ACTIVE_NOT_RECRUITING

Lumbar Fusion With Porous Versus Non-Porous Cages

Conditions

Spinal Fusion Lumbar Fusion Arthrodesis Spondylolisthesis Pseudarthrosis Spinal Cage PEEK Titanium Fusion Transforaminal Interbody Posterolateral CONDUIT PROTI 360 TLIF

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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

The objective of this single site, randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo lumbar interbody fusion procedures (TLIF), supplemented with pedicle screw instrumentation, using one of the following interventions: 1. Porous titanium cages 2. Non-porous titanium-coated poly-ether-ether-ketone (PEEK) cages.

Official Title

Lumbar Fusion With Porous Titanium Versus Non-Porous Titanium-Coated PEEK Interbody Cages - A Randomized Controlled Trial

Quick Facts

Study Start:2022-11-01

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05583864

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:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system. 2. They are over the age of 18 years old. 3. They have been unresponsive to conservative care for a minimum of 6 months. 4. They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.	1. They have had previous lumbar arthrodesis surgery. 2. They require additional bone grafting materials other than local autograft bone. 3. There is inadequate tissue coverage over the operative site. 4. There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis. 5. Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.). 6. Subject has an active local or systemic infection. 7. Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted). 8. Subject is morbidly obese, defined as a body mass index (BMI) greater than 40. 9. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 10. Subject is currently involved in another investigational drug or device study that could confound study data. 11. There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. 12. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care. 13. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams. 14. Subject is a prisoner.

Inclusion Criteria

Exclusion Criteria

1. They are scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the DePuy Synthes CONDUIT™ porous titanium cage or the DePuy Synthes PROTI 360º™ non-porous titanium-coated PEEK cage in conjunction with local autograft bone, and supplementation with a pedicle screw system.
2. They are over the age of 18 years old.
3. They have been unresponsive to conservative care for a minimum of 6 months.
4. They are in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent.

1. They have had previous lumbar arthrodesis surgery.
2. They require additional bone grafting materials other than local autograft bone.
3. There is inadequate tissue coverage over the operative site.
4. There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
5. Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
6. Subject has an active local or systemic infection.
7. Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
8. Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
9. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
10. Subject is currently involved in another investigational drug or device study that could confound study data.
11. There is a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up.
12. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. This restriction is due to the inherent risk radiography presents to an embryo or fetus and is considered standard of care.
13. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. Participation may effect the assessments made by case workers and legal teams.
14. Subject is a prisoner.

Contacts and Locations

Principal Investigator

Francis Farhadi, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Kentucky

Craig van Horne, MD, PhD

STUDY_DIRECTOR

University of Kentucky

Study Locations (Sites)

University of Kentucky

Lexington, Kentucky, 40536

United States

Collaborators and Investigators

Sponsor: University of Kentucky

Francis Farhadi, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Kentucky
Craig van Horne, MD, PhD, STUDY_DIRECTOR, University of Kentucky

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 Date2022-11-01

Study Completion Date2026-05

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Spinal Cage
PEEK
Pseudarthrosis
Spondylolisthesis
Titanium
Fusion
Transforaminal
Interbody
Posterolateral
CONDUIT
PROTI 360
TLIF

Additional Relevant MeSH Terms

Spinal Fusion
Lumbar Fusion
Arthrodesis
Spondylolisthesis
Pseudarthrosis