Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

Li Min

Status: Enrolling

Conditions: Metastasis

Treatments: Device: Percutaneous Vertebroplasty with Rotary Cutter; Device: Conventional Percutaneous Vertebroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT04017728

960HP20190051

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Conventional Percutaneous Vertebroplasty

Active Comparator group

Description:

The cement is injected after the successful puncture.

Treatment:

Device: Conventional Percutaneous Vertebroplasty

Percutaneous Vertebroplasty with Rotary Cutter

Experimental group

Description:

The rotary cutter is applied to destroy the metastatic lesion before coment injection.

Treatment:

Device: Percutaneous Vertebroplasty with Rotary Cutter