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Prospective, Observational Study of Anterior Bridging Cage Augmented With Bone Substitute Versus Localized Autobone in Transforaminal Lumbar Interbody Arthrodesis
The purpose of this study is to evaluation for the pattern of bone bridging of patients who undergo transforaminal lumbar interbody arthrodesis, the investigators hypothesize that auto local bone mixed with β-calcium phosphate + hydroxyapatite (OSTEON 2, Genoss) is not inferior to auto local bone only. In addition, the investigators will analyze anterior new bone bridging pattern between anterior bridging cage newly developed and grafted bone in anterior disc space.
A single center, observational, single arm study to evaluate the efficacy of auto local bone mixed with β-calcium phosphate + hydroxyapatite using interbody fusion assessment on multi-axial CT scan. Its active comparator is auto local bone. 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.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
Yes
Kwang Sup Song
Seoul, South Korea
Start Date
March 1, 2015
Primary Completion Date
April 1, 2019
Completion Date
June 1, 2019
Last Updated
December 8, 2021
69
ACTUAL participants
transforaminal lumbar interbody arthrodesis
PROCEDURE
Lead Sponsor
Zenoss Co, Ltd
NCT04992572
NCT07477002
NCT07474935
Data Source & Attribution
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