[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653724":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":84,"studyPopulation":88,"armGroups":89,"interventions":95,"overallOfficials":84,"centralContacts":84,"locations":102,"responsibleParty":121,"collaborators":84,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":84,"enrollmentInfo":132,"targetDuration":84,"studyType":135,"phases":84,"briefSummary":136,"conditions":137,"keywords":84,"overallStatus":105,"whyStopped":84,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Cousin Biotech","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":84},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical success rate at long term (at least 9 years)","The clinical success is defined by :\n\n* An improvement (decrease) in the ODI score of at least 30% compared to the score at enrollment in the pivotal study\n* No complications such as revision, reoperation, implant removal, infection, or any other adverse events related to the surgery or the device since enrollment in the pivotal study","At least 9 years after enrollment in the pivotal study",[14,17,20,23,26,29,32,35,38,41,44,47,50,54,58,61,64,68,72,75,78,81],{"measure":15,"description":16,"timeFrame":12},"Degree of functional disability","The degree of functional disability associated with low back pain will be measured using the Oswestry Disability Index (ODI), a 0-100 scale in which higher scores indicate greater functional disability.",{"measure":18,"description":19,"timeFrame":12},"Radicular and low back pain","The severity of radicular and lower back pain will be assessed using a Visual Analog Scale (VAS), ranging from 0 to 100, with higher scores indicating greater pain severity.",{"measure":21,"description":22,"timeFrame":12},"Walking time","Walking time will be estimated by measuring the time it takes to cover the maximum possible distance",{"measure":24,"description":25,"timeFrame":12},"Finger-to-floor test","The finger-to-floor test measures the distance between your fingers and the floor: With your feet together, slowly lean your upper body forward while arching your back, keeping your arms straight, and try to touch the floor with your fingers. It is essential not to bend your knees",{"measure":27,"description":28,"timeFrame":12},"Disc height (anterior and posterior)","Disc height (anterior and posterior) will be measured based on the MRI results",{"measure":30,"description":31,"timeFrame":12},"Mobility of the highest treated level and the adjacent level","The mobility of the highest treated level and the adjacent level will be measured by dynamic radiography in lateral flexion and extension. Mobility will be calculated as the angular difference between extension and flexion, based on the angles formed by the tangents to the superior and inferior endplates of the vertebral segment.",{"measure":33,"description":34,"timeFrame":12},"Pfirmann and Modic classification","The Pfirmann and Modic classification (affected level and adjacent level) based on MRI results",{"measure":36,"description":37,"timeFrame":12},"Patient satisfaction","Patient satisfaction with their INTRASPINE implant will be assessed on a 4-point scale: (1: Very satisfied, 2: Satisfied, 3: Somewhat dissatisfied, 4: Not at all satisfied)",{"measure":39,"description":40,"timeFrame":12},"Number of Participants with Adjacent Syndrome","A patient is considered to have an adjacent syndrome at their follow-up visit if they meet one (or more) of these three criteria:\n\n* Radiological adjacent syndrome: This diagnosis will be made for any patient who meets the following criteria, as measured by dynamic X-ray and MRI\n* Symptomatic adjacent segment syndrome: is diagnosed when clinical symptoms such as radicular pain or intermittent claudication worsen postoperatively and the causative lesion is confirmed to be the adjacent segment to the treated level (on MRI).\n* Surgical adjacent syndrome: is defined as a symptomatic adjacent syndrome for which surgery is necessary to treat neurological deterioration at the adjacent degenerative segment.",{"measure":42,"description":43,"timeFrame":12},"Reoperation rate","A reoperation is defined as a secondary procedure at the implant site for any reason (infectious or mechanical): revision, removal of the implant (explantation), fusion, the need for additional fixation, or any procedure involving any part of the device or one of its complications",{"measure":45,"description":46,"timeFrame":12},"Implant migration","Migration is defined as the displacement of the entire implant relative to its initial position: Migration is considered to have occurred if there is a deviation of more than 3 mm from the baseline measurement. This measurement is based on the MRI results.",{"measure":48,"description":49,"timeFrame":12},"Implant wear measurement","Measurement taken between the anterior tip of the wedge and the posterior vertebral wall based on MRI results",{"measure":51,"description":52,"timeFrame":53},"Number of Participants with Recurrent Herniated Disc","A recurrence of a herniated disc is defined as the onset of a herniated disc confirmed by imaging or following surgery at the same instrumented level in a patient who has undergone surgery. This definition allows for the inclusion of all herniations (both symptomatic and asymptomatic).","From enrollment in the pivotal study through the long-term follow-up assessment (at least 9 years)",{"measure":55,"description":56,"timeFrame":57},"Number and Rate of Adverse Events and Serious Adverse Events","The number and rate of adverse events (AEs) and serious adverse events (SAEs) reported since the 3-year follow-up visit, classified by nature and by organ system","From the 3-year follow-up visit through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study)",{"measure":59,"description":60,"timeFrame":12},"Overall Sagittal Alignment","Overall sagittal alignment will be assessed using full-spine radiography (teleradiography or EOS) at long-term follow-up.",{"measure":62,"description":63,"timeFrame":57},"Number of device malfunctions","The number of device malfunctions (DM) reported since the 3-year follow-up visit",{"measure":65,"description":66,"timeFrame":67},"Complications","The rate of intraoperative and short- and long-term postoperative complications","From the index surgery through the long-term follow-up assessment (at least 9 years after enrollment in the pivotal study)",{"measure":69,"description":70,"timeFrame":71},"Lumbar Lordosis","Lumbar lordosis (LL) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.","At least 9 years after enrollment in the pivotal stud",{"measure":73,"description":74,"timeFrame":12},"Segmental Lordosis at the Treated Level","Segmental lordosis (LS) at the instrumented (treated) level will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up",{"measure":76,"description":77,"timeFrame":12},"Pelvic Incidence","Pelvic incidence (PI) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up",{"measure":79,"description":80,"timeFrame":12},"Sacral Slope","Sacral slope (SS) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up",{"measure":82,"description":83,"timeFrame":12},"Pelvic Version","Pelvic version (PV) will be measured using full-spine radiography (teleradiography or EOS) at long-term follow-up.",null,{"allocation":84,"interventionModel":84,"interventionModelDescription":84,"primaryPurpose":84,"observationalModel":86,"timePerspective":87,"maskingInfo":84},"COHORT","PROSPECTIVE","The study population included adult patients from the Princeps study (INTREUR) who completed the 36-month follow-up. Eligible patients had degenerative lumbar disc disease at one or two levels, underwent IntraSPINE® implantation following failure of conservative treatment, and had no device removal during follow-up or underwent replacement with a new IntraSPINE® device at the 36-month visit. All patients received study information and provided written informed non-opposition.",[90],{"label":91,"type":84,"description":92,"interventionNames":93},"IntraSPINE","The IntraSPINE® implant is a widely used dynamic interlaminar stabilization device that differs from other inter-spinal devices (ISDs) in its structure and its more anterior positioning relative to the spinal axis.\n\nThis device is a dimethyl siloxane (silicone) implant covered with a polyethylene terephthalate mesh. Its anterior surface, which comes into contact with the ligamentum flavum (when it is left in place) or with the dura mater, is coated with an anti-adhesive coating.\n\nThe device is an elastic support with a cushioning effect. The stiffer anterior portion provides strong distraction, while the more flexible posterior tunnel acts as a stress absorber. The lateral wings secure the device in place, preventing any migration.",[94],"Drug: IntraSPINE",[96],{"type":97,"name":91,"description":98,"armGroupLabels":99,"otherNames":100},"DRUG","Intraspine is an interlaminar device not interspinous.",[91],[101],"Interlaminar device",[103],{"facility":104,"status":105,"city":106,"state":84,"zip":84,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":115},"Maison des consultations","RECRUITING","Saran","France","FR",{"type":110,"coordinates":111},"Point",[112,113],1.87601,47.95013,{"lat":113,"lon":112},[116],{"name":117,"role":118,"phone":119,"phoneExt":84,"email":120},"Doan Co Minh","CONTACT","+33 02 46 91 51 10","m.collet@cousin-surgery.com",{"type":122,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR","100653724","long-term-evaluation-of-the-performance-and-safety-of-the-intraspine-interlaminar-implant-in-the-treatment-of-lumbar-degenerative-disc-disease-100653724",false,"NCT07790328","Long-Term Evaluation of the Performance and Safety of the IntraSPINE® Interlaminar Implant in the Treatment of Lumbar Degenerative Disc Disease","IntraLT","Inclusion Criteria:\n\n* Adult patient,\n* Patient with degenerative lumbar disc disease at one or two levels for whom\n* Surgery involving the placement of an IntraSPINE® implant has been indicated following the failure of conservative treatment,\n* Patient who has read and signed the information and consent form\n\nExclusion Criteria:\n\n* Patients with the following contraindications:\n* Allergy to any of the components,\n* Infected site,\n* Pregnant women.\n* Patients with spondylolisthesis with isthmic lysis","ALL","18 Years",{"count":133,"type":134},50,"ESTIMATED","OBSERVATIONAL","This is an observational study designed as an extension of a prospective study conducted between 2012 and 2017. Patients who were originally enrolled in the initial study are being recontacted for follow-up assessment, including evaluation of clinical and radiological (MRI) criteria. Approximately 50 patients have been included to date and their long terms results (at least 9 years) will be assessed.",[138,139,140,141],"Lower Back Pain of Disc Origin","Joint Facet Syndrome","Lumbar Canal Stenosis","Spinal Disease","2026-08-24",{"date":144,"type":145},"2026-08-27","ACTUAL",{"date":147,"type":145},"2020-07-28",{"date":149,"type":134},"2031-06-01",{"name":5,"class":6},1]