Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

Study Overview
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Brief Summary
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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.

Official Title
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Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases

Conditions
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Metastasis

Intervention / Treatment
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* Device: Conventional Percutaneous Vertebroplasty
* Device: Percutaneous Vertebroplasty with Rotary Cutter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Imaging-proven and pathology-proven metastases Intractable pain with neurologic dysfunction Exclusion Criteria: 1. Poor general condition without tolerance of surgery
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Percutaneous Vertebroplasty<br>The cement is injected after the successful puncture. | Device: Conventional Percutaneous Vertebroplasty<br>* The cement is injected into the bone metastases directly.<br>|
| Experimental: Percutaneous Vertebroplasty with Rotary Cutter<br>The rotary cutter is applied to destroy the metastatic lesion before coment injection. | Device: Percutaneous Vertebroplasty with Rotary Cutter<br>* The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |