Spine surgery showdown: new titanium cage may fuse bones faster
NCT ID NCT05182489
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two types of spinal fusion cages used in back surgery: a new titanium cage with a special rough surface and a standard plastic cage. About 100 adults with spine problems like narrowing of the spinal canal or slipped vertebrae will be randomly assigned to receive one of the cages. The main goal is to see which cage leads to better bone fusion at 6 months after surgery.
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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 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Apr 2026
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 years and older
- 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subject is scheduled to undergo combined interbody and posterolateral spinal fusion surgery using either the Medtronic Adaptix™ titanium cage or Medtronic CAPSTONE® PEEK cage in conjunction with a 50:50 mixture of local autograft and GRAFTON™ DBM DBF, and supplementation with a pedicle screw system. 2. Subject must be over the age of 18 years old. 3. Subject has been unresponsive to conservative care for a minimum of 6 months. 4. The subject must 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: 1. Subjects with previous lumbar arthrodesis surgery. 2. Subjects requiring additional bone grafting materials other than local autograft bone or GRAFTON™ DBM DBF. 3. Subject has inadequate tissue coverage over the operative site. 4. Subject has 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. 8. Subject is allergic to antibiotics (gentamicin) or processing solutions found in GRAFTON™. 9. Subject is morbidly obese, defined as a body mass index (BMI) greater than 45. 10. Subject has any medical condition or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the study. 11. Subject is currently involved in another investigational drug or device study that could confound study data. 12. Subject has 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. 13. Subjects who are pregnant or plan to become pregnant in the next 12 months or who are lactating. 14. Subject is involved in or planning to engage in litigation or receiving Worker's Compensation related to neck or back pain. 15. 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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The Ohio State University Wexner Medical Center Neurological Surgery
Columbus, Ohio, 43219, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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