Metastasis
Conditions
Brief summary
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.
Interventions
DEVICEPercutaneous Vertebroplasty with Rotary Cutter
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
DEVICEConventional Percutaneous Vertebroplasty
The cement is injected into the bone metastases directly.
Sponsors
Li Min
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Imaging-proven and pathology-proven metastases 2. Intractable pain with neurologic dysfunction
Exclusion criteria
1\. Poor general condition without tolerance of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Back pain: Visual analogue scales system | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The patterns of cement opacification | during the procedure of vertebroplasty | 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). |
| Cement leakage | during the procedure of vertebroplasty | The presence or absence of cement leakage is assessed in the groups with and without rotary cutter. |
| Cement volume | during the procedure of vertebroplasty | The injected cement volume were evaluated in the two groups. |
Countries
China
Contacts
Primary ContactMin Li, M.D.
Outcome results
None listed