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

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCLA
RECRUITING
Los Angeles
Contact Information
Primary
Daniel C Lu, MD, PhD
dclu@mednet.ucla.edu
(310) 267-2975
Backup
Sandra Holley, PhD
sholley@mednet.ucla.edu
310-267-1770
Time Frame
Start Date: 2023-05-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
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.
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.
Sponsors
Leads: University of California, Los Angeles

This content was sourced from clinicaltrials.gov