Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Overseen By Sandra Holley, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Disqualifiers: Prior cervical surgery, Morbid obesity, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Daniel C Lu, MD, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline testing conducted to evaluate neck disability, quality of life, pain, physiological outcome, and neck range-of-motion

1 day

1 visit (in-person)

Surgery and Initial Recovery

Participants undergo cervical arthroplasty with either the Nuvasive Simplify or Biomet Zimmer Mobi-C artificial disc implant

1-2 weeks

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness with assessments at 3 months, 6 months, and 1 year post-operation

1 year

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Biomet Zimmer Mobi-C
• Nuvasive Simplify

How Is the Trial Designed?

Group I: Unconstrained Biomet Zimmer Mobi-C Experimental Treatment 2 Interventions

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.

Group II: Semi-Constrained Nuvasive Simplify Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+