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Percutaneous vertebroplasty has been applied widely to treat bone metastases. The injected cement may strengthen the affected bone to prevent pathological fractures and relieve the pain. Moreover, the thermal reaction (70°C) due to polymerisation of cement also contributes to tumour destruction. The cement dose and diffusion pattern may be significant factors for the treatment efficacy, which can be affected by the inner pressure of the metastases. The investigators will apply a rotary cutter to destroy the structure of metastases to alleviate the pressure in the metastases. Then, more cement will be injected, which may effectively interdigitates with the surrounding bone and generate more thermo to kill the tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Percutaneous Vertebroplasty | Active Comparator | The cement is injected after the successful puncture. |
|
| Percutaneous Vertebroplasty with Rotary Cutter | Experimental | The rotary cutter is applied to destroy the metastatic lesion before coment injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional Percutaneous Vertebroplasty | Device | The cement is injected into the bone metastases directly. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Back pain: Visual analogue scales system | Measuring and comparing the pre- and post-operative back pain via Visual analogue scales (VAS) system with values from 0 to 10 (0 indicating no pain and 10 indicating the worst pain). Patients with a VAS score lower than 3 were classified as the effective group. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The patterns of cement opacification | The patterns of cement opacification were classified as solid patterns (cement forms a mass), trabecular patterns (cement spread along the fine bone trabeculae), and mixed patterns (cement forms a mass with spreading along the fine bone trabeculae). | during the procedure of vertebroplasty |
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Inclusion Criteria:
Exclusion Criteria:
1. Poor general condition without tolerance of surgery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Min Li, M.D. | Contact | 13953176057 | liminyingxiang@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 960 Hospital of PLA | Recruiting | Jinan | Shandong | 250031 | China |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Percutaneous Vertebroplasty with Rotary Cutter | Device | The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure. |
|
| Cement leakage |
The presence or absence of cement leakage is assessed in the groups with and without rotary cutter. |
| during the procedure of vertebroplasty |
| Cement volume | The injected cement volume were evaluated in the two groups. | during the procedure of vertebroplasty |