NCT05023733

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 27, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 28, 2022

Status Verified

January 1, 2022

Enrollment Period

3.4 years

First QC Date

August 16, 2021

Last Update Submit

January 14, 2022

Conditions

Foraminal StenosisDegenerative Disc DiseaseLumbar SpondylolisthesisLumbar Spinal Stenosis

Keywords

transforaminaldegenerative disc disease (DDD)Lumbar FusionInterbody Fusion

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • Back and Leg Visual Analog Scale (VAS)

    6 months

  • Back and Leg Visual Analog Scale (VAS)

    12 months

  • Back and Leg Visual Analog Scale

    18 months

  • Oswestry Disability Index (ODI)

    6 months

  • Oswestry Disability Index (ODI)

    12 months

  • +3 more secondary outcomes

Study Arms (1)

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®

Interventions

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

Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1

Also known as: lumbar fusion
1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, 06106, United States

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpondylolisthesisSpinal Stenosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesSpondylolysisSpondylosis

Study Officials

  • Farhan Karim, DO

    Hartford Hospital; Hartford Healthcare Bone & Joint Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany Samperi

CONTACT

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

Matthew Solomito, PhD

CONTACT

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Spine Surgeon

Study Record Dates

First Submitted

August 16, 2021

First Posted

August 27, 2021

Study Start

October 1, 2021

Primary Completion

March 1, 2025

Study Completion

October 1, 2025

Last Updated

January 28, 2022

Record last verified: 2022-01

Locations

US(1)