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

Lumbar Spondylolisthesis Clinical Trial

Official title:

Unilateral Biportal Endoscopy Versus MIS-TLIF in Lumbar Spondylolisthesis: A Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05480267
• Other study ID #: UBE vs. MIS-TLIF
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2025

Study information

• Verified date: July 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Zhi-wei WANG, Ph.D and MD.
• Phone: 0571-87783759
• Email: keyanlunli_zheer[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 340
• Est. completion date: September 1, 2025
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Spondylolisthesis
• Spondylolisthesis
• Surgical Treatment

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	RenJi Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

References & Publications (6)

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.FOCU — View 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 — View 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 A — View Citation

MUTCH J, WALMSLEY R. The aetiology of cleft vertebral arch in spondylolisthesis. Lancet. 1956 Jan 14;270(6907):74-7. — View 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. — View 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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ODI score	the D-value between the preoperative ODI score and 2-year-postoperative ODI score	2 year postoperatively

External Links

•   ALIF Demonstrates Superior Segmental and Regional Radiographic Outcomes and Clinical Improvements Across More Patient-reported Outcome Measures
•   Biportal endoscopic versus microscopic lumbar decompressive laminectomy in patients with spinal stenosis: a randomized controlled trial
•   Comparative analysis of three types of minimally invasive decompressive surgery for lumbar central stenosis