Status:
RECRUITING
Preventive Effect of Limited Decompression on Adjacent Segment Following Posterior Lumbar Interbody Fusion
Lead Sponsor:
Peking University Third Hospital
Conditions:
Degenerative Lumbar Spinal Stenosis
Degenerative Disc Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a prospective single-center study. Patients requiring posterior lumbar interbody fusion (PLIF) for degenerative disease are prospectively enrolled and followed. Patients enrolled in this study...
Detailed Description
Adjacent segment pathologies (ASP), including radiological adjacent segment degeneration (ASDeg) and adjacent segment disease (ASDis) after lumbar fusion surgeries have been troubling complications. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2032
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04469387
Start Date
September 1 2020
End Date
August 1 2032
Last Update
September 18 2020
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191