Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases

Not Applicable

Recruiting

• Conditions: Metastasis
• Interventions: Device: Percutaneous Vertebroplasty with Rotary Cutter; Device: Conventional Percutaneous Vertebroplasty

• Registration Number: NCT04017728
• Lead Sponsor: Li Min

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-13
• Status Verified: 2019-07
• Study First Submitted QC: 2019-07-11
• Study First Posted: 2019-07-12
• Last Update Submitted: 2019-07-13
• Last Update Posted: 2019-07-16
• Study Start: 2019-07-30
• Primary Completion: 2024-04
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous Vertebroplasty with Rotary Cutter	Percutaneous Vertebroplasty with Rotary Cutter	The rotary cutter is applied to destroy the metastatic lesion before coment injection.
Conventional Percutaneous Vertebroplasty	Conventional Percutaneous Vertebroplasty	The cement is injected after the successful puncture.

Primary Outcome Measures

Name	Time	Method
Back pain: Visual analogue scales system	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

960 Hospital of PLA; 🇨🇳 Jinan, Shandong, China