← Back to Search

Interbody Cage

Intervention Group for Cervical Radiculopathy

N/A
Waitlist Available
Led By Salah Aoun, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with no prior history of cervical spine surgery
Subjects undergoing ACDF surgery for degenerative pathology (one, two or three levels)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years following surgery
Awards & highlights

Study Summary

This trial aims to compare the outcomes of two different types of interbody cages used during a surgical procedure called ACDF. One group of patients will receive a cage with a specific technology called nanoLOCK os

Who is the study for?
This trial is for adults 18+ who need ACDF surgery due to degenerative issues in one, two, or three levels of their cervical spine and haven't had previous neck surgeries. Participants must also have complete data that can be used for the study.Check my eligibility
What is being tested?
The study compares two types of interbody cages used in ACDF surgery: Titan nanoLOCK cage with osseointegrative technology versus a standard cage without this technology. It's randomized with no blinding, involving 200 patients split into two groups.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include pain at the graft site, nerve damage, problems swallowing or speaking, infection risk at the surgical site and general anesthesia complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have never had surgery on my neck.
Select...
I am having neck surgery for degeneration affecting up to three spinal levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years following surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years following surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Degree of radiographic fusion
Dysphagia as measured by SWAL-QOL assessment tool
Incidence of radiographic adjacent segment disease
+1 more
Secondary outcome measures
Number of participants who experienced overall complications
Percentage of participants experiencing neck pain
Percentage of participants reporting functional outcomes as measured by PROMIS-29
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment1 Intervention
Medtronic Titan Endoskeleton TCS zero-profile, stand-alone interbody cages with nanoLOCK osseointegrative technology will be implanted for participants in this group
Group II: Control GroupExperimental Treatment1 Intervention
Participants in this arm will receive an alternative interbody cage system that does not employ nanoLOCK ossteointegrative technology.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,048 Previous Clinical Trials
1,053,575 Total Patients Enrolled
MedtronicIndustry Sponsor
606 Previous Clinical Trials
828,465 Total Patients Enrolled
Salah Aoun, MDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
485 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment for this medical study currently accepting new participants?

"Indeed, according to the information available on clinicaltrials.gov, this trial is actively seeking eligible candidates. The trial was initially posted on February 1st, 2024 and recently edited on January 18th, 2024. The study aims to recruit a total of 200 participants from a single designated location."

Answered by AI

Is the clinical trial open to individuals below the age of 85?

"In order to participate in this clinical trial, individuals must be at least 18 years old and there is no upper age limit, allowing enrollment for patients up to the age of 99."

Answered by AI

What are the main goals being pursued in this medical study?

"The primary focus of this trial is to evaluate the level of radiographic fusion within a 12-month period following surgery. Secondary outcomes include assessing the percentage of participants experiencing neck pain using the VAS-neck questionnaire, measuring functional improvement using the Neck Disability Index (NDI) questionnaire, and determining the number of participants who encountered overall complications such as instrumentation fracture, cage subsidence, revision surgery, and wound breakdown/infection."

Answered by AI

What is the total number of individuals participating in this research trial?

"Indeed, the information available on clinicaltrials.gov confirms that this particular clinical trial is actively searching for suitable candidates. The study was initially posted on February 1st, 2024 and most recently updated on January 18th, 2024. It aims to enroll a total of 200 participants from one designated location."

Answered by AI

Would it be possible for me to participate in this medical study?

"- Participants should possess complete and usable data for analysis."

Answered by AI

Who else is applying?

What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology
Salah Aoun 2024. "Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05762055.
All > Cervical Spondylotic Myelopathy
~133 spots leftby May 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top