Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

Enrolling by invitation · Not applicable

Conditions studied: Cervical Radiculopathy, Cervical Myelopathy

In brief

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.

Key facts

Study ID

NCT05762055

Run by

University of Texas Southwestern Medical Center

People needed

200

Starts

2024-02-05

Expected to finish

2026-05-01

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.