Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant (NCT05023733) | Clinical Trial Compass
UnknownNot Applicable
Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant
United States150 participantsStarted 2021-10-01
Plain-language summary
This study is designed to evaluate clinical outcomes and spine fusion rates for patients undergoing transforaminal lumbar interbody fusion using the CONDUIT 3D printed titanium TLIF cage.
Who can participate
Age range35 Years ā 80 Years
SexALL
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Inclusion Criteria:
* Skeletally mature adults ages 35 - 80 years of age, inclusive
* Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis
* Subject undergoing one or two level transforaminal lumbar interbody fusion
* Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires
Exclusion Criteria:
* Patients over 80 years of age
* Patients under 35 years of age
* Current smokers
* BMI\>42
* Subject has spondylolisthesis \> 2
* Subjects with multilevel \>2 levels of symptomatic disease
* Subjects with significant spinal deformity
* Subject is pregnant, plans to become pregnant or is breast feeding