Anterior Bridging Cage With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
NCT ID: NCT02485574
Last Updated: 2021-12-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
69 participants
INTERVENTIONAL
2015-03-31
2019-06-30
Brief Summary
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Detailed Description
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Anterior bridging bone between anterior grafted bone and inserted cage will be assessed by using newly developed anterior bridging cage as well as interbody bone bridging between two vertebral bodies on multi-axial reconstructed CT scan.
The patients undergoes arthrodesis surgery will have two cages, one augmented with auto local bone will be located at left side of disc space and the other cage augmented with auto local bone mixed with β-calcium phosphate + hydroxyapatite at right side of disc space.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Left cage- auto bone
At the operated segment, left cage was filled with auto bone only. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.
transforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Right cage- auto local bone mixed with β-calcium phosphate + hydroxyapatite
At the operated segment, right cage was filled with auto local bone mixed with β-calcium phosphate + hydroxyapatite. We evaluated bone bridging between inside and outside the cage in transforaminal lumbar interbody arthrodesis.
transforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Interventions
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transforaminal lumbar interbody arthrodesis
Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in right side of disc space and anterior bridging cages augmented with auto bone in left side of disc space in transforaminal lumbar interbody arthrodesis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who have no communication problems
* Patients who are willing to visit the hospital for any follow-up assessment
* Patients who voluntarily sign on a written consent
Exclusion Criteria
* Patients who have bleeding disorders
* Patients who have immunosuppressed disease
* Patients who can't sign on consent form
* Patients who are in pregnancy or breast feeding
* Patients who have severe osteoporosis
* Patients who can't take general surgery because of severe liver disease or decreased renal function
* Patients who have acute spinal injury, spinal tumor or inflammatory spinal disease
18 Years
80 Years
ALL
Yes
Sponsors
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Zenoss Co, Ltd
OTHER
Responsible Party
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Kwang Sup Song
Professor
Principal Investigators
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Kwang Sup Song, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University
Locations
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Kwang Sup Song
Seoul, , South Korea
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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KSong
Identifier Type: -
Identifier Source: org_study_id