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NCT05762055

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

Enrolling by Invitation
NAAges 18–99InterventionalTreatment
University of Texas Southwestern Medical Center
~200 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Titan nanoLOCK interbody cageACDF interbody cage

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patient reported dysphagia events measured by Eat-10 assessment tool
Measured over Postoperative at Day 1
+15 more outcomes measured

Conditions

Cervical Radiculopathy
Cervical Myelopathy

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Salah Aoun, MD · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of patient reported dysphagia events measured by Eat-10 assessment toolPostoperative at Day 1

    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.

  • Number of patient reported dysphagia events measured by Eat-10 assessment tool2 weeks following surgery

    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.

  • Number of patient reported dysphagia events measured by Eat-10 assessment tool3 months following surgery

    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.

  • Number of patient reported dysphagia events measured by Eat-10 assessment tool6 months following surgery

    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.

  • Number of patient reported dysphagia events measured by Eat-10 assessment tool12 months following surgery

    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.

  • Dysphagia as measured by SWAL-QOL assessment toolPostoperative at day 1

    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).

  • Dysphagia as measured by SWAL-QOL assessment tool2 weeks following surgery

    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).

  • Dysphagia as measured by SWAL-QOL assessment tool3 months following surgery

    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).

  • Dysphagia as measured by SWAL-QOL assessment tool6 months following surgery

    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).

  • Dysphagia as measured by SWAL-QOL assessment tool12 months following surgery

    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).

  • Degree of radiographic fusion6 weeks following surgery

    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.

  • Degree of radiographic fusion3 months following surgery

    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.

  • Degree of radiographic fusion6 months following surgery

    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.

  • Degree of radiographic fusion12 months following surgery

    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.

  • Incidence of radiographic adjacent segment disease6 months following surgery

    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

  • Incidence of radiographic adjacent segment disease12 months following surgery

    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