Lumbar SpondylolisthesisNCT05480267
A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
A study testing surgical treatment for lumbar spondylolisthesis in people with Lumbar Spondylolisthesis and Unilateral Biportal Endoscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved for the treatment of lumbar spondylolisthesis (LSP). The present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique
- What is being tested?
- surgical treatment for lumbar spondylolisthesis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lumbar spondylolisthesis,
- 40 yrs<age< 75yrs
- fusion levels <2
Who cannot join
- greater than Lenke-slivia classification III
- severe osteoporosis (t value <2.5)
- ASA 》IV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial
Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved for the treatment of lumbar spondylolisthesis (LSP). The present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures.
Read the detailed description
Lumbar spondylolisthesis (LSP) is the most common degenerative lumbar disease in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new direction for spinal surgeons to treat LSP. Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved. The results of pilot studies showed that it had the advantages of less traumas, fewer complications, quicker recover，and the clinical and imaging outcome was remarkable. Therefore, the present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish two-year follow-up to further quantify the clinical and imaging outcome of UBE. Therefore, the present study will further verify and quantify the safety and effectiveness of the UBE in the treatment of LSP on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of LSP.
- Conditions
- Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique, Surgical Treatment
- Being tested
- surgical treatment for lumbar spondylolisthesis
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical treatment for lumbar spondylolisthesisProcedure or surgery
There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF
| Study group | Role | What they receive |
|---|---|---|
| UBE | Experimental | The patient treated with unilateral biportal endoscopy (UBE) Receives: Procedure: surgical treatment for lumbar spondylolisthesis |
| MIS-TLIF | Active comparator | The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF) Receives: Procedure: surgical treatment for lumbar spondylolisthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
ODI score
the D-value between the preoperative ODI score and 2-year-postoperative ODI score
Measured: 2 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lumbar SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital
- Responsible party
- Principal investigator, Li fangcai, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Gang CHEN, MD., Principal investigator, 2nd hospital, School of Medicine, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480267
- Sponsor's protocol ID
- UBE vs. MIS-TLIF
- Status last verified
- Jul 2022
- First submitted
- 28 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have not decided when to share the plan. We plan to share it after the study completion.
Publications
MUTCH J, WALMSLEY R. The aetiology of cleft vertebral arch in spondylolisthesis. Lancet. 1956 Jan 14;270(6907):74-7. doi: 10.1016/s0140-6736(56)92130-4. No abstract available.
PubMed 13287061Oster BA, Kikanloo SR, Levine NL, Lian J, Cho W. Systematic Review of Outcomes Following 10-Year Mark of Spine Patient Outcomes Research Trial (SPORT) for Degenerative Spondylolisthesis. Spine (Phila Pa 1976). 2020 Jun 15;45(12):820-824. doi: 10.1097/BRS.0000000000003485.
PubMed 32205705Kwon JW, Park Y, Lee BH, Yoon SR, Ha JW, Kim H, Suk KS, Moon SH, Kim HS, Lee HM. Ten-Year Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion in Patients With Single-Level Lumbar Spondylolisthesis. Spine (Phila Pa 1976). 2022 Jun 1;47(11):773-780. doi: 10.1097/BRS.0000000000004334. Epub 2022 Feb 3.
PubMed 35125463Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.
PubMed 31542473Lightsey HM 4th, Pisano AJ, Striano BM, Crawford AM, Xiong GX, Hershman S, Schoenfeld AJ, Simpson AK. ALIF Versus TLIF for L5-S1 Isthmic Spondylolisthesis: ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures Domains. Spine (Phila Pa 1976). 2022 Jun 1;47(11):808-816. doi: 10.1097/BRS.0000000000004333. Epub 2022 Feb 3.
PubMed 35125462Heo DH, Lee DC, Park CK. Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis: biportal endoscopy, uniportal endoscopy, and microsurgery. Neurosurg Focus. 2019 May 1;46(5):E9. doi: 10.3171/2019.2.FOCUS197.
PubMed 31042664
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05480267
- Acronym / sponsor ID
- UBE vs. MIS-TLIF
- Conditions
- Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique, Surgical Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 29 Jul 2022 (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.
Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved for the treatment of lumbar spondylolisthesis (LSP). The present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures.
Detailed description
Lumbar spondylolisthesis (LSP) is the most common degenerative lumbar disease in the elderly, and the severe patients need surgical treatment. The elderly are often complicated with many medical diseases and the perioperative risk is high, so minimally invasive surgery is a new direction for spinal surgeons to treat LSP. Unilateral biportal endoscopy (UBE) is a new spinal minimally invasive technique improved. The results of pilot studies showed that it had the advantages of less traumas, fewer complications, quicker recover，and the clinical and imaging outcome was remarkable. Therefore, the present study aims to establish a multicenter, large sample, randomized controlled study to explore the technical advantages and surgical indications of this new technique in the treatment of LSP by comparing with the classical minimally invasive posterior spinal interbody fusion; (2) to compare the postoperative clinical and imaging results and analyze the surgical complications and preventive measures; (3) to establish two-year follow-up to further quantify the clinical and imaging outcome of UBE. Therefore, the present study will further verify and quantify the safety and effectiveness of the UBE in the treatment of LSP on the basis of previous studies, and provide a new clinical approach for minimally invasive treatment of LSP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UBE | Experimental | Procedure: surgical treatment for lumbar spondylolisthesisThe patient treated with unilateral biportal endoscopy (UBE) |
| MIS-TLIF | Active comparator | Procedure: surgical treatment for lumbar spondylolisthesisThe patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Lumbar spondylolisthesis,
- 40 yrs<age< 75yrs
- fusion levels <2
Key exclusion criteria (3 listed)
- greater than Lenke-slivia classification III
- severe osteoporosis (t value <2.5)
- ASA 》IV
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 |
|---|---|---|
| surgical treatment for lumbar spondylolisthesisThere are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF | Procedure or surgery | MIS-TLIF, UBE |
Primary outcome
ODI score
Time frame: 2 year postoperatively
the D-value between the preoperative ODI score and 2-year-postoperative ODI score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Results publication: PubMed 13287061MUTCH J, WALMSLEY R. The aetiology of cleft vertebral arch in spondylolisthesis. Lancet. 1956 Jan 14;270(6907):74-7. doi: 10.1016/s0140-6736(56)92130-4. No abstract available.
- Results publication: PubMed 32205705Oster BA, Kikanloo SR, Levine NL, Lian J, Cho W. Systematic Review of Outcomes Following 10-Year Mark of Spine Patient Outcomes Research Trial (SPORT) for Degenerative Spondylolisthesis. Spine (Phila Pa 1976). 2020 Jun 15;45(12):820-824. doi: 10.1097/BRS.0000000000003485.
- Results publication: PubMed 35125463Kwon JW, Park Y, Lee BH, Yoon SR, Ha JW, Kim H, Suk KS, Moon SH, Kim HS, Lee HM. Ten-Year Outcomes of Minimally Invasive Versus Open Transforaminal Lumbar Interbody Fusion in Patients With Single-Level Lumbar Spondylolisthesis. Spine (Phila Pa 1976). 2022 Jun 1;47(11):773-780. doi: 10.1097/BRS.0000000000004334. Epub 2022 Feb 3.
- Results publication: PubMed 31542473Park SM, Park J, Jang HS, Heo YW, Han H, Kim HJ, Chang BS, Lee CK, Yeom JS. Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial. Spine J. 2020 Feb;20(2):156-165. doi: 10.1016/j.spinee.2019.09.015. Epub 2019 Sep 19.
- Results publication: PubMed 35125462Lightsey HM 4th, Pisano AJ, Striano BM, Crawford AM, Xiong GX, Hershman S, Schoenfeld AJ, Simpson AK. ALIF Versus TLIF for L5-S1 Isthmic Spondylolisthesis: ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures Domains. Spine (Phila Pa 1976). 2022 Jun 1;47(11):808-816. doi: 10.1097/BRS.0000000000004333. Epub 2022 Feb 3.
- Results publication: PubMed 31042664Heo DH, Lee DC, Park CK. Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis: biportal endoscopy, uniportal endoscopy, and microsurgery. Neurosurg Focus. 2019 May 1;46(5):E9. doi: 10.3171/2019.2.FOCUS197.
- Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosisLink provided by the sponsor.
- ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome MeasuresLink provided by the sponsor.
- Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trialLink provided by the sponsor.
- Individual participant dataSharing planned: No. We have not decided when to share the plan. We plan to share it after the study completion.
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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.
Gang CHEN, MD. principal investigator
2nd hospital, School of Medicine, Zhejiang University
Questions about this trial
What is this clinical trial studying?
A study testing surgical treatment for lumbar spondylolisthesis in people with Lumbar Spondylolisthesis and Unilateral Biportal Endoscopy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 3 inclusion and 3 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 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Zhi-wei WANG, Ph.D and MD. (0571-87783759, keyanlunli_zheer@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ODI score (time frame: 2 year postoperatively). 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 NCT05480267, which also lists 6 linked publications.
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 29 Jul 2022.