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

NCT06029764 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2023-09-08

No results posted yet for this study

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.

Conditions

  • Adjacent Segment Degeneration

Interventions

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.

Sponsors & Collaborators

  • Xuanwu Hospital, Beijing

    lead OTHER

Principal Investigators

  • Fengzeng Jian, MD,PhD · Xuanwu Hospital, Beijing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2028-01-01
Completion
2029-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06029764 on ClinicalTrials.gov