NCT05701059

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In cases where surgery is indicated, treatment for cervical spondylotic myelopathy and/or radiculopathy (typically caused by disc herniation or degenerative disc disease) has traditionally been performed by a procedure known as anterior cervical discectomy and fusion (ACDF) to treat a damaged disc in the neck area of the spine. However, medical advancement in this field has allowed for a new procedure often referred to as cervical arthroplasty that implements artificial disc implantation. These implants mimic the function and structure of discs by cushioning the neck's vertebral bones instead of fusing them and providing flexibility for head movements. The emergence of different artificial disc implants that are structurally and mechanistically different calls for a comparative analysis that evaluates performance across a comprehensive set of patient outcomes. 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. This study has significant implications in better assessing the overall efficacy of cervical arthroplasty while providing insight to the differences in outcomes based on the artificial disc implanted. Findings can also contribute to characterizing the advantages and disadvantages of both implants to aid surgeons in making more informed and personalized treatment recommendations according to the needs of the patient.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-01
• Primary completion: 2026-07-01
• Completion: 2026-12-01
• First posted: 2023-01-27
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study