Comparing two types of artificial discs for neck surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the outcomes of two FDA-approved artificial disc implants, Biomet Zimmer Mobi-C and Nuvasive Simplify, used in cervical arthroplasty for conditions like cervical spondylotic myelopathy and radiculopathy. Participants aged 18 to 60, who have not responded to conservative treatment, will be randomly assigned to receive one of the implants. The study will assess various outcomes, including neck disability, quality of life, pain levels, and range of motion, through baseline and follow-up evaluations at three months, six months, and one year post-surgery. This comparative analysis aims to provide insights into the effectiveness of these different implant designs.

Why it matters

Who can join: the full rules

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.)

Where it's running

• UCLA
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Daniel C Lu, MD, PhD — University of California, Los Angeles
• Study coordinator: Daniel C Lu, MD, PhD
• Email: dclu@mednet.ucla.edu
• Phone: (310) 267-2975

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.