RECRUITING

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

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Conditions

Foraminal StenosisDegenerative Disc DiseaseLumbar SpondylolisthesisLumbar Spinal Stenosistransforaminaldegenerative disc disease (DDD)Lumbar FusionInterbody Fusion

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical and Radiographic Outcomes of Transforaminal Lumbar Interbody Fusion (TLIF) With a Novel 3D Printed Cellular Titanium Implant

Quick Facts

Study Start:2021-10-01
Study Completion:2025-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023733

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.

Ages Eligible for Study:35 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Skeletally mature adults ages 35 - 80 years of age, inclusive
  2. * Diagnosis of lumbar degenerative disc disease with or without neurologic deficit and associated central and/or unilateral/bilateral foraminal stenosis
  3. * Subject undergoing one or two level transforaminal lumbar interbody fusion
  4. * Able to read and understand all documents used in this study , including the informed consent and patient-reported outcome questionnaires
  1. * Patients over 80 years of age
  2. * Patients under 35 years of age
  3. * Current smokers
  4. * BMI\>42
  5. * Subject has spondylolisthesis \> 2
  6. * Subjects with multilevel \>2 levels of symptomatic disease
  7. * Subjects with significant spinal deformity
  8. * Subject is pregnant, plans to become pregnant or is breast feeding

Contacts and Locations

Study Contact

Bethany Samperi
CONTACT
860-972-5978
bethany.samperi@hhchealth.org
Matthew Solomito, PhD
CONTACT
203-525-7659
matthew.solomito@hhchealth.org

Principal Investigator

Farhan Karim, DO
PRINCIPAL_INVESTIGATOR
Hartford Hospital; Hartford Healthcare Bone & Joint Institute

Study Locations (Sites)

Hartford Healthcare Bone and Joint Institute
Hartford, Connecticut, 06106
United States

Collaborators and Investigators

Sponsor: Farhan Karim

  • Farhan Karim, DO, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-10-01
Study Completion Date2025-10-01

Study Record Updates

Study Start Date2021-10-01
Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Foraminal Stenosis
  • Degenerative Disc Disease
  • Lumbar Spondylolisthesis
  • Lumbar Spinal Stenosis