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

Recruiting

• Conditions: Lumbar Spondylolisthesis; Lumbar Spinal Stenosis; Foraminal Stenosis; Degenerative Disc Disease
• Interventions: Device: CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®

• Registration Number: NCT05023733
• Lead Sponsor: Farhan Karim

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.

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 Timeline

• Study First Submitted: 2021-08-16
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Study Start: 2021-10-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-28
• Primary Completion: 2025-03-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1	CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Back and Leg Visual Analog Scale (VAS)	12 months	Improvement in the VAS as measured by a minimum of a 20 point improvement
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)
Oswestry Disability Index (ODI)	18 months	Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) \>20%
Back and Leg Visual Analog Scale	18 months	Improvement in the VAS as measured by a minimum of a 20 point improvement

Trial Locations

Locations (1)

Hartford Healthcare Bone and Joint Institute; 🇺🇸 Hartford, Connecticut, United States