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/22885827Actively Recruiting
Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID04469387
Preventive Effect of Limited Decompression on Adjacent Segment With Pre-existing Spinal Canal Stenosis Following Posterior Lumbar Interbody Fusion: a Prospective Interventional Study
Led by Peking University Third Hospital · Updated on 2020-09-18
200
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the preventive effect of limited decompression at an adjacent spinal segment in patients undergoing posterior lumbar interbody fusion (PLIF) for degenerative lumbar spinal stenosis and related spine degeneration. This prospective, single-center interventional study focuses on patients with asymptomatic pre-existing spinal canal stenosis at the adjacent L3/4 segment. The aim is to understand if limited decompression can reduce the risk of adjacent segment pathology, which includes degeneration and disease that may reduce quality of life and require additional surgery. Participants are randomly assigned to one of two groups. The NS Group receives fusion surgery at the responsible segments L4-S1 without additional decompression, while the LD Group undergoes the same fusion plus limited decompression at the adjacent L3/4 segment. Limited decompression involves partial laminotomy, flavectomy, and bilateral medial facetectomies, avoiding complete laminectomy and damage to the posterior ligament complex. The fusion technique is consistent across patients using PLIF at L4-5 and L5-S1. During the study, patients are monitored with imaging tests including dynamic X-rays and MRI before surgery to assess spine condition. Clinical function is tracked with questionnaires measuring pain and disability before surgery and at 1, 2, 5, and 10 years after surgery. Surgical data such as operation time, blood loss, complications, and hospital stay are recorded. The main outcomes measured are adjacent segment degeneration and disease over a 10-year follow-up, along with assessments of disability, back pain, and leg pain at several time points post-surgery.
CONDITIONS
Brief Title
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- A clear diagnosis of lumbar spinal stenosis with surgical levels at L4-S1
- Presence of asymptomatic pre-existing spinal canal stenosis (cerebrospinal fluid occlusion grade=1) at the adjacent segment
- Failure of at least eight weeks of conservative treatment
You will not qualify if you...
- Unstable factors (such as slip, rotation, lateral bending) in the adjacent L3/4 segment
- 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) for evaluation of lumbar imaging and clinical assessment
Treatment
Duration - Hospital stay for surgery and immediate recovery period
Participants undergo posterior lumbar interbody fusion surgery at segments L4-5 and L5-S1. Some participants also receive limited decompression at the adjacent segment L3/4 to prevent adjacent segment pathology.
1 surgical hospital stay with post-operative monitoring
Follow-up
Duration - Up to 10 years after surgery
Participants complete follow-up visits to assess clinical outcomes including adjacent segment degeneration, disability, back pain, and leg pain.
Follow-up visits at 1, 2, 5, and 10 years post-surgery
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Actively Recruiting
Loading map...
Research Team
Z
Zhuo Ran Sun, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Adjacent segment disease after instrumented fusion for adult lumbar spondylolisthesis: Incidence and risk factors.
Zhao-Ming Zhong, Vedat Deviren, Bobby Tay...
https://pubmed.ncbi.nlm.nih.gov/28288396Predisposing Characteristics of Adjacent Segment Disease After Lumbar Fusion.
Vincent J Alentado, Daniel Lubelski, Andrew T Healy...
https://pubmed.ncbi.nlm.nih.gov/26863261Risk factors for adjacent segment disease after posterior lumbar interbody fusion and efficacy of simultaneous decompression surgery for symptomatic adjacent segment disease.
Tomohiro Hikata, Michihiro Kamata, Mitsuru Furukawa
https://pubmed.ncbi.nlm.nih.gov/22460400Effects of Concomitant Decompression Adjacent to a Posterior Lumbar Interbody Fusion Segment on Clinical and Radiologic Outcomes: Comparative Analysis 5 Years After Surgery.
Tomiya Matsumoto, Shinya Okuda, Yukitaka Nagamoto...
https://pubmed.ncbi.nlm.nih.gov/31431873A 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/21286714Adjacent 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