A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
Primary Purpose
Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
surgical treatment for lumbar spondylolisthesis
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spondylolisthesis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
UBE
MIS-TLIF
Arm Description
The patient treated with unilateral biportal endoscopy (UBE)
The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)
Outcomes
Primary Outcome Measures
ODI score
the D-value between the preoperative ODI score and 2-year-postoperative ODI score
Secondary Outcome Measures
Full Information
NCT ID
NCT05480267
First Posted
July 28, 2022
Last Updated
July 28, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05480267
Brief Title
A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
Official Title
Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
September 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, RenJi Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spondylolisthesis, Unilateral Biportal Endoscopy, Minimally Invasive Technique, Surgical Treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UBE
Arm Type
Experimental
Arm Description
The patient treated with unilateral biportal endoscopy (UBE)
Arm Title
MIS-TLIF
Arm Type
Active Comparator
Arm Description
The patient treated with classical minimally invasive posterior spinal interbody fusion (MIS-TLIF)
Intervention Type
Procedure
Intervention Name(s)
surgical treatment for lumbar spondylolisthesis
Intervention Description
There are two surgical treatments for lumbar spondylolisthesis; one is UBE, and another is MIS-TLIF
Primary Outcome Measure Information:
Title
ODI score
Description
the D-value between the preoperative ODI score and 2-year-postoperative ODI score
Time Frame
2 year postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhi-wei WANG, Ph.D and MD.
Phone
0571-87783759
Email
keyanlunli_zheer@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang CHEN, MD.
Organizational Affiliation
2nd hospital, School of Medicine, Zhejiang University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We have not decided when to share the plan. We plan to share it after the study completion.
Citations:
PubMed Identifier
13287061
Citation
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.
Results Reference
result
PubMed Identifier
32205705
Citation
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.
Results Reference
result
PubMed Identifier
35125463
Citation
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.
Results Reference
result
PubMed Identifier
31542473
Citation
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.
Results Reference
result
PubMed Identifier
35125462
Citation
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.
Results Reference
result
PubMed Identifier
31042664
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/31042664
Description
Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis
URL
http://www.ncbi.nlm.nih.gov/pubmed/35125462
Description
ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures
URL
http://www.ncbi.nlm.nih.gov/pubmed/31542473
Description
Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial
Learn more about this trial
A RCT of UBE vs. MIS-TLIF in Lumbar Spondylolisthesis
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