Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

NCT ID: NCT04017728

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2025-12-31

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.

Detailed Description

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Conditions

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Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Conventional Percutaneous Vertebroplasty

The cement is injected after the successful puncture.

Group Type ACTIVE_COMPARATOR

Conventional Percutaneous Vertebroplasty

Intervention Type DEVICE

The cement is injected into the bone metastases directly.

Percutaneous Vertebroplasty with Rotary Cutter

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

Group Type EXPERIMENTAL

Percutaneous Vertebroplasty with Rotary Cutter

Intervention Type DEVICE

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

Interventions

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Conventional Percutaneous Vertebroplasty

The cement is injected into the bone metastases directly.

Intervention Type DEVICE

Percutaneous Vertebroplasty with Rotary Cutter

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Li Min

OTHER

Sponsor Role lead

Responsible Party

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Li Min

Vice Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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960 Hospital of PLA

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Min Li, M.D.

Role: CONTACT

13953176057

Facility Contacts

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Min Li, M.D.

Role: primary

Other Identifiers

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960HP20190051

Identifier Type: -

Identifier Source: org_study_id

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