Extended interbody fusion for lumbar disc degeneration
Official title: Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc Disease
Run by Xuanwu Hospital, Beijing · NCT06029764 · Data updated 2026-11-12
This study is testing if adding an extra fusion segment helps people with lumbar disc degeneration who have already had surgery feel better and avoid more surgery in the future.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | February 1, 2023 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2029 |
| Registry record updated | September 8, 2023 |
| Trial ID | NCT06029764 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18-60 with lumbar degeneration requiring 1-2 segment interbody fusion and vacuum signs in adjacent segments without symptoms.
✕Probably not a fit
Patients with significant instability in adjacent segments, severe comorbidities, or those unsuitable for surgery will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to validate the effectiveness of extending interbody fusion by one segment in patients with lumbar degeneration who have undergone 1-2 segment interbody fusion. It focuses on patients exhibiting vacuum signs in adjacent segments without symptoms or instability. Participants will be monitored annually post-surgery for up to five years, with imaging and clinical evaluations to assess degeneration progression and the need for revision surgery. The study will also track the overall costs related to lumbar spine treatment.
Why it matters
Potential benefit: If successful, this approach could improve outcomes for patients with adjacent segment degeneration and reduce the need for additional surgeries.
How similar studies have gone: While similar approaches have been explored, this specific extension of interbody fusion for adjacent vacuum phenomenon is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The age was between 18-60 years old; patients with lumbar degeneration required 1-2 segment interbody fusion, and there were vacuum signs but no symptoms and no instability of the discs in the adjacent segments (power position slip ≤3mm and segmental angle change ≤10°); they agreed with the surgical plan and were willing to undergo long-term clinical follow-up, and signed an informed consent form. Exclusion Criteria: * Drug or alcohol abusers; those with abnormal liver or kidney function unsuitable for surgery; those with cardiac insufficiency unsuitable for surgery; those with severe metabolic and endocrine diseases unsuitable for surgery; those with severe lung disorders such as asthma and abnormal lung function unsuitable for surgery; pregnant and breastfeeding women as well as those who are planning to become pregnant in the near future; those who have participated in other clinical trials within 3 months; and those who are not suitable for participation in the experiment in the opinion of the investigator.
Where it's running
-
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Hao Wu, MD,PhD
- Email: 13901397527@139.com
- Phone: 13901397527
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.