MetastasisNCT04017728
Percutaneous Vertebroplasty Using Rotary Cutter for Bone Metastases
A study testing Conventional Percutaneous Vertebroplasty and Percutaneous Vertebroplasty with Rotary Cutter in people with Metastasis, run by Li Min at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastasis
- What is being tested?
- Conventional Percutaneous Vertebroplasty and Percutaneous Vertebroplasty with Rotary Cutter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Imaging-proven and pathology-proven metastases
- Intractable pain with neurologic dysfunction
Who cannot join
- 1. Poor general condition without tolerance of surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
960 Hospital of PLA
Jinan, Shandong, 250031
Min Li, M.D.
About this study
Official title: Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases
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.
- Conditions
- Metastasis
- Being tested
- Conventional Percutaneous Vertebroplasty, Percutaneous Vertebroplasty with Rotary Cutter
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Percutaneous VertebroplastyDevice
The cement is injected into the bone metastases directly.
Percutaneous Vertebroplasty with Rotary CutterDevice
The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Percutaneous Vertebroplasty | Active comparator | The cement is injected after the successful puncture. Receives: Device: Conventional Percutaneous Vertebroplasty |
| Percutaneous Vertebroplasty with Rotary Cutter | Experimental | The rotary cutter is applied to destroy the metastatic lesion before coment injection. Receives: Device: Percutaneous Vertebroplasty with Rotary Cutter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (3)
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).
Measured: during the procedure of vertebroplasty
Cement leakage
The presence or absence of cement leakage is assessed in the groups with and without rotary cutter.
Measured: during the procedure of vertebroplasty
Cement volume
The injected cement volume were evaluated in the two groups.
Measured: during the procedure of vertebroplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start30 Jul 2019 (estimated)
- Primary completionApr 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetastasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Li Min
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Li Min, Jinan Military General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017728
- Sponsor's protocol ID
- 960HP20190051
- Status last verified
- Jul 2019
- First submitted
- 13 Apr 2019
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Vertebroplasty Using Rotary Cutter for Treating Bone Metastases
- ClinicalTrials.gov ID
- NCT04017728
- Acronym / sponsor ID
- 960HP20190051
- Conditions
- Metastasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- 30 Jul 2019 (estimated)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Percutaneous Vertebroplasty | Active comparator | Device: Conventional Percutaneous VertebroplastyThe cement is injected after the successful puncture. |
| Percutaneous Vertebroplasty with Rotary Cutter | Experimental | Device: Percutaneous Vertebroplasty with Rotary CutterThe rotary cutter is applied to destroy the metastatic lesion before coment injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Imaging-proven and pathology-proven metastases
- Intractable pain with neurologic dysfunction
Key exclusion criteria (1 listed)
- 1. Poor general condition without tolerance of surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional Percutaneous VertebroplastyThe cement is injected into the bone metastases directly. | Device | Conventional Percutaneous Vertebroplasty |
| Percutaneous Vertebroplasty with Rotary CutterThe rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure. | Device | Percutaneous Vertebroplasty with Rotary Cutter |
Primary outcome
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.
3 secondary outcomes
The patterns of cement opacification
Time frame: during the procedure of vertebroplasty
Cement leakage
Time frame: during the procedure of vertebroplasty
Cement volume
Time frame: during the procedure of vertebroplasty
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional Percutaneous Vertebroplasty and Percutaneous Vertebroplasty with Rotary Cutter in people with Metastasis, run by Li Min at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Li, M.D. (13953176057, liminyingxiang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain: Visual analogue scales system (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2019; AzTrials last refreshed its copy on 2 Nov 2026.