[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545595":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":60,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":10,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":10,"enrollmentInfo":74,"targetDuration":10,"studyType":77,"phases":10,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Synergy Spine Solutions","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prospective",null,"All patients for whom the decision has been made to have the Synergy Disc system implanted and give informed consent will be enrolled in this study, following country-specific requirements.",[13],"Device: Synergy Cervical Disc system",{"label":15,"type":10,"description":16,"interventionNames":17},"Retrospective","Patients who have previously received the Synergy Disc system in the last ten years are eligible for inclusion in the retrospective data collection; a waiver of consent, or an informed consent, for the retrospective data collection from the medical records of the implanting surgeon will be sought per country-specific regulations.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","Synergy Cervical Disc system","motion preservation disc",[9,15],[25],{"name":26,"affiliation":5,"role":27},"Robyn M Capobianco, PhD","STUDY_DIRECTOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Robyn Capobianco, PhD","CONTACT","(720) 787-9063","rcapobianco@synergyspinesolutions.com",{"name":35,"role":31,"phone":10,"phoneExt":10,"email":36},"Stacy Gardner","sgardner@mcra.com",[38],{"facility":39,"status":40,"city":41,"state":10,"zip":10,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Mater Misericordiae University Hospital","RECRUITING","Dublin","Ireland","IE",{"type":45,"coordinates":46},"Point",[47,48],-6.24889,53.33306,{"lat":48,"lon":47},[51,54,57],{"name":52,"role":31,"phone":10,"phoneExt":10,"email":53},"Jake McDonnell, MD","jackmcdonnell@rcsi.ie",{"name":55,"role":56,"phone":10,"phoneExt":10,"email":10},"Joseph Butler, MD","PRINCIPAL_INVESTIGATOR",{"name":58,"role":59,"phone":10,"phoneExt":10,"email":10},"Stacy Darwish, MD","SUB_INVESTIGATOR",{"type":61,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[63],{"name":64,"class":6},"MCRA","100545595","real-world-data-collection-on-the-synergy-disc-100545595",false,"NCT06383949","Real World Data Collection on the Synergy Disc","A Single Site Post-Market Data Collection Protocol to Evaluate the Performance of Synergy Spine Solutions Synergy Disc®","Inclusion Criteria:\n\nAge 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature patients for reconstruction of the disc from C3-C7 following a single or multiple level discectomy for intractable radiculopathy\n\nIntractable radiculopathy and\u002For myelopathy with at least one of the following producing symptomatic nerve root and\u002For spinal cord compression:\n\nherniated disc and\u002For osteophyte formation Symptomatic nerve root and\u002For spinal cord compression documented by patient history (arm or neck pain and\u002For neurologic deficit) and imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written informed consent given by subject.\n\nExclusion Criteria:\n\nModerate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or infection at the operative site Pregnancy Marked cervical instability on lateral, coronal, or flexion\u002Fextension radiographs Cervical spine condition other than symptomatic cervical disc disease requiring surgical treatment at the involved level Severe pathology of the facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and people without mental capacity)-","ALL","21 Years",{"count":75,"type":76},50,"ESTIMATED","OBSERVATIONAL","This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.",[80],"Cervical Degenerative Disc Disease",[82,83,84,85],"radiculopathy","myelopathy","disc replacement","motion preservation","2026-01-08",{"date":88,"type":89},"2026-01-09","ACTUAL",{"date":91,"type":89},"2024-08-06",{"date":93,"type":76},"2033-02-23",{"name":5,"class":6},1]