Preventive treatment for adjacent segment issues after lumbar fusion surgery
Official title: Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional Study
Run by Peking University Third Hospital · NCT04469387 · Data updated 2026-11-12
This study is testing whether a small surgery to relieve pressure on the spine can help prevent problems in nearby areas after people have lumbar fusion surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | September 1, 2020 |
| Main results expected | August 1, 2022 |
| Study ends | August 1, 2032 |
| Registry record updated | September 18, 2020 |
| Trial ID | NCT04469387 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients diagnosed with lumbar spinal stenosis requiring PLIF at the L4-S1 levels who have asymptomatic pre-existing spinal canal stenosis.
✕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 prospective study focuses on patients undergoing posterior lumbar interbody fusion (PLIF) for degenerative conditions who also have asymptomatic pre-existing spinal canal stenosis at adjacent segments. The research aims to evaluate the effects of limited decompression procedures, such as partial laminotomy and flavectomy, on preventing adjacent segment degeneration and disease. Patients will be monitored through dynamic X-ray and MRI examinations to assess the outcomes of the intervention. The study is designed to provide insights into the management of adjacent segment pathologies following lumbar fusion surgeries.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of adjacent segment degeneration and improve postoperative quality of life for patients.
How similar studies have gone: While adjacent segment degeneration is a known complication, this specific approach of limited decompression in asymptomatic patients is relatively novel and has not been extensively tested in prior studies.
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); * Patients have asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at adjacent segment. * 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
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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.