Ignite Creation Date:
2024-05-06 @ 7:22 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05981222
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-08-08
First Post:
2023-08-01
Brief Title:
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
Biomechanical-matched Titanium CagesOsteo Match Versus PEEK Cages in Osteoporotic Lumbar Spine a Multicenter Prospective Cohort Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OMC
Brief Summary:
This is a multicenter prospective cohort study The osteoporotic patients requiring posterior lumbar interbody fusionLIF with cages are prospectively enrolled and followed up The patients undergoing LIF with the biomechanical-matched 3D-printed titanium cages Osteo Match are compared with those using routine PEEK cages The hypothesis is that the use of Osteo Match cages can reduce the rate of cage subsidence and increase the rate of lumbar fusion in osteoporotic patients
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 high rate of osteoporosis in the elderly with lumbar degenerative diseases the cage subsidence and failure of fusion have been frequently reported The biomechanical strength such as elasticity modulus of routine PEEK cages is mismatched with osteoporotic bone leading to cage subsidence and nonunion
The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up and enhancing the lumbar fusion over conventional PEEK cages However most of the titanium cages still have much higher biomechanical strength than the osteoporotic bone The new titanium cages named Osteo Match has been first clinically used in Peking University Third Hospital in China The elastic modulus of Osteo Match cage is matched with that of lumbar spine with different degrees of osteoporosis Therefore we hypothesize that patients undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher rate of lumbar fusion than those using PEEK cages
The osteoporotic patients requiring posterior lumbar interbody fusion with cages are prospectively enrolled and followed up The researchers will invite appropriate patients to participate in the study after their surgical plans are determined General patients data are collected after informed consent such as age gender weight height bone mineral density measured by DXA CT Hounsfield units or QCT detailed surgical plans and etc They are followed up at 3 6 12 and 24 months according to our clinical routine including lumbar x-ray CTand certain questions about the clinical outcomes
The patients used Osteo Match cages are compared with those using conventional PEEK cages The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up The secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up and the clinical outcomesODIJOAVAS at every follow-up
The 3D-printed porous titanium alloy cages have been proved to have advantages in speeding up and enhancing the lumbar fusion over conventional PEEK cages However most of the titanium cages still have much higher biomechanical strength than the osteoporotic bone The new titanium cages named Osteo Match has been first clinically used in Peking University Third Hospital in China The elastic modulus of Osteo Match cage is matched with that of lumbar spine with different degrees of osteoporosis Therefore we hypothesize that patients undergoing LIF with Osteo Match cages can achieve lower rate of cage subsidence and higher rate of lumbar fusion than those using PEEK cages
The osteoporotic patients requiring posterior lumbar interbody fusion with cages are prospectively enrolled and followed up The researchers will invite appropriate patients to participate in the study after their surgical plans are determined General patients data are collected after informed consent such as age gender weight height bone mineral density measured by DXA CT Hounsfield units or QCT detailed surgical plans and etc They are followed up at 3 6 12 and 24 months according to our clinical routine including lumbar x-ray CTand certain questions about the clinical outcomes
The patients used Osteo Match cages are compared with those using conventional PEEK cages The primary endpoints are the subsidence rate and fusion rate at 6 months follow-up The secondary endpoints are the subsidence rate and fusion rate at other time point of follow-up and the clinical outcomesODIJOAVAS at every follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None