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Interbody Cage

Interbody Cages for Cervical Myelopathy

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

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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Degree of radiographic fusion
Dysphagia as measured by SWAL-QOL assessment tool
Incidence of radiographic adjacent segment disease
+1 more
Secondary study objectives
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
1,072 Previous Clinical Trials
1,056,062 Total Patients Enrolled
MedtronicIndustry Sponsor
613 Previous Clinical Trials
759,533 Total Patients Enrolled
Salah Aoun, MDPrincipal InvestigatorUT Southwestern Medical Center
1 Previous Clinical Trials
485 Total Patients Enrolled
~100 spots leftby May 2025
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