Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Launched by UNIVERSITY OF CALIFORNIA, LOS ANGELES · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of artificial discs used to treat neck problems caused by conditions like herniated discs or degenerative disc disease. The two devices being compared are the Biomet Zimmer Mobi-C and the Nuvasive Simplify. Researchers want to see how well each disc helps improve neck pain, disability, and overall quality of life for patients. Participants in the study will be randomly assigned to receive one of the two implants and will be monitored for about a year and a half to assess their recovery and progress.

To be eligible for the trial, participants should be between 18 and 60 years old, have been diagnosed with neck issues that haven't improved with at least six weeks of non-surgical treatments, and plan to undergo surgery for their condition. Those with previous neck surgeries, serious obesity, or certain medical conditions that could affect their ability to participate will not be included. Participants can expect to undergo several assessments before and after their surgery to help evaluate their recovery. This trial is currently recruiting patients, so if you or someone you know might be interested, it could be a good opportunity to help advance treatment options for neck conditions.

Gender

ALL

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.)