Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

July 13, 2019 updated by: Li Min

Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250031
        • Recruiting
        • 960 Hospital of PLA
        • Contact:
          • Min Li, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Back pain: Visual analogue scales system
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The patterns of cement opacification
Time Frame: 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).
during the procedure of vertebroplasty
Cement leakage
Time Frame: during the procedure of vertebroplasty
The presence or absence of cement leakage is assessed in the groups with and without rotary cutter.
during the procedure of vertebroplasty
Cement volume
Time Frame: during the procedure of vertebroplasty
The injected cement volume were evaluated in the two groups.
during the procedure of vertebroplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Min

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 30, 2019

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 13, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 16, 2019

Last Update Submitted That Met QC Criteria

July 13, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 960HP20190051

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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