Status:
UNKNOWN
3D-printed Porous Titanium Alloy Cages Versus PEEK Cages in Patients With Osteoporosis
Lead Sponsor:
Peking University Third Hospital
Conditions:
Osteoporosis
Degenerative Disc Disease
Eligibility:
All Genders
50+ years
Brief Summary
This is a prospective,observational single-center study. The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled ...
Detailed Description
Pedicle screw fixation is a widely used technique for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine before solid fusion and restore spinal balance. However, bec...
Eligibility Criteria
Inclusion
- aged≥ 50 years old
- lumbar degenerative diseases requiring lumbar fusion with pedicle screw fixation, such as degenerative lumbar spinal stenosis, degenerative lumbar spondylolisthesis.
- no response to nonoperative treatment of at least 3 months
- osteoporosis diagnosed by any method for bone mineral density evaluation, such as DXA, QCT，or vertebral Hounsfield units
- the lowest instrumented vertebrae were at L5 or S1
- the surgical plan includes lumbar interbody fusion with cages at the lowest fusion level
- informed consent
Exclusion
- the surgical plan includes any techniques used to strengthen the fixation,such as augmentation of the pedicle screw with bone cement
- no lumbar CT scans within 3 months before the surgery
- no dual energy x-ray absorptiometry within 6 months before the surgery
- spondylolysis
- allergic to metal
- history of lumbar fusion surgery
- cervical myelopathy，thoracic spinal stenosis, motor neuron disease,tuberculosis of spine,spinal tumor
Key Trial Info
Start Date :
January 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04086784
Start Date
January 15 2020
End Date
December 31 2022
Last Update
September 17 2021
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191