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

Farhan Karim

Status: Enrolling

Conditions: Degenerative Disc Disease; Foraminal Stenosis; Lumbar Spinal Stenosis; Lumbar Spondylolisthesis

Treatments: Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05023733

HHC-2020-0243

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No 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

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

Trial design

150 participants in 1 patient group

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

Description:

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.

Treatment:

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