Artificial Disc Implants for Cervical Spine Conditions
Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
Recruiting
Observational Study
Cervical Spondylosis With MyelopathyCervical RadiculopathyCervical Disc HerniationDegenerative Disc Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Observational
Participants needed
20 (estimated)
Sponsor
University of California, Los Angeles · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 60 who have specific neck problems caused by disc issues and haven’t improved with non-surgical treatments. Participants will receive one of two types of artificial discs and will be monitored over one and a half years.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 60 years old.
I have cervical spondylotic myelopathy and/or radiculopathy.
I have not improved after at least six weeks of conservative care.
I plan to have cervical arthroplasty for my condition.
I have signed the informed consent form.
You may not be able to join if
I have had prior cervical spine surgery.
I have more than two diseased levels that need surgery.
I am allergic to metal or polyethylene.
I am morbidly obese.
I have an active local or systemic infection.
I have conditions that affect my ability to give consent or participate.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 co…
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.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* 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-…
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.)
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