Lumbar Fusion With Porous Versus Non-Porous Cages
Running, not enrolling · Not applicable
Conditions studied: Spinal Fusion, Lumbar Fusion, Arthrodesis, Spondylolisthesis, Pseudarthrosis
In brief
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.
Key facts
- Study ID
- NCT05583864
- Run by
- Francis Farhadi
- People needed
- 108
- Starts
- 2022-11-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients will be considered for inclusion if:
- 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.
- They are over the age of 18 years old.
- They have been unresponsive to conservative care for a minimum of 6 months.
- 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.
You may not qualify if…
- Certain comorbidities and medical statuses may render patients ineligible for surgery, or put them at an increased risk for complications or injury by participating in the study. Therefore, patients will be excluded from enrollment if:
- They have had previous lumbar arthrodesis surgery.
- They require additional bone grafting materials other than local autograft bone.
- There is inadequate tissue coverage over the operative site.
- There is an open wound local to the operative area, or rapid joint disease, bone absorption, or osteoporosis.
- Subject has a condition requiring medications that may interfere with bone or soft tissue healing(i.e., oral or parenteral glucocorticoids, immunosuppressives, methotrexate, etc.).
- Subject has an active local or systemic infection.
- Subject has a metal sensitivity/foreign body sensitivity (cages will be implanted).
- Subject is morbidly obese, defined as a body mass index (BMI) greater than 40.
- Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study.
- Subject is currently involved in another investigational drug or device study that could confound study data.
- 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.
- 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.
- 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.
- Subject is a prisoner.
Where it is running
- University of Kentucky — Lexington, Kentucky, United States
Full record on ClinicalTrials.gov
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