Spinal fusion cage showdown: which material wins?
NCT ID NCT05583864
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study compares two types of spinal fusion cages—porous titanium and titanium-coated PEEK—in 108 adults undergoing lower back surgery. The goal is to see which cage helps bones fuse better and improves pain and quality of life. Participants were randomly assigned to receive one of the two cages during their procedure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 108 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Kentucky
Lexington, Kentucky, 40536, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a new bone graft match the gold standard for spinal fusion?
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- Can a growth factor from donor bone improve spinal fusion?
- Can a One-Day mindset workshop stop chronic pain after back surgery?
- Can a brace and targeted exercises ease spondylolisthesis pain?