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.
Study Type
OBSERVATIONAL
Enrollment
150
Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1
Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, United States
RECRUITINGRadiographic 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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