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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

No Placebo-Only Group

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.

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I am having neck surgery for degeneration affecting up to three spinal levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years following surgery

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 2Eligibility criteria met