Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Recruiting now

Conditions studied: Cervical Spondylosis With Myelopathy, Cervical Radiculopathy, Cervical Disc Herniation, Degenerative Disc Disease

In brief

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.

Key facts

Study ID

NCT05701059

Run by

University of California, Los Angeles

People needed

20

Starts

2023-05-01

Expected to finish

2026-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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.)

Where it is running

• UCLA — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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