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Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

NCT05701059 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Cervical Spondylosis With Myelopathy
  • Cervical Radiculopathy
  • Cervical Disc Herniation
  • Degenerative Disc Disease

Interventions

PROCEDURE

Cervical 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.

DEVICE

Semi-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.

DEVICE

Unconstrained Biomet Zimmer Mobi-C

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

Sponsors & Collaborators

Principal Investigators

  • Daniel C Lu, MD, PhD · University of California, Los Angeles

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2026-07-01
Completion
2026-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05701059 on ClinicalTrials.gov