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

January 14, 2022 updated by: Farhan Karim

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic Fusion
Time Frame: 18 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 18 months
18 months
Radiographic Fusion
Time Frame: 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
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Back and Leg Visual Analog Scale (VAS)
Time Frame: 6 months
Improvement in the VAS as measured by a minimum of a 20 point improvement
6 months
Back and Leg Visual Analog Scale (VAS)
Time Frame: 12 months
Improvement in the VAS as measured by a minimum of a 20 point improvement
12 months
Back and Leg Visual Analog Scale
Time Frame: 18 months
Improvement in the VAS as measured by a minimum of a 20 point improvement
18 months
Oswestry Disability Index (ODI)
Time Frame: 6 months
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
6 months
Oswestry Disability Index (ODI)
Time Frame: 12 months
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
12 months
Oswestry Disability Index (ODI)
Time Frame: 18 months
Clinical Improvement will be defined by improvement in Oswestry Disability Index (ODI) >20%
18 months
Adverse Events
Time Frame: up to 24 months
Number of procedure and device related adverse events
up to 24 months
Intervention Rates
Time Frame: up to 24 months
Rates of reoperation and/or revision procedures at index level(s)
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Farhan Karim

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
DePuy Synthes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Farhan Karim, DO, Hartford Hospital; Hartford Healthcare Bone & Joint Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2021

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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