Clinical and Radiographic Outcomes of TLIF w/3D Printed Cellular Implant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant

Conditions
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Foraminal Stenosis, Degenerative Disc Disease, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis

Intervention / Treatment
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* Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1<br>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®<br>* Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1<br>* Other names: lumbar fusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Back and Leg Visual Analog Scale (VAS) | Improvement in the VAS as measured by a minimum of a 20 point improvement | 6 months | 
| Back and Leg Visual Analog Scale (VAS) | Improvement in the VAS as measured by a minimum of a 20 point improvement | 12 months | 
| Back and Leg Visual Analog Scale | Improvement in the VAS as measured by a minimum of a 20 point improvement | 18 months | 
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 6 months | 
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 12 months | 
| Oswestry Disability Index (ODI) | Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20% | 18 months | 
| Adverse Events | Number of procedure and device related adverse events | up to 24 months | 
| Intervention Rates | Rates of reoperation and/or revision procedures at index level(s) | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transforaminal, degenerative disc disease (DDD), Lumbar Fusion, Interbody Fusion