Comparing porous and non-porous cages for lumbar fusion surgery

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

This study is testing whether using porous titanium cages instead of non-porous cages during back surgery can help patients heal better and have fewer problems afterward.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 108 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Lexington, Kentucky)
• Trial ID: NCT05583864 on ClinicalTrials.gov

What this trial studies

This randomized controlled trial aims to evaluate the safety and efficacy of porous titanium cages versus non-porous titanium-coated PEEK cages in patients undergoing lumbar interbody fusion procedures. The study will follow participants for up to 2 years post-surgery, assessing both clinical and radiographic outcomes. A total of 108 subjects will be enrolled, with the expectation that the porous titanium cages will achieve better fusion rates compared to the PEEK cages. The trial is designed to provide insights into which type of cage may lead to improved surgical outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who have not responded to conservative care for at least 6 months and are scheduled for lumbar fusion surgery.

Not a fit: Patients with certain comorbidities or those who are not suitable for surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved fusion rates and better clinical outcomes for patients undergoing lumbar fusion surgery.

How similar studies have performed: Previous studies have shown varying success with different types of spinal cages, but this specific comparison of porous versus non-porous cages is relatively novel.

Eligibility criteria

Inclusion Criteria:

Patients will be considered for inclusion if:

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.

Exclusion Criteria:

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:

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.

Where this trial is running

Lexington, Kentucky

• University of Kentucky — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Francis Farhadi, MD, PhD — University of Kentucky
• Study coordinator: Francis Farhadi, MD, PhD

Conditions Spinal Fusion; Lumbar Fusion; Arthrodesis; Spondylolisthesis; Pseudarthrosis; Spinal Cage; PEEK; Titanium