Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

NCT05701059 | Recruiting FDA Device

• 1 other identifier: 22-001808
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cervical; spondylosis; myelopathy; radiculopathy; disc; cervical disc; artificial disc; artificial disc implantation; cervical arthroplasty; disc herniation; degenerative disc disease; ACDF; Biomet Zimmer Mobi-C; Nuvasive Simplify

Outcome Measures

Primary Outcomes (1)

• Cervical range of motion assessments with VICON

  Will measure flexion/extension, lateral bending, rotation, protraction/retraction in degrees. The outcome will reflect any improvement in physiological neck range of motion be patients undergoing this procedure.

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

Secondary Outcomes (10)

• Questionnaires on neck disability

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

• Neurological examination: gait assessment

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

• Neurological examination: foraminal compression test

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

• Radiographic assessments: disc height

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

• Radiographic assessments: disc angle

  Will be conducted before surgery (baseline), and 3 months, 6 months, and 1 year post-operation.

Study Arms (2)

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.

Procedure: Cervical arthroplasty; Device: Semi-Constrained Nuvasive Simplify

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.

Procedure: Cervical arthroplasty; Device: Unconstrained Biomet Zimmer Mobi-C

Interventions

Unconstrained Biomet Zimmer Mobi-C DEVICE

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

Unconstrained Biomet Zimmer Mobi-C

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.

Semi-Constrained Nuvasive Simplify

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.

Also known as: Cervical artificial disc replacement surgery

Semi-Constrained Nuvasive Simplify; Unconstrained Biomet Zimmer Mobi-C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Subjects must be experiencing cervical spondylotic myelopathy and/or radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7 after being unresponsive to at least six weeks of non-surgical conservative care. This study is for patients who have the intention of undergoing cervical arthroplasty and have already been recommended to do so by a doctor.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Radiculopathy; Intervertebral Disc Degeneration; Spondylosis; Spinal Cord Diseases; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Central Nervous System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel C Lu, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Lu, MD, PhD

CONTACT

(310) 267-2975; dclu@mednet.ucla.edu

Sandra Holley, PhD

CONTACT

310-267-1770; sholley@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Neuroplasticity and Repair Laboratory

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 27, 2023
• Study Start: May 1, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)