Lumbar Herniated DiscNCT03403244
US-MR Image Fusion-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation
A study testing US-MR image fusion-guided PTED and fluoroscopy-guided PTED in people with Lumbar Herniated Disc, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Herniated Disc
- What is being tested?
- US-MR image fusion-guided PTED and fluoroscopy-guided PTED
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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
- persistent radicular pain.
- an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient
- single responsible segment of lumbar disc herniation
- L4-5 segment
Who cannot join
- Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
- Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
- Equal to or more than two responsible level
- Previous spinal surgery
- unable to collaborate during surgery
- far-lateral disc herniation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
Limin Rong, M.D., 862085252900, ronglimin@21cn.com
About this study
Official title: US-MR Image Fusion-guided Versus Fluoroscopy-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation: a Comparative Cohort Study
The purpose of this study is to evaluate the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation
Read the detailed description
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) a widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. However, the use of fluoroscopy may be usually required to indirectly visualize pertinent anatomy to achieve an optimal result on radiographs. As we known, increased radiation exposure may be associated with potential stochastic and deterministic adverse events. Therefore, it is important to reduce the radiation dose of practitioners to minimize risk of potential radiation-induced complications.
Ultrasound-MR fusion technique combines the advantages of ultrasound and MR, and overcome the shortcomings of each single imaging method. It provides MR cross-sectional multiplanar images that correspond to the acquired real-time US images, and all images can be displayed simultaneously and in real time according to the angle of the US transducer. US-MR fusion image has been widely used in prostate and liver intervention. However, to our limited knowledge, there is only one research about the application of US-MR fusion image in lumbar spinal surgery.
In this study, a comparative cohort study will be performed to evaluate feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation(LDH). We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.
Two groups of patients will be investigated: patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED (US-MR PTED), and fluoroscopy-guided PTED (FL PTED).
The primary outcomes of the study will be radiation exposure and puncture time. Secondary outcomes include fusion efficacy, puncture accuracy, puncture satisfaction of surgeon, comfort of patient and clinical effectiveness.
On the basis of the results of this trial we will, for the first time, have scientific evidence as to the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation.
- Conditions
- Lumbar Herniated Disc
- Being tested
- US-MR image fusion-guided PTED, fluoroscopy-guided PTED
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US-MR image fusion-guided PTEDProcedure or surgery
patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED
fluoroscopy-guided PTEDProcedure or surgery
patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED
| Study group | Role | What they receive |
|---|---|---|
| US-MR image fusion-guided PTED | Experimental | US-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique. Receives: Procedure: US-MR image fusion-guided PTED |
| fluoroscopy-guided PTED | Active comparator | fluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy. Receives: Procedure: fluoroscopy-guided PTED |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiation exposure
dose of radiation exposure
Measured: during operation
Secondary outcomes (6)
puncture accuracy
the accuracy of puncture position confirmed by fluoroscopy.
Measured: during operation
puncture satisfaction of surgeon
use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more satisfactory) to evaluate the satisfaction of surgeon during puncture
Measured: during operation
comfort of patient
use Visual Analog Scales (VAS,scores ranging from 0 to 10, with higher scores indicating more comfortable) to evaluate the comfort of patient during puncture
Measured: during operation
degree of pain
Visual Analog Scales (VAS, scores ranging from 0 to 10, with higher scores indicating more severe pain)
Measured: preoperation, immediately postoperation, 1 week postoperation
degree of disability
Oswestry Disability Index (ODI) score (ranging from 0 to 100, with higher scores indicating more disability related to pain）
Measured: preoperation, immediately postoperation, 1 week postoperation
puncture time
the time from the begin of puncture to the confirmation of optimal puncture
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Herniated DiscStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Limin Rong, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403244
- Sponsor's protocol ID
- US-MR guided PTED for LDH
- Status last verified
- Apr 2018
- First submitted
- 4 Jan 2018
- Last updated
- 4 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xie P, Feng F, Cao J, Chen Z, He B, Kang Z, He L, Wu W, Tan L, Li K, Zheng R, Rong L. Real-time ultrasonography-magnetic resonance image fusion navigation for percutaneous transforaminal endoscopic discectomy. J Neurosurg Spine. 2020 Mar 27;33(2):192-198. doi: 10.3171/2020.1.SPINE191223. Print 2020 Aug 1.
PubMed 32217792
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US-MR Image Fusion-guided Versus Fluoroscopy-guided Percutaneous Transforaminal Endoscopic Discectomy for the Treatment of Lumbar Disc Herniation: a Comparative Cohort Study
- ClinicalTrials.gov ID
- NCT03403244
- Acronym / sponsor ID
- US-MR guided PTED for LDH
- Conditions
- Lumbar Herniated Disc
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 18 Jan 2018 (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.
The purpose of this study is to evaluate the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation
Detailed description
Lumbar disc herniation (LDH) is a common pathological process leading to spinal surgery. Open discectomy used to be a widespread procedure for surgical treatment for symptomatic LDH. Currently, with rapid progress of endoscopic techniques, several minimal invasive endoscopic surgeries have been developed to perform discectomy. Percutaneous transforaminal endoscopic discectomy (PTED) a widely used minimal invasive surgical procedures, the effectiveness of which has been proved to be comparable to conventional open discectomy. However, the use of fluoroscopy may be usually required to indirectly visualize pertinent anatomy to achieve an optimal result on radiographs. As we known, increased radiation exposure may be associated with potential stochastic and deterministic adverse events. Therefore, it is important to reduce the radiation dose of practitioners to minimize risk of potential radiation-induced complications.
Ultrasound-MR fusion technique combines the advantages of ultrasound and MR, and overcome the shortcomings of each single imaging method. It provides MR cross-sectional multiplanar images that correspond to the acquired real-time US images, and all images can be displayed simultaneously and in real time according to the angle of the US transducer. US-MR fusion image has been widely used in prostate and liver intervention. However, to our limited knowledge, there is only one research about the application of US-MR fusion image in lumbar spinal surgery.
In this study, a comparative cohort study will be performed to evaluate feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation(LDH). We will conduct the study at the 3rd affiliated hospitals of Sun Yat-Sen University.
Two groups of patients will be investigated: patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED (US-MR PTED), and fluoroscopy-guided PTED (FL PTED).
The primary outcomes of the study will be radiation exposure and puncture time. Secondary outcomes include fusion efficacy, puncture accuracy, puncture satisfaction of surgeon, comfort of patient and clinical effectiveness.
On the basis of the results of this trial we will, for the first time, have scientific evidence as to the feasibility and efficacy of US-MR image fusion-guided percutaneous transforaminal endoscopic discectomy for the treatment of lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-MR image fusion-guided PTED | Experimental | Procedure: US-MR image fusion-guided PTEDUS-MR image fusion-guided PTED: the puncture procedure during PTED was performed under the guidance of ultrasound-MR fusion technique. |
| fluoroscopy-guided PTED | Active comparator | Procedure: fluoroscopy-guided PTEDfluoroscopy-guided PTED: the puncture procedure during PTED was performed under the guidance of fluoroscopy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- persistent radicular pain.
- an imaging study (MRI or CT) showing LDH at a level and side corresponding to the patient
- single responsible segment of lumbar disc herniation
- L4-5 segment
Key exclusion criteria (6 listed)
- Cauda equina syndrome or progressive neurologic deficit requiring urgent surgical intervention
- Combination with other spinal disorder requiring advanced surgery (such as lumbar stenosis, spondylolisthesis, deformity, fracture, infection, tumor and so on)
- Equal to or more than two responsible level
- Previous spinal surgery
- unable to collaborate during 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 |
|---|---|---|
| US-MR image fusion-guided PTEDpatients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED | Procedure or surgery | US-MR image fusion-guided PTED |
| fluoroscopy-guided PTEDpatients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED | Procedure or surgery | fluoroscopy-guided PTED |
Primary outcome
radiation exposure
Time frame: during operation
dose of radiation exposure
6 secondary outcomes
puncture accuracy
Time frame: during operation
puncture satisfaction of surgeon
Time frame: during operation
comfort of patient
Time frame: during operation
degree of pain
Time frame: preoperation, immediately postoperation, 1 week postoperation
degree of disability
Time frame: preoperation, immediately postoperation, 1 week postoperation
puncture time
Time frame: during operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2018.
- Derived from this study: PubMed 32217792Xie P, Feng F, Cao J, Chen Z, He B, Kang Z, He L, Wu W, Tan L, Li K, Zheng R, Rong L. Real-time ultrasonography-magnetic resonance image fusion navigation for percutaneous transforaminal endoscopic discectomy. J Neurosurg Spine. 2020 Mar 27;33(2):192-198. doi: 10.3171/2020.1.SPINE191223. Print 2020 Aug 1.
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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 US-MR image fusion-guided PTED and fluoroscopy-guided PTED in people with Lumbar Herniated Disc, run by Third Affiliated Hospital, Sun Yat-Sen University 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 4 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 4 Apr 2018. 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 Limin Rong, MD (+862085252900, ronglimin@21cn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiation exposure (time frame: during operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03403244, which also lists 1 linked publication.
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 4 Apr 2018.