Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
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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