Risk factors of adjacent segment disease requiring surgery after lumbar spinal fusion: comparison of posterior lumbar interbody fusion and posterolateral fusion.
Jae Chul Lee, Yongdai Kim, Jae-Wan Soh...
https://pubmed.ncbi.nlm.nih.gov/24365899Actively Recruiting
Age: 18Years - 80Years
All Genders
ID04467944
Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery: a Prospective Cohort Study
Led by Peking University Third Hospital · Updated on 2020-07-13
210
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of pre-existing degeneration in adjacent spinal segments on long-term outcomes after lumbar fusion surgery for degenerative lumbar spinal stenosis and disc disease. This prospective study focuses on patients undergoing posterior lumbar interbody fusion (PLIF) at specific spinal levels (L4-5 and L5-S1) and investigates how factors like disc degeneration and spinal canal stenosis may influence postoperative recovery and complications such as adjacent segment degeneration (ASDeg) and disease (ASDis). Participants are grouped based on the condition of the adjacent L3/4 segment before surgery: those without degeneration (control group), those with disc degeneration factors, and those with spinal canal stenosis factors. Before surgery, they undergo imaging including dynamic X-rays and MRI scans to assess spinal conditions using specific grading systems. Surgical details, complications, and clinical function scores are collected. Follow-up assessments occur at 1, 2, and 5 years after surgery to monitor clinical outcomes and spinal segment changes. During the study, patients complete questionnaires measuring pain and disability levels, while imaging tests evaluate spinal changes over time. The primary outcomes include tracking adjacent segment degeneration and disease up to 10 years after surgery. Secondary outcomes focus on disability and pain in the back and legs at multiple time points. This long-term follow-up aims to better understand factors influencing recovery and potential needs for additional surgery.
CONDITIONS
Brief Title
Effect of Pre-existing Adjacent Segment Degeneration on Long-term Effectiveness After Lumbar Fusion Surgery
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years
- Clear diagnosis of lumbar spinal stenosis with surgical levels at L4 to S1
- Failed at least eight weeks of conservative treatment
You will not qualify if you...
- Unstable factors such as slip, rotation, or lateral bending in adjacent segment L3/4
- Preoperative sagittal and coronal imbalance of the spine
- Lumbar infection or tumor diseases
- Previous history of lumbar fusion surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration
Participants undergo lumbar fusion surgery at levels L4-5 and L5-S1 with preoperative imaging evaluations to assess adjacent segment degeneration.
1 hospitalization period including surgery
Long-term Monitoring
Duration - Up to 10 years
Participants are followed for up to 10 years after surgery to monitor adjacent segment degeneration and disease as well as clinical outcomes including pain and disability.
Follow-up visits at 1, 2, and 5 years post-surgery
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
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Research Team
Z
Zhuo Ran Sun, Dr.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Predicting the risk of adjacent segment pathology after lumbar fusion: a systematic review.
Brandon D Lawrence, Jeff Wang, Paul M Arnold...
https://pubmed.ncbi.nlm.nih.gov/22885827Risk factors for adjacent segment pathology requiring additional surgery after single-level spinal fusion: impact of pre-existing spinal stenosis demonstrated by preoperative myelography.
Itaru Yugué, Seiji Okada, Muneaki Masuda...
https://pubmed.ncbi.nlm.nih.gov/26272373A new grading system of lumbar central canal stenosis on MRI: an easy and reliable method.
Guen Young Lee, Joon Woo Lee, Hee Seok Choi...
https://pubmed.ncbi.nlm.nih.gov/21286714MSU classification for herniated lumbar discs on MRI: toward developing objective criteria for surgical selection.
Lawrence Walter Mysliwiec, Jacek Cholewicki, Michael D Winkelpleck...
https://pubmed.ncbi.nlm.nih.gov/20084410Adjacent Segment Disease After Posterior Lumbar Interbody Fusion: Based on Cases With a Minimum of 10 Years of Follow-up.
Hiroaki Nakashima, Noriaki Kawakami, Taichi Tsuji...
https://pubmed.ncbi.nlm.nih.gov/25839385