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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Bethany Samperi; Phone Number: 860-972-5978; Email: bethany.samperi@hhchealth.org
• Study Contact Backup: Name: Matthew Solomito, PhD; Phone Number: 203-525-7659; Email: matthew.solomito@hhchealth.org

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Healthcare Bone and Joint Institute
      • Contact: Bethany Samperi; Phone Number: 860-972-5978; Email: bethany.samperi@hhchealth.org
      • Contact: Matthew Solomito, PhD; Phone Number: 203-525-7659; Email: matthew.solomito@hhchealth.org
      • Principal Investigator: Farhan Karim, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients will be skeletally mature adults ages 35-80 years of age undergoing one or two level transforaminal lumbar interbody fusion. These patients will have a diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral /bilateral foraminal stenosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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; Other Names: lumbar fusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Farhan Karim
• Collaborators: DePuy Synthes
• Investigators: Principal Investigator: Farhan Karim, DO, Hartford Hospital; Hartford Healthcare Bone & Joint Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2021
• Primary Completion (ANTICIPATED): March 1, 2025
• Study Completion (ANTICIPATED): October 1, 2025

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (ACTUAL): August 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Interbody Fusion; Lumbar Fusion; transforaminal; degenerative disc disease (DDD)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Intervertebral Disc Degeneration; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: HHC-2020-0243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes