NCT06029764

Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 126 (estimated)
• Sponsor: Xuanwu Hospital, Beijing · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study was to validate the clinical effectiveness of interbody fusion with a one-segment extension for the treatment of adjacent segmental space discs in the surgical treatment of lumbar degeneration.

Detailed description

The study will include patients with lumbar degeneration who underwent 1-2 segment interbody fusion, and for patients with vacuum signs but no symptoms and no instability of the discs in the adjacent segments of the operated segments, lumbar interbody fusion will be extended by one segment, and the patients will be followed up annually in the immediate postoperative period, in March, June, and in the period of 1-5 years, and lumbar MR will be taken at the time of follow-up to determine the degree of progression of the degeneration in the neighboring segments, and whether or not revision surgery is needed. The lumbar spine was photographed in the frontal and lateral + anterior flexion and posterior extension X-rays and CT-3D reconstruction to determine the bony fusion of the interbody fusion. In addition, the lumbar spine ODI score was applied for evaluation at the follow-up visit, and the total lumbar spine-related expenses of the patients up to the follow-up visit were recorded.

Conditions

• Adjacent Segment Degeneration

Interventions

Type	Name	Description
PROCEDURE	extended one-level interbody fusion	For patients who have vacuum signs in the intervertebral disc adjacent to the surgical segment but are asymptomatic and not unstable, the intervertebral fusion surgery is extended to one segment and followed up immediately after surgery, 3 months, 6 months, and annually within 1 to 5 years. Take lumbar spine MR to determine the degree of degeneration progression of adjacent segments and whether revision surgery is needed. Take X-rays of the lumbar spine in frontal and lateral + flexion and extension positions, and CT-three-dimensional reconstruction to judge the bony fusion of the intervertebral fusion.

Timeline

• Start date: 2023-02-01
• Primary completion: 2028-01-01
• Completion: 2029-01-01
• First posted: 2023-09-08
• Last updated: 2023-09-08

Locations

1 site across 1 country: China