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

Plain Language Summary

Simplified for easier understanding

This study compares two different artificial disc implants used in cervical disc arthroplasty — a surgery that replaces a damaged disc in the neck with an artificial one. The goal of the surgery is to relieve arm or neck pain caused by a compressed nerve or spinal cord, while preserving natural neck movement. The study aims to determine which implant design leads to better outcomes in terms of pain relief, neck function, and complication rates. You may be eligible if: - You are between 18 and 60 years old - You have cervical spondylotic myelopathy and/or radiculopathy (arm or hand pain/weakness) at a single level between C3 and C7, caused by disc herniation or degenerative disc disease - Your symptoms have not improved after at least 6 weeks of non-surgical treatment - You have decided to undergo cervical disc arthroplasty - You have signed an informed consent form You may NOT be eligible if: - You have had prior cervical spine surgery - You need surgery at more than two disc levels - You have a known allergy to metal alloys or polyethylene - You are morbidly obese - You have an active local or systemic infection - You have a psychiatric disorder, chronic alcohol or substance abuse, or another condition that would prevent you from completing follow-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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