Trial Summary
What is the purpose of this trial?Study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. Eligible patients undergoing ACDF (see inclusion criteria listed below) will be randomized to an Intervention or Control Group, which will differ according to the interbody cage used during the procedure. In the Intervention Group (100 patients), Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted at each treated level. In the Control Group (100 patients), patients will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. Interbody cages used in the Control Group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. There will be no blinding to the type of implant used. Standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). Clinical and radiographic outcomes in the Intervention and Control Groups will be directly compared.
Eligibility Criteria
This trial is for adults 18+ who need ACDF surgery due to degenerative issues in one, two, or three levels of their cervical spine and haven't had previous neck surgeries. Participants must also have complete data that can be used for the study.Inclusion Criteria
I am 18 years old or older.
I have never had surgery on my neck.
I am having neck surgery for degeneration affecting up to three spinal levels.
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Participant Groups
The study compares two types of interbody cages used in ACDF surgery: Titan nanoLOCK cage with osseointegrative technology versus a standard cage without this technology. It's randomized with no blinding, involving 200 patients split into two groups.
2Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group
Group II: Control GroupExperimental Treatment1 Intervention
Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Texas Southwestern Medical CenterDallas, TX
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Who Is Running the Clinical Trial?
University of Texas Southwestern Medical CenterLead Sponsor
MedtronicIndustry Sponsor