Status:
ENROLLING_BY_INVITATION
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
Lead Sponsor:
Peking University Third Hospital
Conditions:
Osteoporosis
Degenerative Lumbar Disease
Eligibility:
All Genders
50+ years
Brief Summary
This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up. The patients undergoi...
Detailed Description
Interbody fusion cages are widely used for the surgical treatment of degenerative lumbar diseases, which can stabilize the spine and promote solid fusion. However, because of population aging and the ...
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, QCTor CT Hounsfield units
- requiring lumbar interbody fusion with cages within L3-S1
- the type of fusion cage has been chosen by the patients
- informed consent
Exclusion
- the surgical plan includes any unconventional techniques used to strengthen the fixation, such as augmentation of the pedicle screw with bone cement
- lumbar spondylolisthesis of ≥II degree
- lumbar scoliosis of \>20° or imbalance of spinal alignment
- history of lumbar fusion surgery
- cervical myelopathy, thoracic spinal stenosis, motor neuron disease,tuberculosis of spine,spinal tumor
- vertebral fracture within interbody fusion segement
- ASA of ≥IV
Key Trial Info
Start Date :
August 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05981222
Start Date
August 1 2023
End Date
August 1 2027
Last Update
January 22 2025
Active Locations (1)
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1
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191