Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of California, Los Angeles
Study ID
NCT05701059
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cervical arthroplasty — PROCEDURE
    A joint replacement procedure administered by inserting an artificial disc between the vertebrae to replace a natural spinal disc after it has been removed.
  • Semi-Constrained Nuvasive Simplify — DEVICE
    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.
  • Unconstrained Biomet Zimmer Mobi-C — DEVICE
    This unconstrained, three-piece implant will be administered by cervical arthroplasty into the specified single-level cervical region.

Study Details

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.

Key Dates

Start date
May 1, 2023
Status verified
Feb 2026
Primary completion
Jul 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: Semi-Constrained Nuvasive Simplify
    This group will be undergoing cervical arthroplasty with the Nuvasive Simplify artificial disc implant. The Nuvasive Simplify implements a three-piece design with two endplates and a semi-constrained mobile core.
  • Arm: Unconstrained Biomet Zimmer Mobi-C
    This group will be undergoing cervical arthroplasty with the Biomet Zimmer Mobi-C artificial disc implant. The Biomet Zimmer Mobi-C implements an unconstrained three piece design.

Primary Outcome Measure

Cervical range of motion assessments with VICON [ Time Frame: Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLALos AngelesCalifornia90095
Daniel C Lu, MD PhD
[email protected]
310-825-4321

Find similar trials in Los Angeles, CA

By research site
UCLA· Los Angeles, CA

Related Studies