Impact of pre-existing degeneration on outcomes after lumbar fusion surgery
Official title: Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study
Run by Peking University Third Hospital · NCT04467944 · Data updated 2026-11-12
This study looks at how existing back problems affect recovery and quality of life for patients undergoing lumbar fusion surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | January 1, 2018 |
| Main results expected | December 31, 2022 |
| Study ends | December 31, 2032 |
| Registry record updated | July 13, 2020 |
| Trial ID | NCT04467944 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with lumbar spinal stenosis who have not responded to at least eight weeks of conservative treatment.
✕Probably not a fit
Patients with unstable adjacent segments, significant spinal imbalance, infections, tumors, or prior lumbar fusion surgeries may 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 observational study enrolls patients requiring posterior lumbar interbody fusion (PLIF) for degenerative lumbar conditions. It focuses on the influence of pre-existing adjacent segment degeneration factors, such as degenerated discs and spinal canal stenosis, on long-term postoperative outcomes. The study aims to identify how these factors affect the risk of adjacent segment disease and the overall quality of life post-surgery. By analyzing these pre-existing conditions, the research seeks to improve surgical strategies and patient management.
Why it matters
Potential benefit: If successful, this study could enhance postoperative outcomes and quality of life for patients undergoing lumbar fusion surgery.
How similar studies have gone: While some studies have explored adjacent segment degeneration, this study's specific focus on asymptomatic pre-existing conditions represents a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A clear diagnosis of lumbar spinal stenosis, and surgical level of L4- S1 (The levels to be operated on were decided by matching the clinical symptomatology with the radiological findings of the spinal levels that needed decompression); * Failed at least eight weeks conservative treatment; Exclusion Criteria: * Unstable factors (slip, rotation, lateral bending, etc.) in adjacent segment L3/4; * Preoperative sagittal and coronal imbalance of the spine; * Lumbar infection and/or tumor diseases; * A previous history of lumbar fusion surgery.
Where it's running
-
Peking University Third Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Wei Shi Li, Dr. — Peking University Third Hospital
- Study coordinator: Zhuo Ran Sun, Dr.
- Email: puh3_szr@outlook.com
- Phone: +8618610292513
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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The trial will test whether using Novosis Putty during transforaminal lumbar interbody fusion helps adults with lumbar degenerative disc disease heal better compared with standard care.
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This study is testing a new non-surgical treatment for people with painful disc degeneration to see if it can help relieve their back pain when other treatments haven't worked.
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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.