Lumbar Disc HerniationNCT05033457
Comparative Study Between UBE and PETD for the Treatment of Lumbar Spinal Canal Stenosis
An observational study of Lumbar Disc Herniation, run by Shaanxi Provincial People's Hospital at 1 site in China.
Trial summary
OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients with lumbar spinal stenosis, with low back pain and neurological urgency.The patient cannot relieve symptoms after 3 months or more of conservative treatment.
Who may be able to join
- Single-segment lumbar disc herniation/lumbar spinal stenosis
- Single-segment lumbar disc herniation Symptoms of nerve compression
Who cannot join
- Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes
- foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis
OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.
METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.
Read the detailed description
It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.
The investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).
- Conditions
- Lumbar Disc Herniation
- Being tested
- unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy
- 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.
unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomyProcedure or surgery
Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.
| Study group | Role | What they receive |
|---|---|---|
| unilateral biportal endoscopy technique group | Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group Receives: Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy | |
| percutaneous endoscopic transforaminal discectomy group | Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group Receives: Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of the preoperative lumbar intervertebral disc
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
Measured: preoperative
Cross-sectional area of the preoperative spinal canal
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.
Measured: preoperative
Cross-sectional area of the postoperative lumbar intervertebral disc
The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
Measured: 3 months after surgery
preoperative ODI
According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.
Measured: preoperative
ODI on 3 months after operation
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.
Measured: 3 months after surgery
ODI at the final follow-up
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.
Measured: Final follow-up
preoperative VAS back pain score
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.
Measured: preoperative
preoperative VAS leg pain score
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.
Measured: preoperative
VAS back pain score on postoperative day 1
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.
Measured: 1 day after operation
VAS leg pain score on postoperative day 1
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.
Measured: 1 day after operation
VAS back pain score on 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.
Measured: 3 months after operation
VAS leg pain score on 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.
Measured: 3 months after operation
VAS back pain score at the final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.
Measured: Final follow-up
VAS leg pain score at the final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.
Measured: Final follow-up
Secondary outcomes (2)
operation time
Collect the operation time of participants during the operation.
Measured: intraoperative
incision size
Collect the incision size of participants during the operation.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaanxi Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rongcan Liu, Shaanxi Provincial People's Hospital
- Investigators
- Jingpeng Wei, Study chair, Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033457
- Sponsor's protocol ID
- sxsrmyyjzwc202101
- Status last verified
- Jan 2021
- First submitted
- 9 Aug 2021
- Last updated
- 2 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Unilateral Biportal Endoscopy Technique and Percutaneous Endoscopic Transforaminal Discectomy for the Treatment of Lumbar Spinal Canal Stenosis
- ClinicalTrials.gov ID
- NCT05033457
- Acronym / sponsor ID
- sxsrmyyjzwc202101
- Conditions
- Lumbar Disc Herniation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shaanxi Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Sep 2021 (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.
OBJECTIVE Both unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD) are minimally invasive and effective surgical procedures for lumbar spinal stenosis.The object of this retrospective study was to compare the clinical and radiological outcomes between UBE and PETD.
METHODS In the period from July 2020 to December 2020, using UBE or PETD to treat lumbar canal stenosis.Patients were classified into two groups based on the surgery they had undergone. Preoperative and postoperative MR image was used to evaluate the removal rate of lumbar disc herniated material by two surgical methods. The two surgical methods are also compared and evaluated in terms of operation time, incision size, hospitalization time, etc.
Detailed description
It was performed as a retrospective analysis of prospectively collected data on patients received spinal endoscopic decompression between July 2020 to December 2020 was conducted. All patients underwent lumbar MRI examination with the result of L5-S1 disc herniation，accompanied by claudication or lower extremity radiation pain and other nerve compression symptoms. The symptoms have not improved with conservative treatments including physical therapy, medication, and epidural injection procedures for a minimum of 12 weeks. Patients who hadprevious spine surgery, infection, trauma, tumors or spondylolisthesis were excluded. The surgery was performed by the same experienced spinal surgeon and the surgical patient were closely followed for 3 months after surgery.
The investigators performed two kinds of endoscopic lumbar discectomy：unilateral biportal endoscopy technique(UBE) and percutaneous endoscopic transforaminal discectomy(PETD).
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral biportal endoscopy technique group | – | Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomyTreatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group |
| percutaneous endoscopic transforaminal discectomy group | – | Procedure: unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomyTreatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with lumbar spinal stenosis, with low back pain and neurological urgency.The patient cannot relieve symptoms after 3 months or more of conservative treatment.
Key inclusion criteria (2 listed)
- Single-segment lumbar disc herniation/lumbar spinal stenosis
- Single-segment lumbar disc herniation Symptoms of nerve compression
Key exclusion criteria (2 listed)
- Multi-segment lumbar disc herniation / lumbar spinal stenosis、Have received surgery、Hypertension、Diabetes
- foraminal and extraforaminal disc herniation multilevel disc herniation, spinal stenosis spondylolisthesis scoliosis prior lumbar surgery spinal infection spinal tumor a history of hip or knee arthritis
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 |
|---|---|---|
| unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomyTreatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group. | Procedure or surgery | percutaneous endoscopic transforaminal discectomy group, unilateral biportal endoscopy technique group |
Primary outcome
Cross-sectional area of the preoperative lumbar intervertebral disc
Time frame: preoperative
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
Cross-sectional area of the preoperative spinal canal
Time frame: preoperative
The preoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the spinal canal of the diseased segment.
Cross-sectional area of the postoperative lumbar intervertebral disc
Time frame: 3 months after surgery
The postoperative axial T2-weighted MRI slices of the patient can be used to measure the cross-sectional area of the intervertebral disc of the diseased segment.
preoperative ODI
Time frame: preoperative
According to the Oswestry Disability Index (ODI), evaluate the preoperative ODI of participants.
ODI on 3 months after operation
Time frame: 3 months after surgery
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants on 3 months after operation.
ODI at the final follow-up
Time frame: Final follow-up
According to the Oswestry Disability Index (ODI), evaluate the ODI of participants at the final follow-up.
preoperative VAS back pain score
Time frame: preoperative
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS back pain score of participants.
preoperative VAS leg pain score
Time frame: preoperative
According to the visual analog scale (VAS) scoring standard, assess the preoperative VAS leg pain score of participants.
VAS back pain score on postoperative day 1
Time frame: 1 day after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on postoperative day 1.
VAS leg pain score on postoperative day 1
Time frame: 1 day after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on postoperative day 1.
VAS back pain score on 3 months after operation
Time frame: 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants on 3 months after operation.
VAS leg pain score on 3 months after operation
Time frame: 3 months after operation
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants on 3 months after operation.
VAS back pain score at the final follow-up
Time frame: Final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS back pain score of participants at the final follow-up.
VAS leg pain score at the final follow-up
Time frame: Final follow-up
According to the visual analog scale (VAS) scoring standard, assess the VAS leg pain score of participants at the final follow-up.
2 secondary outcomes
operation time
Time frame: intraoperative
incision size
Time frame: intraoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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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.
Jingpeng Wei study chair
Shanxi Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Disc Herniation, run by Shaanxi Provincial People's Hospital 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 2 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: enrolling by invitation, as of the sponsor's last update on 2 Sep 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional area of the preoperative lumbar intervertebral disc (time frame: preoperative). The study lists 14 primary outcomes in all. 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 2 Sep 2021.