NCT05701059 Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty
| NCT ID | NCT05701059 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Cervical Spondylosis With Myelopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-05-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-05-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.)
Contact & Investigator
Daniel C Lu, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05701059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Cervical Spondylosis With Myelopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05701059 currently recruiting?
Yes, NCT05701059 is actively recruiting participants. Contact the research team at dclu@mednet.ucla.edu for enrollment information.
Where is the NCT05701059 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05701059 clinical trial?
NCT05701059 is sponsored by University of California, Los Angeles. The principal investigator is Daniel C Lu, MD, PhD at University of California, Los Angeles. The trial plans to enroll 20 participants.