RecruitingNCT05701059

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Comparison of Unconstrained and Semi-constrained Artificial Disc Implants Used in Cervical Disc Arthroplasty


Sponsor

University of California, Los Angeles

Enrollment

20 participants

Start Date

May 1, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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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Interventions

PROCEDURECervical arthroplasty

A joint replacement procedure administered by inserting an artificial disc between the vertebrae to replace a natural spinal disc after it has been removed.

DEVICESemi-Constrained Nuvasive Simplify

This weight-bearing implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile zirconia toughened alumina (ZTA) ceramic core will be administered by cervical arthroplasty into the specified single-level cervical region.

DEVICEUnconstrained Biomet Zimmer Mobi-C

This unconstrained, three-piece implant will be administered by cervical arthroplasty into the specified single-level cervical region.


Locations(1)

UCLA

Los Angeles, California, United States

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NCT05701059


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