NCT05762055

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

Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cervical Radiculopathy
• Cervical Myelopathy

Interventions

Type	Name	Description
DEVICE	Titan nanoLOCK interbody cage	Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
DEVICE	ACDF interbody cage	Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology

Timeline

• Start date: 2024-02-05
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2023-03-09
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study