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A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis

NCT ID: NCT05480267

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-09-01

Brief Summary

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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

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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

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Lumbar Spondylolisthesis Unilateral Biportal Endoscopy Minimally Invasive Technique Surgical Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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UBE

The patient treated with unilateral biportal endoscopy (UBE)

Group Type EXPERIMENTAL

surgical treatment for lumbar spondylolisthesis

Intervention Type PROCEDURE

There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF

MIS-TLIF

The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)

Group Type ACTIVE_COMPARATOR

surgical treatment for lumbar spondylolisthesis

Intervention Type PROCEDURE

There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF

Interventions

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surgical treatment for lumbar spondylolisthesis

There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Lumbar spondylolisthesis,
* 40 yrs\<age\< 75yrs
* fusion levels \<2

Exclusion Criteria

* greater than Lenke-slivia classification III
* severe osteoporosis (t value \<2.5)
* ASA 》IV
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role collaborator

RenJi Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Li fangcai

Ph.D and MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gang CHEN, MD.

Role: PRINCIPAL_INVESTIGATOR

2nd hospital, School of Medicine, Zhejiang University

Central Contacts

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Zhi-wei WANG, Ph.D and MD.

Role: CONTACT

Phone: 0571-87783759

Email: [email protected]

References

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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.

Reference Type RESULT
PMID: 13287061 (View on PubMed)

Oster 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.

Reference Type RESULT
PMID: 32205705 (View on PubMed)

Kwon 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.

Reference Type RESULT
PMID: 35125463 (View on PubMed)

Park 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.

Reference Type RESULT
PMID: 31542473 (View on PubMed)

Lightsey 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.

Reference Type RESULT
PMID: 35125462 (View on PubMed)

Heo 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.

Reference Type RESULT
PMID: 31042664 (View on PubMed)

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/31042664

Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis

http://www.ncbi.nlm.nih.gov/pubmed/35125462

ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures

http://www.ncbi.nlm.nih.gov/pubmed/31542473

Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial

Other Identifiers

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UBE vs. MIS-TLIF

Identifier Type: -

Identifier Source: org_study_id