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

Sponsor

Farhan Karim (Other)

Overall Status

Recruiting

CT.gov ID

NCT05023733

Collaborator

DePuy Synthes (Industry)

150

Enrollment

Location

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Foraminal Stenosis Degenerative Disc Disease Lumbar Spondylolisthesis Lumbar Spinal Stenosis	Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Oct 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1 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 Other Names: lumbar fusion

Arm

Intervention/Treatment

1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1

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

Other Names:

lumbar fusion

Outcome Measures

Primary Outcome Measures

Radiographic Fusion [18 months]
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
Radiographic Fusion [24 months]
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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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