NCT05023733

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Farhan Karim · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Foraminal Stenosis
• Degenerative Disc Disease
• Lumbar Spondylolisthesis
• Lumbar Spinal Stenosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-10-01
• Primary completion: 2025-03-01
• Completion: 2025-10-01
• First posted: 2021-08-27
• Last updated: 2022-01-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study