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Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Recruitingn/aAges 18 Years - 60 YearsAllUniversity of California, Los Angeles
NCT05701059 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Cervical arthroplasty
  • Semi-Constrained Nuvasive Simplify
  • Unconstrained Biomet Zimmer Mobi-C
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Where

1 site
UCLA
Los Angeles, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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