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

NCT05762055 | Enrolling By Invitation FDA Device

• 1 other identifier: STU-2022-1092
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Radiculopathy; Cervical Myelopathy

Keywords

spine; cervical; discectomy; bony fusion; dysphagia; radiographic fusion; radiographic adjacent segment disease

Outcome Measures

Primary Outcomes (16)

• Number of patient reported dysphagia events measured by Eat-10 assessment tool

  Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.

  Postoperative at Day 1

• Number of patient reported dysphagia events measured by Eat-10 assessment tool

  Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.

  2 weeks following surgery

• Number of patient reported dysphagia events measured by Eat-10 assessment tool

  Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.

  3 months following surgery

• Number of patient reported dysphagia events measured by Eat-10 assessment tool

  Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.

  6 months following surgery

• Number of patient reported dysphagia events measured by Eat-10 assessment tool

  Number of patient reported dysphagia events (incidence \& severity ) is measured by Eating Assessment Tool (EAT-10) post surgery at day1 which is self-administered, symptom-specific outcome instrument for dysphagia. It consists of ten statements that a patient rates on a scale of 0-4, with 0=no problem to 4=severe problem.

  12 months following surgery

• Dysphagia as measured by SWAL-QOL assessment tool

  Dysphagia is measured by SWAL-QOL assessment tool which is designed to find out how one's swallowing problem has been affecting their day-to-day quality of life. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).

  Postoperative at day 1

• Dysphagia as measured by SWAL-QOL assessment tool

  Dysphagia is measured by SWAL-QOL assessment tool which is designed to find out how one's swallowing problem has been affecting their day-to-day quality of life. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).

  2 weeks following surgery

• Dysphagia as measured by SWAL-QOL assessment tool

  Dysphagia is measured by SWAL-QOL assessment tool which is used in understanding quality of life in swallowing disorders. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).

  3 months following surgery

• Dysphagia as measured by SWAL-QOL assessment tool

  Dysphagia is measured by SWAL-QOL assessment tool which is designed to find out how one's swallowing problem has been affecting their day-to-day quality of life. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).

  6 months following surgery

• Dysphagia as measured by SWAL-QOL assessment tool

  Dysphagia is measured by SWAL-QOL assessment tool which is designed to find out how one's swallowing problem has been affecting their day-to-day quality of life. Scoring in each domain is calculated by the sums of scores for each item expressed as a percentage of the maximum possible domain score. A total SWAL-QOL score is derived by summing each domain score and dividing by 10 giving a total SWAL-QOL score that ranges between 0 and 100 (worst-best).

  12 months following surgery

• Degree of radiographic fusion

  Degree of radiographic fusion is measured by quantifying (count of) the presence of bony trabeculae crossing the interface between the implant and adjacent levels as obtained via CT of the cervical spine.

  6 weeks following surgery

• Degree of radiographic fusion

  Degree of radiographic fusion is measured by quantifying (count of) the presence of bony trabeculae crossing the interface between the implant and adjacent levels as obtained via CT of the cervical spine.

  3 months following surgery

• Degree of radiographic fusion

  Degree of radiographic fusion is measured by quantifying (count of) the presence of bony trabeculae crossing the interface between the implant and adjacent levels as obtained via CT of the cervical spine.

  6 months following surgery

• Degree of radiographic fusion

  Degree of radiographic fusion is measured by quantifying (count of) the presence of bony trabeculae crossing the interface between the implant and adjacent levels as obtained via CT of the cervical spine.

  12 months following surgery

• Incidence of radiographic adjacent segment disease

  Incidence of radiographic adjacent segment disease is measured by quantifying (number of occurrence) the following parameters (i.e., Suprajacent and/or subjacent level kyphosis; Vacuum disc phenomenon at adjacent level discs; Adjacent level compression deformity) on postoperative imaging

  6 months following surgery

• Incidence of radiographic adjacent segment disease

  Incidence of radiographic adjacent segment disease is measured by quantifying (number of occurrence) the following parameters (i.e., Suprajacent and/or subjacent level kyphosis; Vacuum disc phenomenon at adjacent level discs; Adjacent level compression deformity) on postoperative imaging

  12 months following surgery

Secondary Outcomes (16)

• Percentage of participants experiencing neck pain

  Baseline (Pre-op)

• Percentage of participants experiencing neck pain

  6 weeks following surgery

• Percentage of participants experiencing neck pain

  3 months following surgery

• Percentage of participants experiencing neck pain

  6 months following surgery

• Percentage of participants experiencing neck pain

  12 months following surgery

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: Titan nanoLOCK interbody cage

Control Group

EXPERIMENTAL

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

Device: ACDF interbody cage

Interventions

Titan nanoLOCK interbody cage DEVICE

Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology

Also known as: Titan nanoLOCK®

Intervention Group

ACDF interbody cage DEVICE

Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology

Control Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Medtronic: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Radiculopathy; Deglutition Disorders

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Salah Aoun, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: February 5, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)