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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology
University of Texas Southwestern Medical Center
Dallas, Texas, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 12 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Pre-op)
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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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months following surgery