Actively Recruiting
Comparison of Unconstrained and Semi-Constrained 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
21 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating two FDA-approved artificial disc implants used in cervical disc arthroplasty to treat cervical spondylotic myelopathy and/or radiculopathy caused by disc herniation or degenerative disc disease. The study compares the Biomet Zimmer Mobi-C, which has an unconstrained three-piece design, and the Nuvasive Simplify, which features a semi-constrained three-piece design with two endplates and a mobile core. This comparison aims to assess differences in patient outcomes and help inform personalized treatment decisions. Participants will be randomly assigned to receive either the Nuvasive Simplify or the Biomet Zimmer Mobi-C implant during cervical arthroplasty surgery. Both implants are inserted to replace a damaged disc in a single cervical spine level between C3 and C7. The study includes one baseline assessment before surgery and follow-up visits at three months, six months, and one year after the procedure, following standard care protocols. During the study, participants will undergo several evaluations including neck disability questionnaires, neurological exams such as gait and foraminal compression tests, and various radiographic assessments to measure disc height, angle, range of motion, translational motion, device subsidence, and intervertebral angles. The primary outcome is cervical range of motion measured at multiple time points. The total participation duration is approximately one and a half years, allowing for comprehensive monitoring of outcomes and safety.
CONDITIONS
Brief 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
- Has cervical spondylotic myelopathy and/or radiculopathy caused by disc herniation or degenerative disc disease at a single level between C3 and C7
- Is unresponsive to at least six weeks of non-surgical conservative care
- Intends to undergo cervical arthroplasty for their condition
- Has signed an informed consent form
You will not qualify if you...
- Has had prior cervical spine surgery
- Has more than two diseased levels requiring surgery
- Has a known allergy to metal alloy or polyethylene
- Is morbidly obese
- Has an active local or systemic infection
- Has conditions that impair ability to provide informed consent, comply with follow-up, or complete self-assessments (e.g., psychiatric disorders, substance abuse)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo cervical arthroplasty where an artificial disc implant is inserted to replace a damaged cervical disc.
1 surgery visit (in-person)
Duration - 12 months
Participants attend follow-up visits that include assessments of neck disability, quality of life, pain, neurological function, radiographic outcomes, and neck range of motion after the surgery.
3 visits (at 3 months, 6 months, and 1 year post-operation, in-person)
Trial Site Locations
Total: 1 location
1
UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
D
Daniel C Lu, MD, PhD
S
Sandra Holley, PhD
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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