RECRUITING

Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of Unconstrained and Semi-constrained Artificial Disc Implants Used in Cervical Disc Arthroplasty

Quick Facts

Study Start:2023-05-01
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05701059

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient is skeletally mature and between 18 to 60 years of age
  2. * Experiences cervical spondylotic myelopathy and/or radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7
  3. * Is unresponsive to at least six weeks of non-surgical conservative care
  4. * Has the intention of undergoing cervical arthroplasty for their chief complaint
  5. * Signed informed consent form
  1. * Patient has had prior cervical spine surgery
  2. * Has more than two diseased levels requiring surgery
  3. * Has a known allergy to a metal alloy or polyethylene
  4. * Is morbidly obese
  5. * Has active local or system infection
  6. * 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.)

Contacts and Locations

Study Contact

Mark T Yamamoto, BS
CONTACT
4245359634
mtyamamoto@mednet.ucla.edu
Daniel C Lu, MD, PhD
CONTACT
(310) 319-3475
dclu@mednet.ucla.edu

Principal Investigator

Daniel C Lu, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Mark T Yamamoto, BS
STUDY_DIRECTOR
University of California, Los Angeles

Study Locations (Sites)

UCLA
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Daniel C Lu, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Mark T Yamamoto, BS, STUDY_DIRECTOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-01
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2023-05-01
Study Completion Date2024-12-01

Terms related to this study

Keywords Provided by Researchers

  • cervical
  • spondylosis
  • myelopathy
  • radiculopathy
  • disc
  • cervical disc
  • artificial disc
  • artificial disc implantation
  • cervical arthroplasty
  • disc herniation
  • degenerative disc disease
  • ACDF
  • Biomet Zimmer Mobi-C
  • Nuvasive Simplify

Additional Relevant MeSH Terms

  • Cervical Spondylosis With Myelopathy
  • Cervical Radiculopathy
  • Cervical Disc Herniation
  • Degenerative Disc Disease