Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

NCT ID: NCT05701059

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2025-12-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Cervical arthroplasty

Intervention Type: 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

Intervention Type: 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

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.

Cervical arthroplasty

Intervention Type: 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.

Unconstrained Biomet Zimmer Mobi-C

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DEVICE

Unconstrained Biomet Zimmer Mobi-C

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

Intervention Type: DEVICE

Other Intervention Names

Cervical artificial disc replacement surgery

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Patient has had prior cervical spine surgery
• Has more than two diseased levels requiring surgery
• Has a known allergy to a metal alloy or polyethylene
• Is morbidly obese
• Has active local or system infection
• Has any circumstances or conditions such that their ability to provide informed consent comply with follow-up requirements, or provide self-assessments is compromised (eg: psychiatric disorders, chronic alcohol or substance abuse, etc.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Daniel Lu, MD, PhD

Principal Investigator, Neuroplasticity and Repair Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniel C Lu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

UCLA

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Daniel C Lu, MD, PhD

Role: CONTACT

dclu@mednet.ucla.edu

(310) 267-2975

Sandra Holley, PhD

Role: CONTACT

sholley@mednet.ucla.edu

310-267-1770

Facility Contacts

Daniel C Lu, MD PhD

Role: primary

dclu@mednet.ucla.edu

310-825-4321

Other Identifiers

22-001808

Identifier Type: -

Identifier Source: org_study_id