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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cervical Radiculopathy; Cervical Myelopathy
• Intervention / Treatment: Device: Titan nanoLOCK interbody cage; Device: ACDF interbody cage

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristen Hall; Phone Number: 214/645-0630; Email: Kristen.Hall@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; 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; Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology; Other Names: Titan nanoLOCK®
Experimental: Control Group; Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.	Device: ACDF interbody cage; Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of participants experiencing neck pain	Percentage of participants experiencing neck pain is assessed using VAS-neck questionnaire. Possible scores range from 0-10, where 0=no pain and 10= worst pain imaginable.	Baseline (Pre-op)
Percentage of participants experiencing neck pain	Percentage of participants experiencing neck pain is assessed using Vissual Analogue Scale (VAS)-neck questionnaire. Possible scores range from 0-10, where 0=no pain and 10= worst pain imaginable.	6 weeks following surgery
Percentage of participants experiencing neck pain	Percentage of participants experiencing neck pain is assessed using VAS-neck questionnaire. Possible scores range from 0-10, where 0=no pain and 10= worst pain imaginable.	3 months following surgery
Percentage of participants experiencing neck pain	Percentage of participants experiencing neck pain is assessed using VAS-neck questionnaire. Possible scores range from 0-10, where 0=no pain and 10= worst pain imaginable.	6 months following surgery
Percentage of participants experiencing neck pain	Percentage of participants experiencing neck pain is assessed using VAS-neck questionnaire. Possible scores range from 0-10, where 0=no pain and 10= worst pain imaginable.	12 months following surgery
Percentage of participants showing functional improvement	Percentage of participants showing functional improvement is assessed using Neck Disability Index (NDI) questionnaire. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.	Baseline (Pre-op)
Percentage of participants showing functional improvement	Percentage of participants showing functional improvement is assessed using Neck Disability Index (NDI) questionnaire. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.	6 weeks following surgery
Percentage of participants showing functional improvement	Percentage of participants showing functional improvement is assessed using Neck Disability Index (NDI) questionnaire. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.	3 months following surgery
Percentage of participants showing functional improvement	Percentage of participants showing functional improvement is assessed using Neck Disability Index (NDI) questionnaire. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.	6 months following surgery
Percentage of participants showing functional improvement	Percentage of participants showing functional improvement is assessed using Neck Disability Index (NDI) questionnaire. Each question contains six answer choices, scored from 0 (no disability) to 5 (complete disability). All section scores are then totaled. Scoring is reported on a 0-50 scale, 0 being the best possible score and 50 being the worst.	12 months following surgery
Number of participants who experienced overall complications	Overall complication rate is measured by number of participants who experienced overall complications (including instrumentation fracture, cage subsidence, revision surgery, and wound breakdown/infection)	3 years following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29	Percentage of participants reporting functional outcomes is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire which contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).	Baseline (Pre-op)
Percentage of participants reporting functional outcomes as measured by PROMIS-29	Percentage of participants reporting functional outcomes is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire which contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).	6 weeks following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29	Percentage of participants reporting functional outcomes is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire which contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).	3 months following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29	Percentage of participants reporting functional outcomes is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire which contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).	6 months following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29	Percentage of participants reporting functional outcomes is measured by Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire which contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).	12 months following surgery

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: Salah Aoun, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: spine; dysphagia; discectomy; cervical; bony fusion; radiographic fusion; radiographic adjacent segment disease
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy; Spinal Cord Diseases
• Other Study ID Numbers: STU-2022-1092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No