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出境医 / 临床实验 / Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
Study Description
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 |
Study Design
| 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 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Conventional Percutaneous Vertebroplasty
The cement is injected after the successful puncture.
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Device: Conventional Percutaneous Vertebroplasty
The cement is injected into the bone metastases directly.
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Experimental: Percutaneous Vertebroplasty with Rotary Cutter
The rotary cutter is applied to destroy the metastatic lesion before coment injection.
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Device: Percutaneous Vertebroplasty with Rotary Cutter
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
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Outcome Measures
Primary Outcome Measures :
- 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 :
- 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.
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Imaging-proven and pathology-proven metastases
- Intractable pain with neurologic dysfunction
Exclusion Criteria:
1. Poor general condition without tolerance of surgery
Contacts and Locations
Contacts
| Contact: Min Li, M.D. | 13953176057 | liminyingxiang@163.com |
Locations
| China, Shandong | |
| 960 Hospital of PLA | Recruiting |
| Jinan, Shandong, China, 250031 | |
| Contact: Min Li, M.D. | |
Sponsors and Collaborators
Li Min
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 13, 2019 | ||||
| First Posted Date ICMJE | July 12, 2019 | ||||
| Last Update Posted Date | July 16, 2019 | ||||
| Estimated Study Start Date ICMJE | July 30, 2019 | ||||
| Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases | ||||
| Official Title ICMJE | Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases | ||||
| 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 Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Metastasis | ||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
70 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 2025 | ||||
| Estimated Primary Completion Date | April 2024 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria: 1. Poor general condition without tolerance of surgery |
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| Sex/Gender ICMJE |
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| Ages ICMJE | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04017728 | ||||
| Other Study ID Numbers ICMJE | 960HP20190051 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Li Min, Jinan Military General Hospital | ||||
| Study Sponsor ICMJE | Li Min | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Jinan Military General Hospital | ||||
| Verification Date | July 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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