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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05023733
• Other study ID #: HHC-2020-0243
• Status: Recruiting
• Start date: October 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: January 2022
• Source: Hartford Hospital
• Contact: Bethany Samperi
• Phone: 860-972-5978
• Email: bethany.samperi[@]hhchealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Disc Disease
• Foraminal Stenosis
• Intervertebral Disc Degeneration
• Lumbar Spinal Stenosis
• Lumbar Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

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

Locations

Country	Name	City	State
United States	Hartford Healthcare Bone and Joint Institute	Hartford	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Farhan Karim	DePuy Synthes

Country where clinical trial is conducted

United States, 

Outcome

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