[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100493123":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":67,"collaborators":10,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":10,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":10,"studyType":83,"phases":10,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":51,"whyStopped":10,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Semi-Constrained Nuvasive Simplify",null,"This group will be undergoing cervical arthroplasty with the Nuvasive Simplify artificial disc implant. The Nuvasive Simplify implements a three-piece design with two endplates and a semi-constrained mobile core.",[13,14],"Procedure: Cervical arthroplasty","Device: Semi-Constrained Nuvasive Simplify",{"label":16,"type":10,"description":17,"interventionNames":18},"Unconstrained Biomet Zimmer Mobi-C","This group will be undergoing cervical arthroplasty with the Biomet Zimmer Mobi-C artificial disc implant. The Biomet Zimmer Mobi-C implements an unconstrained three piece design.",[13,19],"Device: Unconstrained Biomet Zimmer Mobi-C",[21,28,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Cervical arthroplasty","A joint replacement procedure administered by inserting an artificial disc between the vertebrae to replace a natural spinal disc after it has been removed.",[9,16],[27],"Cervical artificial disc replacement surgery",{"type":29,"name":9,"description":30,"armGroupLabels":31,"otherNames":10},"DEVICE","This weight-bearing implant consisting of PEEK (polyetheretherketone) endplates and one semi-constrained, fully articulating, mobile zirconia toughened alumina (ZTA) ceramic core will be administered by cervical arthroplasty into the specified single-level cervical region.",[9],{"type":29,"name":16,"description":33,"armGroupLabels":34,"otherNames":10},"This unconstrained, three-piece implant will be administered by cervical arthroplasty into the specified single-level cervical region.",[16],[36],{"name":37,"affiliation":5,"role":38},"Daniel C Lu, MD, PhD","PRINCIPAL_INVESTIGATOR",[40,44],{"name":37,"role":41,"phone":42,"phoneExt":10,"email":43},"CONTACT","(310) 267-2975","dclu@mednet.ucla.edu",{"name":45,"role":41,"phone":46,"phoneExt":10,"email":47},"Sandra Holley, PhD","310-267-1770","sholley@mednet.ucla.edu",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"UCLA","RECRUITING","Los Angeles","California","90095","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-118.24368,34.05223,{"lat":61,"lon":60},[64],{"name":65,"role":41,"phone":66,"phoneExt":10,"email":43},"Daniel C Lu, MD PhD","310-825-4321",{"type":38,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Daniel Lu, MD, PhD","Principal Investigator, Neuroplasticity and Repair Laboratory","100493123","comparison-of-artificial-disc-implants-in-cervical-disc-arthroplasty-100493123",false,"NCT05701059","Comparison of Artificial Disc Implants in Cervical Disc Arthroplasty","Comparison of Unconstrained and Semi-constrained Artificial Disc Implants Used in Cervical Disc Arthroplasty","Inclusion Criteria:\n\n* Patient is skeletally mature and between 18 to 60 years of age\n* Experiences cervical spondylotic myelopathy and\u002For radiculopathy typically caused by disc herniation or degenerative disc disease at a single level between C3 to C7\n* Is unresponsive to at least six weeks of non-surgical conservative care\n* Has the intention of undergoing cervical arthroplasty for their chief complaint\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Patient has had prior cervical spine surgery\n* Has more than two diseased levels requiring surgery\n* Has a known allergy to a metal alloy or polyethylene\n* Is morbidly obese\n* Has active local or system infection\n* 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.)","ALL","18 Years","60 Years",{"count":81,"type":82},20,"ESTIMATED","OBSERVATIONAL","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\u002For 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.",[86,87,88,89],"Cervical Spondylosis With Myelopathy","Cervical Radiculopathy","Cervical Disc Herniation","Degenerative Disc Disease",[91,92,93,94,95,96,97,98,99,100,101,102,103,104],"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","2026-02-10",{"date":107,"type":108},"2026-02-13","ACTUAL",{"date":110,"type":108},"2023-05-01",{"date":112,"type":82},"2026-12-01",{"name":5,"class":6},1]