Multicenter Clinical Randomized Controlled Trial of Unilateral Biportal Endoscopic Spinal Surgery for Degenerative Grade 1 Spondylolisthesis Complicated With Lumbar Spinal Stenosis

NCT07303348 | Active Not Recruiting DMC

• 1 other identifier: SPINE-UBE
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The research objective of this project is to clarify and compare the efficacy of the unilateral biportal endoscopy (UBE) technique and traditional open decompression, fusion and internal fixation surgery in the treatment of patients with Grade Ⅰ degenerative spondylolisthesis complicated with central spinal canal stenosis through high-quality, prospective, multicenter randomized controlled trials (RCTs), so as to provide high-level clinical research evidence for the expansion of UBE technique indications and its technical promotion.

Conditions

Lumbar Spinal Stenosis (LSS); Degenerative Spondylolisthesis G1

Keywords

Grade Ⅰ degenerative spondylolisthesis; lumbar spinal stenosis

Outcome Measures

Primary Outcomes (1)

• VAS

  Status of Visual Analog Scale (VAS) Scores in Two Groups of Patients at 24 Months Postoperatively

  24 months after surgery

Study Arms (2)

Perform surgery using the Unilateral Biportal Endoscopy (UBE) technique

EXPERIMENTAL

inclusion Criteria Single-segment Grade Ⅰ lumbar spondylolisthesis complicated with central spinal canal stenosis on imaging examinations; Accompanied by intermittent claudication, radiating pain and numbness of the lower extremities, and other relevant neurological symptoms; No relief of symptoms after more than 3 months of conservative treatment; The patient and their family members are fully informed of the trial details, have signed the informed consent form, and agree to participate in the trial. Exclusion Criteria Lumbar spondylolisthesis of Grade Ⅱ or higher; Non-degenerative lumbar spine diseases, or significant confirmed lumbar instability; Complicated with lumbar spine infection, tumor, trauma, or deformity; or with a history of previous lumbar spine surgery; Complicated with other systemic diseases that may significantly affect surgical efficacy (such as rheumatoid arthritis, severe osteoporosis, and severe mental illness).

Procedure: UBE

PLIF/TLIF

ACTIVE COMPARATOR

inclusion Criteria Single-segment Grade Ⅰ lumbar spondylolisthesis complicated with central spinal canal stenosis on imaging examinations; Accompanied by intermittent claudication, radiating pain and numbness of the lower extremities, and other relevant neurological symptoms; No relief of symptoms after more than 3 months of conservative treatment; The patient and their family members are fully informed of the trial details, have signed the informed consent form, and agree to participate in the trial. Exclusion Criteria Lumbar spondylolisthesis of Grade Ⅱ or higher; Non-degenerative lumbar spine diseases, or significant confirmed lumbar instability; Complicated with lumbar spine infection, tumor, trauma, or deformity; or with a history of previous lumbar spine surgery; Complicated with other systemic diseases that may significantly affect surgical efficacy (such as rheumatoid arthritis, severe osteoporosis, and severe mental illness).

Procedure: PLIF

Interventions

UBE PROCEDURE

Unilateral Biportal Endoscopy (UBE) for the treatment of lumbar spinal stenosis combines the advantages of both open surgery and minimally invasive surgery: ① Minimal surgical trauma: Only two small incisions of 0.8 cm are required, resulting in minimal damage to the paraspinal muscles; ② Aqueous medium surgical field: Radiofrequency can be used for effective and precise hemostasis under endoscopy, which significantly reduces blood loss; ③ Endoscopic operation: The surgical field is magnified, allowing clear and adequate exposure of the dura mater and nerves to avoid injury to important structural tissues; ④ Precise decompression: Under the above conditions, traditional surgical instruments and specialized tools such as endoscopic drills can be used to complete bilateral resection of the lamina and ligamentum flavum as well as spinal canal enlargement, achieving meticulous decompression of the central canal and lateral recess.

Perform surgery using the Unilateral Biportal Endoscopy (UBE) technique

PLIF PROCEDURE

Posterior Lumbar Interbody Fusion (PLIF) adopts a midline posterior lumbar approach. On the basis of completing decompression of the spinal canal and nerve root canal, it resects the intervertebral disc tissue of the pathological segment and implants bone grafts (or interbody fusion cages) to achieve intervertebral bony fusion. Meanwhile, it is combined with a pedicle screw internal fixation system to maintain spinal alignment and stability, ultimately aiming to relieve neurological symptoms and restore the mechanical function of the spine.

PLIF/TLIF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Changhai Hospital: lead
• Shanghai Changzheng Hospital: collaborator
• Shanghai Kaiyuan Orthopedic Hospital: collaborator
• Beijing Jishuitan Hospital: collaborator
• Guangzhou General Hospital of Guangzhou Military Command: collaborator
• Eastern Theater Command Naval Hospital: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)