Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2019
CompletedFirst Posted
Study publicly available on registry
July 12, 2019
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedJuly 16, 2019
July 1, 2019
4.7 years
April 13, 2019
July 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
3 months
Secondary Outcomes (3)
The patterns of cement opacification
during the procedure of vertebroplasty
Cement leakage
during the procedure of vertebroplasty
Cement volume
during the procedure of vertebroplasty
Study Arms (2)
Conventional Percutaneous Vertebroplasty
ACTIVE COMPARATORThe cement is injected after the successful puncture.
Percutaneous Vertebroplasty with Rotary Cutter
EXPERIMENTALThe rotary cutter is applied to destroy the metastatic lesion before coment injection.
Interventions
The cement is injected into the bone metastases directly.
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
Eligibility Criteria
You may qualify if:
- Imaging-proven and pathology-proven metastases
- Intractable pain with neurologic dysfunction
You may not qualify if:
- \. Poor general condition without tolerance of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Li Minlead
Study Sites (1)
960 Hospital of PLA
Jinan, Shandong, 250031, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Vice Director
Study Record Dates
First Submitted
April 13, 2019
First Posted
July 12, 2019
Study Start
July 30, 2019
Primary Completion
April 1, 2024
Study Completion
December 1, 2025
Last Updated
July 16, 2019
Record last verified: 2019-07