Impact of pre-existing degeneration on outcomes after lumbar fusion surgery
Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study
Peking University Third Hospital · NCT04467944
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 |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital (other) |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04467944 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with lumbar spinal stenosis who have not responded to at least eight weeks of conservative treatment.
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 study could enhance postoperative outcomes and quality of life for patients undergoing lumbar fusion surgery.
How similar studies have performed: While some studies have explored adjacent segment degeneration, this study's specific focus on asymptomatic pre-existing conditions represents a novel approach.
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); * 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.
Conditions: Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degeneration Spine, Cerebrospinal fluid occlusion, Pre-existing degeneration, Spinal canal stenosis, Adjacent segment degeneration, Adjacent segment disease