| conservative treatment | Procedure | complete on bed with prevention of complications |
|