Preventive treatment for adjacent segment issues after lumbar fusion surgery
Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional Study
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04469387 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with unstable adjacent segments, significant spinal imbalance, infections, tumors, or prior lumbar fusion surgeries may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Beijing, Beijing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.