Comparing two types of artificial discs for neck surgery
Comparison of Unconstrained and Semi-constrained Artificial Disc Implants Used in Cervical Disc Arthroplasty
This study is testing two different artificial discs for neck surgery to see which one helps people with neck problems feel better and move more easily after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | University of California, Los Angeles Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05701059 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are skeletally mature individuals aged 18 to 60 with cervical spondylotic myelopathy and/or radiculopathy unresponsive to conservative treatment.
Not a fit: Patients with prior cervical spine surgery, multiple diseased levels, or certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify which artificial disc implant provides better outcomes for patients undergoing cervical arthroplasty.
How similar studies have performed: While comparative studies on artificial disc implants are limited, previous research has shown promising outcomes for cervical arthroplasty, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.