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Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

NCT04017728 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

  • Metastasis

Interventions

DEVICE

Conventional Percutaneous Vertebroplasty

The cement is injected into the bone metastases directly.

DEVICE

Percutaneous Vertebroplasty with Rotary Cutter

The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.

Sponsors & Collaborators

  • Li Min

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2024-04-30
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04017728 on ClinicalTrials.gov