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

Primary Purpose

Cervical Radiculopathy, Cervical Myelopathy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Titan nanoLOCK interbody cage
ACDF interbody cage
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring spine, cervical, discectomy, bony fusion, dysphagia, radiographic fusion, radiographic adjacent segment disease

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Intervention Group

    Control Group

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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).
    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).
    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).
    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).
    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).
    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.
    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.
    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.
    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.
    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
    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

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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)
    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).
    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).
    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).
    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).
    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).

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    October 2, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Medtronic
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05762055
    Brief Title
    Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
    Official Title
    Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    May 2024 (Anticipated)
    Study Completion Date
    May 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    Medtronic

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy, Cervical Myelopathy
    Keywords
    spine, cervical, discectomy, bony fusion, dysphagia, radiographic fusion, radiographic adjacent segment disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention Group
    Arm Type
    Experimental
    Arm Description
    Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.
    Intervention Type
    Device
    Intervention Name(s)
    Titan nanoLOCK interbody cage
    Other Intervention Name(s)
    Titan nanoLOCK®
    Intervention Description
    Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
    Intervention Type
    Device
    Intervention Name(s)
    ACDF interbody cage
    Intervention Description
    Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology
    Primary Outcome Measure Information:
    Title
    Number of patient reported dysphagia events measured by Eat-10 assessment tool
    Description
    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.
    Time Frame
    Postoperative at Day 1
    Title
    Number of patient reported dysphagia events measured by Eat-10 assessment tool
    Description
    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.
    Time Frame
    2 weeks following surgery
    Title
    Number of patient reported dysphagia events measured by Eat-10 assessment tool
    Description
    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.
    Time Frame
    3 months following surgery
    Title
    Number of patient reported dysphagia events measured by Eat-10 assessment tool
    Description
    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.
    Time Frame
    6 months following surgery
    Title
    Number of patient reported dysphagia events measured by Eat-10 assessment tool
    Description
    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.
    Time Frame
    12 months following surgery
    Title
    Dysphagia as measured by SWAL-QOL assessment tool
    Description
    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).
    Time Frame
    Postoperative at day 1
    Title
    Dysphagia as measured by SWAL-QOL assessment tool
    Description
    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).
    Time Frame
    2 weeks following surgery
    Title
    Dysphagia as measured by SWAL-QOL assessment tool
    Description
    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).
    Time Frame
    3 months following surgery
    Title
    Dysphagia as measured by SWAL-QOL assessment tool
    Description
    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).
    Time Frame
    6 months following surgery
    Title
    Dysphagia as measured by SWAL-QOL assessment tool
    Description
    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).
    Time Frame
    12 months following surgery
    Title
    Degree of radiographic fusion
    Description
    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.
    Time Frame
    6 weeks following surgery
    Title
    Degree of radiographic fusion
    Description
    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.
    Time Frame
    3 months following surgery
    Title
    Degree of radiographic fusion
    Description
    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.
    Time Frame
    6 months following surgery
    Title
    Degree of radiographic fusion
    Description
    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.
    Time Frame
    12 months following surgery
    Title
    Incidence of radiographic adjacent segment disease
    Description
    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
    Time Frame
    6 months following surgery
    Title
    Incidence of radiographic adjacent segment disease
    Description
    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
    Time Frame
    12 months following surgery
    Secondary Outcome Measure Information:
    Title
    Percentage of participants experiencing neck pain
    Description
    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.
    Time Frame
    Baseline (Pre-op)
    Title
    Percentage of participants experiencing neck pain
    Description
    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.
    Time Frame
    6 weeks following surgery
    Title
    Percentage of participants experiencing neck pain
    Description
    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.
    Time Frame
    3 months following surgery
    Title
    Percentage of participants experiencing neck pain
    Description
    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.
    Time Frame
    6 months following surgery
    Title
    Percentage of participants experiencing neck pain
    Description
    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.
    Time Frame
    12 months following surgery
    Title
    Percentage of participants showing functional improvement
    Description
    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.
    Time Frame
    Baseline (Pre-op)
    Title
    Percentage of participants showing functional improvement
    Description
    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.
    Time Frame
    6 weeks following surgery
    Title
    Percentage of participants showing functional improvement
    Description
    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.
    Time Frame
    3 months following surgery
    Title
    Percentage of participants showing functional improvement
    Description
    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.
    Time Frame
    6 months following surgery
    Title
    Percentage of participants showing functional improvement
    Description
    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.
    Time Frame
    12 months following surgery
    Title
    Number of participants who experienced overall complications
    Description
    Overall complication rate is measured by number of participants who experienced overall complications (including instrumentation fracture, cage subsidence, revision surgery, and wound breakdown/infection)
    Time Frame
    3 years following surgery
    Title
    Percentage of participants reporting functional outcomes as measured by PROMIS-29
    Description
    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).
    Time Frame
    Baseline (Pre-op)
    Title
    Percentage of participants reporting functional outcomes as measured by PROMIS-29
    Description
    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).
    Time Frame
    6 weeks following surgery
    Title
    Percentage of participants reporting functional outcomes as measured by PROMIS-29
    Description
    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).
    Time Frame
    3 months following surgery
    Title
    Percentage of participants reporting functional outcomes as measured by PROMIS-29
    Description
    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).
    Time Frame
    6 months following surgery
    Title
    Percentage of participants reporting functional outcomes as measured by PROMIS-29
    Description
    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).
    Time Frame
    12 months following surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kristen Hall
    Phone
    214/645-0630
    Email
    Kristen.Hall@UTSouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Salah Aoun, MD
    Organizational Affiliation
    UT Southwestern Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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