An observational study in Foraminal Stenosis, Degenerative Disc Disease and Lumbar Spondylolisthesis, sponsored by Farhan Karim. Status unknown at 1 site in United States. Open to participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Farhan Karim · Observational
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.
This prospective, single-center study is being conducted as a post market evaluation of the CONDUIT 3D printed titanium TLIF Cage. Patients undergoing transforaminal lumbar interbody fusions due to lumbar spinal pathology (i.e. central foraminal stenosis, degenerative disc disease, and/or lumbar spondylolisthesis) and have failed conservative care will be recruited for this study. Patients will be serially evaluated at 6 month intervals for a total of 24 months post index procedure to assess patient reported outcomes, clinical outcomes, and radiographic parameter, specifically spine fusion rates.
472 studies on the registry are indexed under Intervertebral Disc Degeneration; 100 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 167 observational studies indexed under Intervertebral Disc Degeneration.
Browse Intervertebral Disc Degeneration studies →This is the only study on the registry with Farhan Karim as lead sponsor.
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Patients will be skeletally mature adults ages 35-80 years of age undergoing one or two level transforaminal lumbar interbody fusion. These patients will have a diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral /bilateral foraminal stenosis.
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Exclusion Criteria:
One to two contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 whose condition requires the use of interbody fusion.
Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®
Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1
Also known as: lumbar fusion
Radiographic Fusion
Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 18 months
Time frame: 18 months
Radiographic Fusion
Fusion success measured by radiological assessment. Evidence of fusion demonstrated by bone formation through the cage on anteroposterior (AP) and Lateral radiographs, Flexion and Extension radiographs at 24 months
Time frame: 24 months
Back and Leg Visual Analog Scale (VAS)
Improvement in the VAS as measured by a minimum of a 20 point improvement
Time frame: 6 months
Back and Leg Visual Analog Scale (VAS)
Improvement in the VAS as measured by a minimum of a 20 point improvement
Time frame: 12 months
Back and Leg Visual Analog Scale
Improvement in the VAS as measured by a minimum of a 20 point improvement
Time frame: 18 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \>20%
Time frame: 6 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \>20%
Time frame: 12 months
Oswestry Disability Index (ODI)
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \>20%
Time frame: 18 months
Adverse Events
Number of procedure and device related adverse events
Time frame: up to 24 months
Intervention Rates
Rates of reoperation and/or revision procedures at index level(s)
Time frame: up to 24 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Intervertebral Disc Degeneration →