Recruiting

TLIF with 3D Printed Implant

Sponsor:

Farhan Karim

Code:

NCT05023733

Conditions

Foraminal Stenosis

Degenerative Disc Disease

Lumbar Spondylolisthesis

Lumbar Spinal Stenosis

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Foraminal Stenosis

Degenerative Disc Disease

Lumbar Spondylolisthesis

Lumbar Spinal Stenosis

Study ID

NCT05023733

Start date

Oct 1, 2021

Status verified date

Jan, 2022

Completion date

Oct 1, 2025

Anticipated

Primary completion date

Mar 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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

Primary outcome measure

  • Radiographic Fusion [ Time Frame: 18 months ]
  • Radiographic Fusion [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Bethany Samperi

860-972-5978bethany.samperi@hhchealth.org

Matthew Solomito, PhD

203-525-7659matthew.solomito@hhchealth.org

Locations

Hartford Healthcare Bone and Joint Institute

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Bethany Samperi

860-972-5978bethany.samperi@hhchealth.org

Matthew Solomito, PhD

203-525-7659matthew.solomito@hhchealth.org

Principal Investigator:

Farhan Karim, DO

More Information

Sponsor

Farhan Karim

Last update posted

Jan 28, 2022

Last verified

Jan, 2022

Keywords

  • transforaminal
  • degenerative disc disease (DDD)
  • Lumbar Fusion
  • Interbody Fusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Farhan Karim on 2022-01-28.