Spine FractureNCT03850938
Percutaneous Kyphoplasty Using Rotary Cutter in Osteoporotic Vertebral Fractures
A study testing Conventional Kyphoplasty and Kyphoplasty with Rotary Cutter in people with Spine Fracture, run by Li Min at 1 site in China.
Trial summary
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Spine Fracture
- What is being tested?
- Conventional Kyphoplasty and Kyphoplasty 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
- 1 May 2019to 31 Dec 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
- Patient has read and sign the informed consent
- Male or female, 50 years or older
- Compressive and burst vertebral body fractures without any neurological deficit.
- Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
Who cannot join
- Neurological signs related to the vertebral fracture to treat
- Unmanageable bleeding disorder
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to bone cement
- Local or generalized infection
- Improvement of the symptoms of the patient with conservative management
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Min Li
Jinan, Shandong, 250031
Min Li, M.D., 13953176057, liminyingxiang@163.com
About this study
Official title: Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
- Conditions
- Spine Fracture
- Being tested
- Conventional Kyphoplasty, Kyphoplasty with Rotary Cutter
- Keywords
- fractures, compression, back pain, bone cements, kyphoplasty
- Medical subject headings
- Spinal Fractures, Fractures, Compression, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional KyphoplastyDevice
Also called Conventional PKP
The cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones.
Kyphoplasty with Rotary CutterDevice
Also called PKP with Rotary Cutter
The rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Kyphoplasty | Experimental | The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. Receives: Device: Conventional Kyphoplasty |
| Kyphoplasty with Rotary Cutter | Active comparator | The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration, which may induce a cavity with barriers pushed by balloon dilatation. Then, the structure of the cavity is destroyed by a rotary cutter. Finally, the cement is injected, which may effectively interdigitates with the healthy cancellous bone. Receives: Device: Kyphoplasty 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 post-operative back pain via Visual analogue scales system
Measured: up to 2 years
Secondary outcomes (5)
Refracture
Number of new vertebral fractures documented radiologically
Measured: up to 2 years
Kyphotic angle and global thoracic and lumbar angulations
Measured: up to 2 years
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 PKP
Height of the treated vertebral body
Follow-up of anterior, median and posterior height of the treated vertebral body, obtained by making an average of all measurements
Measured: Preoperative, up to 2 years
Medico-economic follow-up
Cost of intervention; Cost of prescribed medicines; Cost of follow-up visits; Cost of subsequent hospitalization; Cost of complications.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start1 May 2019 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine FractureStudies 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
- Care provider, Investigator, Outcomes assessor
- 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
- NCT03850938
- Sponsor's protocol ID
- 960HP20190012
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 22 Feb 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 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Kyphoplasty With and Without Rotary Cutter Subacute Osteoporotic Vertebral Fractures
- ClinicalTrials.gov ID
- NCT03850938
- Acronym / sponsor ID
- 960HP20190012
- Conditions
- Spine Fracture
- Keywords
- fractures, compression, back pain, bone cements, kyphoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Li MinUniversity, hospital or other
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Feb 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.
Kyphoplasty(PKP) is performed under general anaesthesia in patients with osteoporotic vertebral compression fracture. The balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. As the diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones, refractures are often found in patients with conventional PKP. Furthermore, the loss of restored height of surgical vertebrae due to refracture in PKP. The investigators will applied a rotary cutter to destroy the structure of the cavity created by the balloon. Finally, the cement is injected, which may effectively interdigitates with the surrounding cancellous bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Kyphoplasty | Experimental | Device: Conventional KyphoplastyThe balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration. Then, the cement is injected into the cavity created by the balloon. |
| Kyphoplasty with Rotary Cutter | Active comparator | Device: Kyphoplasty with Rotary CutterThe balloon is first placed into the fractured vertebra and inflated with contrast agent for height restoration, which may induce a cavity with barriers pushed by balloon dilatation. Then, the structure of the cavity is destroyed by a rotary cutter. Finally, the cement is injected, which may effectively interdigitates with the healthy cancellous bone. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient is able to undergo the vertebroplasty or balloon kyphoplasty procedure
- Patient has read and sign the informed consent
- Male or female, 50 years or older
- Compressive and burst vertebral body fractures without any neurological deficit.
- Persistent pain despite medical treatment according to VAS ≥ 5 or a last resort to morphine treatment
Key exclusion criteria (6 listed)
- Neurological signs related to the vertebral fracture to treat
- Unmanageable bleeding disorder
- History of surgical or percutaneous spine treatment except simple discectomy at a single or multiple vertebral levels with no residual pain.
- Known allergy to bone cement
- Local or generalized infection
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 KyphoplastyAlso: Conventional PKPThe cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones. | Device | Conventional Kyphoplasty |
| Kyphoplasty with Rotary CutterAlso: PKP with Rotary CutterThe rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely. | Device | Kyphoplasty with Rotary Cutter |
Primary outcome
Back pain: Visual analogue scales system
Time frame: up to 2 years
Measuring and comparing the post-operative back pain via Visual analogue scales system
5 secondary outcomes
Refracture
Time frame: up to 2 years
Kyphotic angle and global thoracic and lumbar angulations
Time frame: up to 2 years
The patterns of cement opacification
Time frame: during the procedure of PKP
Height of the treated vertebral body
Time frame: Preoperative, up to 2 years
Medico-economic follow-up
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 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 Kyphoplasty and Kyphoplasty with Rotary Cutter in people with Spine Fracture, 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 5 inclusion and 6 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 22 Feb 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back pain: Visual analogue scales system (time frame: up to 2 years). 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 22 Feb 2019.