Cervical RadiculopathyNCT05762055
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
A study testing Titan nanoLOCK interbody cage and ACDF interbody cage in people with Cervical Radiculopathy and Cervical Myelopathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cervical Radiculopathy, Cervical Myelopathy
- What is being tested?
- Titan nanoLOCK interbody cage and ACDF interbody cage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
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 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.
Read the 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.
- Conditions
- Cervical Radiculopathy, Cervical Myelopathy
- Being tested
- Titan nanoLOCK interbody cage, ACDF interbody cage
- Keywords
- spine, cervical, discectomy, bony fusion, dysphagia, radiographic fusion, radiographic adjacent segment disease
- Medical subject headings
- Radiculopathy, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titan nanoLOCK interbody cageDevice
Also called Titan nanoLOCK®
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology
ACDF interbody cageDevice
Anterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: ACDF interbody cage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 12 months following surgery
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start5 Feb 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical RadiculopathyStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Salah Aoun, University of Texas Southwestern Medical Center
- Investigators
- Salah Aoun, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762055
- Sponsor's protocol ID
- STU-2022-1092
- Status last verified
- May 2026
- First submitted
- 27 Feb 2023
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Analysis Evaluating Radiographic and Clinical Outcomes of Stand-Alone Anterior Cervical Discectomy and Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
- ClinicalTrials.gov ID
- NCT05762055
- Acronym / sponsor ID
- STU-2022-1092
- Conditions
- Cervical Radiculopathy, Cervical Myelopathy
- Keywords
- spine, cervical, discectomy, bony fusion, dysphagia, radiographic fusion, radiographic adjacent segment disease
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Titan nanoLOCK interbody cageMedtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group |
| Control Group | Experimental | Device: ACDF interbody cageParticipants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Titan nanoLOCK interbody cageAlso: Titan nanoLOCK®Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology | Device | Intervention Group |
| ACDF interbody cageAnterior cervical discectomy and fusion (ACDF) is an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology | Device | Control Group |
Primary outcome
Number of patient reported dysphagia events measured by Eat-10 assessment tool
Time frame: Postoperative 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 tool
Time frame: 2 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 tool
Time frame: 3 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 tool
Time frame: 6 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 tool
Time frame: 12 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 tool
Time frame: Postoperative 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 tool
Time frame: 2 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 tool
Time frame: 3 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 tool
Time frame: 6 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 tool
Time frame: 12 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 fusion
Time frame: 6 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 fusion
Time frame: 3 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 fusion
Time frame: 6 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 fusion
Time frame: 12 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 disease
Time frame: 6 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 disease
Time frame: 12 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
16 secondary outcomes
Percentage of participants experiencing neck pain
Time frame: Baseline (Pre-op)
Percentage of participants experiencing neck pain
Time frame: 6 weeks following surgery
Percentage of participants experiencing neck pain
Time frame: 3 months following surgery
Percentage of participants experiencing neck pain
Time frame: 6 months following surgery
Percentage of participants experiencing neck pain
Time frame: 12 months following surgery
Percentage of participants showing functional improvement
Time frame: Baseline (Pre-op)
Percentage of participants showing functional improvement
Time frame: 6 weeks following surgery
Percentage of participants showing functional improvement
Time frame: 3 months following surgery
Percentage of participants showing functional improvement
Time frame: 6 months following surgery
Percentage of participants showing functional improvement
Time frame: 12 months following surgery
Number of participants who experienced overall complications
Time frame: 3 years following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29
Time frame: Baseline (Pre-op)
Percentage of participants reporting functional outcomes as measured by PROMIS-29
Time frame: 6 weeks following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29
Time frame: 3 months following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29
Time frame: 6 months following surgery
Percentage of participants reporting functional outcomes as measured by PROMIS-29
Time frame: 12 months following surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Not yet recruiting
Endoscopic Posterior Cervical Foraminotomy Versus Anterior Cervical Discectomy and Fusion for Cervical Radiculopathy
Cervical Disc Herniation, Cervical Foraminal Stenosis
RecruitingObservational study
Cervical Spinal Cord Signal Abnormalities in Patients With Cervical Radicular Pain
Cervical Radiculopathy, Cervical Myelomalacia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Salah Aoun, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Titan nanoLOCK interbody cage and ACDF interbody cage in people with Cervical Radiculopathy and Cervical Myelopathy, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient reported dysphagia events measured by Eat-10 assessment tool (time frame: Postoperative at Day 1). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.