Recruiting

Artificial Disc ImplantsComparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Sponsor:

UCLA

Code:

NCT05701059

Conditions

Cervical Spondylosis With Myelopathy

Cervical Radiculopathy

Cervical Disc Herniation

Degenerative Disc Disease

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Cervical arthroplasty

Semi-Constrained Nuvasive Simplify

Unconstrained Biomet Zimmer Mobi-C

Study Details

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 Spondylosis With Myelopathy

Cervical Radiculopathy

Cervical Disc Herniation

Degenerative Disc Disease

Study ID

NCT05701059

Start date

May 1, 2023

Status verified date

Feb, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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.)

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Unconstrained Biomet Zimmer Mobi-C

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

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 and Locations

Central contacts

Daniel C Lu, MD, PhD

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

Sandra Holley, PhD

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

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90095

Contacts

Daniel C Lu, MD PhD

310-825-4321 dclu@mednet.ucla.edu

More Information

Sponsor

University of California, Los Angeles

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, Los Angeles on 2026-02-13.