University of Texas Southwestern Medical Center
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.
Aim 1: Examine the effect of nanoLOCK technology on rates of postoperative dysphagia after ACDF. Aim 2: Evaluate the effect of nanoLOCK technology on radiographic fusion. Aim 3: Evaluate how nanoLOCK technology influences the development of radiographic adjacent segment disease.
Inclusion Criteria: * Subjects 18 years of age or older * Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels) * Subjects with no prior history of cervical spine surgery * Subjects with complete/usable data Exclusion Criteria: * Subjects under the age of 18 * Subjects not undergoing ACDF surgery * Subjects with prior cervical spine surgery * Subjects with cervical neoplastic or infectious disease pathology * Subjects with cervical trauma pathology * ACDF performed at C2-3 * Subjects with incomplete/unusable data
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology