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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
Sponsor:
Information provided by (Responsible Party):
Li Min, Jinan Military General Hospital

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.

Condition or disease Intervention/treatment Phase
Metastasis Device: Conventional Percutaneous Vertebroplasty Device: Percutaneous Vertebroplasty with Rotary Cutter Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. Cement volume [ Time Frame: during the procedure of vertebroplasty ]
    The injected cement volume were evaluated in the two groups.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Min Li, M.D. 13953176057 liminyingxiang@163.com

Locations
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China, Shandong
960 Hospital of PLA Recruiting
Jinan, Shandong, China, 250031
Contact: Min Li, M.D.         
Sponsors and Collaborators
Li Min

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Responsible Party: Li Min, Vice Director, Jinan Military General Hospital
ClinicalTrials.gov Identifier: NCT04017728     History of Changes
Other Study ID Numbers: 960HP20190051
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes