Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
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|ClinicalTrials.gov Identifier: NCT04017728|
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastasis||Device: Conventional Percutaneous Vertebroplasty Device: Percutaneous Vertebroplasty with Rotary Cutter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases|
|Estimated Study Start Date :||July 30, 2019|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||December 2025|
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.
- 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.
- 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).
- 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.
- Cement volume [ Time Frame: during the procedure of vertebroplasty ]The injected cement volume were evaluated in the two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017728
|Contact: Min Li, M.D.||firstname.lastname@example.org|
|960 Hospital of PLA||Recruiting|
|Jinan, Shandong, China, 250031|
|Contact: Min Li, M.D.|