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

The University of Texas System (UT)

Status: Invitation-only

Conditions: Cervical Myelopathy; Cervical Radiculopathy

Treatments: Device: Titan nanoLOCK interbody cage; Device: ACDF interbody cage

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05762055

STU-2022-1092

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group

Treatment:

Device: Titan nanoLOCK interbody cage

Control Group

Experimental group

Description:

Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.

Treatment:

Device: ACDF interbody cage