Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

Metastasis Clinical Trial

Official title:

Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04017728
• Other study ID #: 960HP20190051
• Status: Recruiting
• Phase: N/A
• Start date: July 30, 2019
• Est. completion date: December 2025

Study information

• Verified date: July 2019
• Source: Jinan Military General Hospital
• Contact: Min Li, M.D.
• Phone: 13953176057
• Email: liminyingxiang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Metastasis
• Neoplasm Metastasis

Intervention

Device:
• Conventional Percutaneous Vertebroplasty
The cement is injected into the bone metastases directly.
• Percutaneous Vertebroplasty with Rotary Cutter
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.

Locations

Country	Name	City	State
China	960 Hospital of PLA	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Li Min

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	during the procedure of vertebroplasty
Secondary	Cement leakage	The presence or absence of cement leakage is assessed in the groups with and without rotary cutter.	during the procedure of vertebroplasty
Secondary	Cement volume	The injected cement volume were evaluated in the two groups.	during the procedure of vertebroplasty