Clinical Trial Finder

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 35 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05023733
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Farhan Karim
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Farhan Karim, DO
Principal Investigator Affiliation Hartford Hospital; Hartford Healthcare Bone & Joint Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Foraminal Stenosis, Degenerative Disc Disease, Lumbar Spondylolisthesis, Lumbar Spinal Stenosis
Additional Details

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.

Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Hartford, Connecticut

Status

Recruiting

Address

Hartford Healthcare Bone and Joint Institute

Hartford, Connecticut, 06106

Site Contact

Bethany Samperi

[email protected]

860-972-5978

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