[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657896":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":13,"studyPopulation":15,"armGroups":16,"interventions":22,"overallOfficials":13,"centralContacts":27,"locations":36,"responsibleParty":54,"collaborators":13,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":13,"enrollmentInfo":65,"targetDuration":13,"studyType":68,"phases":13,"briefSummary":69,"conditions":70,"keywords":13,"overallStatus":73,"whyStopped":13,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Patient satisfaction","Patient satisfaction will be assessed by administering the patient satisfaction scale of the Zurich Claudication Questionnaire at the final follow-up visit. Each patient's satisfaction threshold will be defined as a raw score of 2.5 or lower on the ZCQ patient satisfaction scale.","6 months",null,{"allocation":13,"interventionModel":13,"interventionModelDescription":13,"primaryPurpose":13,"observationalModel":6,"timePerspective":6,"maskingInfo":13},"Prospective and retrospective collection of data",[17],{"label":18,"type":13,"description":19,"interventionNames":20},"Facet arthroplasty with the TOPS™ system or the TOPS™ system + Versa-link™ system","prospective and retrospective collect data",[21],"Other: Questionnaire",[23],{"type":6,"name":24,"description":25,"armGroupLabels":26,"otherNames":13},"Questionnaire","Zurich claudication questionnaire : The Zurich Claudication Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment.",[18],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":13,"email":32},"Jean-François Oudet","CONTACT","0033683346567","jf.oudet@ecten.eu",{"name":34,"role":30,"phone":13,"phoneExt":13,"email":35},"Marie-Hélène Barba","mh.barba@ecten.eu",[37],{"facility":38,"status":13,"city":39,"state":13,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Clinique des Cèdres","Cornebarrieu","31700","France","FR",{"type":44,"coordinates":45},"Point",[46,47],1.32588,43.64967,{"lat":47,"lon":46},[50],{"name":51,"role":30,"phone":52,"phoneExt":13,"email":53},"Jean-Paul Lescure, Dr","0033562133369","jean-paul.lescure@orange.fr",{"type":55,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100657896","combined-analysis-of-retrospective-and-prospective-data-from-patients-who-underwent-facet-arthroplasty-with-the-tops-system-or-the-tops--versalink-fixation-system-at-a-single-center-100657896",false,"NCT07845344","Combined Analysis of Retrospective and Prospective Data From Patients Who Underwent Facet Arthroplasty With the TOPS™ System or the TOPS + Versalink™ Fixation System at a Single Center.","TOPS","Inclusion Criteria:\n\n* Male or female patient aged over 18 years,\n* All consecutively treated patients who underwent facet arthroplasty using the TOPS™ system or the TOPS™ system + VersaLink™ system at a single center, and for whom the surgery was performed at least 6 months prior to the start of data collection,\n* Patient who has received written information and has not objected to participating in the study,\n* Patient capable of understanding the study and answering the Zurich Claudication Questionnaire,\n* Patient affiliated with or a beneficiary of a social security scheme.\n\nExclusion Criteria:\n\n* Minor patient,\n* Patient treated consecutively who received the TOPS™ system or the TOPS™ system + Versalink™ fixation system at multiple surgical centers,\n* Patient refusal to participate in the study,\n* Protected patient: adult under guardianship, curatorship, or other legal protection; deprived of liberty by judicial or administrative decision,\n* Pregnant, breastfeeding, or recently delivered woman.","ALL","18 Years",{"count":66,"type":67},200,"ESTIMATED","OBSERVATIONAL","The TOPS™ system is an alternative to spinal fusion designed to stabilize-rather than fuse-the affected vertebral level, thereby relieving pain caused by degenerative spondylolisthesis and spinal stenosis. Degenerative spondylolisthesis involves abnormal, excessive vertebral movement, resulting in lower back and leg pain.\n\nSpinal stenosis is a condition in which nerve compression causes symptoms such as pain, numbness, and tingling in the legs. The TOPS system is intended to provide stabilization for skeletally mature patients with single-level disease (L3-L5) who have not achieved sufficient symptom relief through prior conservative care. The Total Posterior Spine System (\"TOPS™ system\") received CE marking and has been commercially available since 2012; it also received US FDA approval in June 2023.\n\nThe Versalink™ fixation system is a bilateral titanium lumbar fusion system designed for use with a titanium cross-link as a standalone fusion device. It is also designed to connect above or below the TOPS™ device to form a hybrid construct.\n\nThe TOPS system is designed to restore lumbar spine stability while allowing for spinal canal decompression (laminectomy\u002Ffacetectomy).\n\nBy using the TOPS™ system, the surgeon can remove pathological bony elements and implant a posterior spine replacement technology that effectively recreates load-bearing dynamics and spinal biomechanics, thereby preserving mobility in the treated segment.",[71,72],"Spinal Stenosis","Bilateral Lumbar Arthrodesis","NOT_YET_RECRUITING","2026-09-21",{"date":76,"type":77},"2026-09-28","ACTUAL",{"date":79,"type":67},"2026-10-30",{"date":81,"type":67},"2027-11-30",{"name":5,"class":6},1]