Actively Recruiting

Age: 18Years - 60Years
All Genders
NCT05701059

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Led by University of California, Los Angeles · Updated on 2026-02-13

20

Participants Needed

1

Research Sites

187 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.

CONDITIONS

Official Title

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is skeletally mature and between 18 to 60 years of age
  • Experiences cervical spondylotic myelopathy and/or radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7
  • Is unresponsive to at least six weeks of non-surgical conservative care
  • Has the intention of undergoing cervical arthroplasty for their chief complaint
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Patient has had prior cervical spine surgery
  • Has more than two diseased levels requiring surgery
  • Has a known allergy to a metal alloy or polyethylene
  • Is morbidly obese
  • Has active local or system infection
  • Has any circumstances or conditions such that their ability to provide informed consent comply with follow-up requirements, or provide self-assessments is compromised (eg: psychiatric disorders, chronic alcohol or substance abuse, etc.)

AI-Screening

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Trial Site Locations

Total: 1 location

1

UCLA

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

D

Daniel C Lu, MD, PhD

CONTACT

S

Sandra Holley, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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