Back to resultsPercutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
Primary Purpose
Metastasis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Conventional Percutaneous Vertebroplasty
Percutaneous Vertebroplasty with Rotary Cutter
Sponsored by
About this trial
This is an interventional treatment trial for Metastasis
Eligibility Criteria
Inclusion Criteria:
- Imaging-proven and pathology-proven metastases
- Intractable pain with neurologic dysfunction
Exclusion Criteria:
1. Poor general condition without tolerance of surgery
Sites / Locations
- 960 Hospital of PLARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Percutaneous Vertebroplasty
Percutaneous Vertebroplasty with Rotary Cutter
Arm Description
The cement is injected after the successful puncture.
The rotary cutter is applied to destroy the metastatic lesion before coment injection.
Outcomes
Primary Outcome Measures
Back pain: Visual analogue scales system
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 Outcome Measures
The patterns of cement opacification
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
The presence or absence of cement leakage is assessed in the groups with and without rotary cutter.
Cement volume
The injected cement volume were evaluated in the two groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04017728
Brief Title
Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
Official Title
Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Recruiting
Study Start Date
July 30, 2019 (Anticipated)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Min
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Percutaneous Vertebroplasty
Arm Type
Active Comparator
Arm Description
The cement is injected after the successful puncture.
Arm Title
Percutaneous Vertebroplasty with Rotary Cutter
Arm Type
Experimental
Arm Description
The rotary cutter is applied to destroy the metastatic lesion before coment injection.
Intervention Type
Device
Intervention Name(s)
Conventional Percutaneous Vertebroplasty
Intervention Description
The cement is injected into the bone metastases directly.
Intervention Type
Device
Intervention Name(s)
Percutaneous Vertebroplasty with Rotary Cutter
Intervention Description
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
Primary Outcome Measure Information:
Title
Back pain: Visual analogue scales system
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The patterns of cement opacification
Description
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).
Time Frame
during the procedure of vertebroplasty
Title
Cement leakage
Description
The presence or absence of cement leakage is assessed in the groups with and without rotary cutter.
Time Frame
during the procedure of vertebroplasty
Title
Cement volume
Description
The injected cement volume were evaluated in the two groups.
Time Frame
during the procedure of vertebroplasty
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Imaging-proven and pathology-proven metastases
Intractable pain with neurologic dysfunction
Exclusion Criteria:
1. Poor general condition without tolerance of surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Li, M.D.
Phone
13953176057
Email
liminyingxiang@163.com
Facility Information:
Facility Name
960 Hospital of PLA
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Li, M.D.
12. IPD Sharing Statement
Learn more about this trial
Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
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