[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478314":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":139,"collaborators":20,"id":141,"slug":20,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":20,"enrollmentInfo":149,"targetDuration":20,"studyType":152,"phases":153,"briefSummary":155,"conditions":156,"keywords":159,"overallStatus":94,"whyStopped":20,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":175},{"fullName":5,"class":6},"Spinal Stabilization Technologies","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lumbar Disc Nucleus Replacement","EXPERIMENTAL","All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.",[13],"Device: PerQdisc Nucleus Replacement System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PerQdisc Nucleus Replacement System","Lumbar spine disc nucleus replacement system. All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Michael Hess, MD","London Spine Clinic\u002FATOS-Klinik","STUDY_CHAIR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Maren Lange","CONTACT","8004841588","mlange@sstspine.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Molly Bond","1 (715) 577-7527","mbond@sstspine.com",[37,49,54,63,69,74,83,92,111,127],{"facility":38,"status":39,"city":40,"state":41,"zip":20,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"CIGE: Centro de Imunologia y Genetica","ACTIVE_NOT_RECRUITING","Medellín","Antioquia","Colombia",{"type":44,"coordinates":45},"Point",[46,47],-75.57151,6.245,{"lat":47,"lon":46},{"facility":50,"status":39,"city":40,"state":41,"zip":20,"country":42,"cosmosGeoPoint":51,"geoPoint":53,"contacts":20},"Fundacion Hospitalaria San Vicente de Paul",{"type":44,"coordinates":52},[46,47],{"lat":47,"lon":46},{"facility":55,"status":39,"city":56,"state":57,"zip":20,"country":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":20},"Cediul S.A.","Barranquilla","Atlántico",{"type":44,"coordinates":59},[60,61],-74.78132,10.96854,{"lat":61,"lon":60},{"facility":64,"status":65,"city":56,"state":57,"zip":20,"country":42,"cosmosGeoPoint":66,"geoPoint":68,"contacts":20},"Fundación Campbell","WITHDRAWN",{"type":44,"coordinates":67},[60,61],{"lat":61,"lon":60},{"facility":70,"status":65,"city":56,"state":57,"zip":20,"country":42,"cosmosGeoPoint":71,"geoPoint":73,"contacts":20},"Sabbag Radiólogos S.A.",{"type":44,"coordinates":72},[60,61],{"lat":61,"lon":60},{"facility":75,"status":39,"city":76,"state":77,"zip":20,"country":42,"cosmosGeoPoint":78,"geoPoint":82,"contacts":20},"Sociedad de Cirugia de Bogota- Hospital de San Jose","Bogotá","D.C.",{"type":44,"coordinates":79},[80,81],-74.08175,4.60971,{"lat":81,"lon":80},{"facility":84,"status":39,"city":85,"state":86,"zip":20,"country":42,"cosmosGeoPoint":87,"geoPoint":91,"contacts":20},"Clínica Imbanaco de Cali S.A.","Cali","Valle del Cauca Department",{"type":44,"coordinates":88},[89,90],-76.5199,3.43054,{"lat":90,"lon":89},{"facility":93,"status":94,"city":95,"state":96,"zip":20,"country":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Pacífica Salud Hospital Punta Pacífica","RECRUITING","Panama City","Provincia de Panamá","Panama",{"type":44,"coordinates":99},[100,101],-79.51973,8.9936,{"lat":101,"lon":100},[104,108],{"name":105,"role":29,"phone":106,"phoneExt":20,"email":107},"C&M Research S.A.","+507 6860-4953","info@candmresearch.org",{"name":109,"role":110,"phone":20,"phoneExt":20,"email":20},"Dr. Ricardo Bermudez, MD","PRINCIPAL_INVESTIGATOR",{"facility":112,"status":94,"city":113,"state":20,"zip":114,"country":115,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Sanatario Americano","Asunción","1101","Paraguay",{"type":44,"coordinates":117},[118,119],-57.647,-25.28646,{"lat":119,"lon":118},[122,125],{"name":123,"role":29,"phone":20,"phoneExt":20,"email":124},"Carlos Cetraro","radiosolutionspy@gmail.com",{"name":126,"role":110,"phone":20,"phoneExt":20,"email":20},"Francisco Duarte, MD",{"facility":128,"status":94,"city":129,"state":20,"zip":20,"country":130,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Republican Specialized Scientific Practical Medical Center of Endocrinology named after Academician Y.Kh. Turakulova","Tashkent","Uzbekistan",{"type":44,"coordinates":132},[133,134],69.21627,41.26465,{"lat":134,"lon":133},[137],{"name":138,"role":110,"phone":20,"phoneExt":20,"email":20},"Dr. Abdufarrukh Karimov",{"type":140,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100478314",false,"NCT05508360","\"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy\" (LOPAIN2)","LOPAIN2","Inclusion Criteria:\n\n* Patient is skeletally mature aged 22-70.\n* Patient has Degenerative Disc Disease (DDD) at one or more levels between L1 and S1 but the discogenic pain must be limited to a single level.\n* Patient has adequate disc height (6mm) at the level to be treated\n* Patient has exhausted a minimum of 6 months of conservative treatment for their back (e.g. physical therapy, medications, injections, life style changes, etc).\n* Patient has a preoperative Oswestry Disability questionnaire score ≥ 40 out of 100 points (40\u002F100)\n* Patient has a low back pain Visual Analog Scale (VAS) ≥ 40 mm (4 cm)\n* Patient has signed the approved Informed Consent Form.\n* All surgeries must be approved by the Medical Advisory Board (MAB)\n\nExclusion Criteria:\n\n* Patient has less than 6 mm of disc height.\n* Patient has had prior lumbar spine surgery (nucleoplasty at non-index level is considered acceptable).\n* Patient has had spinal fusion in the lumbar or thoracic intervertebral spaces. Cervical fusion is allowed as long as there are no neurologic deficits in the lower extremities.\n* Patient has spondyloarthropathy or other spondylolisthesis greater than 2 mm.\n* Patient has congenital moderate or severe spinal stenosis or epidural lipomatosis.\n* Patient has significant facet disease. Significant is defined as pain improvement of 80% or more following image-guided medial branch blocks of the target level according to SIS guidelines (diagnostic, contrast controlled).\n* Patient has any known active malignancy.\n* Patient has previously undergone or currently on immunosuppressive therapy. Steroids used to treat inflammation are allowed.\n* Patient has active or local systemic infection.\n* Patient has been diagnosed with hepatitis, rheumatoid arthritis, lupus erythematosus, or other autoimmune disease including AIDS, ARC and HIV.\n* Patient has diabetes mellitus (Type 1 or 2) requiring daily insulin management.\n* Patient has osteopenia of the spine (T-score of -1.0 or lower). A DEXA scan should be performed to rule out patients considered at risk for osteopenia.\n* Patient has morbid obesity defined as a body mass index (BMI) more than 40 or a weight of more than 45 kg (100 lbs.) over ideal body weight.\n* Patient has a known allergy to silicone or barium sulfate.\n* Patient has a significant disc herniation at the level to be treated. Significant is defined as a large, extruded herniation that creates a risk for expulsion.\n* Patient has a significant Schmorl's node in the level to be treated. Significant is defined as a large, rectangular or irregular shaped node that has an associated active inflammatory process (Modic I changes).\n* Patient has motion of less than 3 degrees on pre-operative lateral flexion\u002Fextension radiographs.\n* Patient belongs to a vulnerable population or has a condition such that his\u002Fher ability to provide informed consent, comply with follow-up requirements, or provide self-assessments is compromised (e.g. developmentally, disabled, prisoner, chronic alcohol\u002F substance abuser)\n\nIntraoperative Exclusion Criteria:\n\n* Protrusion of the 20A Imaging Balloon up to or beyond the outer margin of the vertebra during the imaging steps.\n* Patient has a violated endplate as determined by imaging balloons during fluoroscopy.\n* Patient has a disc space that is too narrow for implantation. MIPL Specific\n* Poor radiological visualization of Kambin's triangle.\n* Sustained irritation of the exiting nerve root during any aspect of the annular dilation technique (leg movement or if performing with electrical monitoring) in spite or repositioning instruments.","ALL","22 Years",{"count":150,"type":151},72,"ESTIMATED","INTERVENTIONAL",[154],"NA","This study will be a prospective, open-label, multi-center study including 72 patients that will collect additional safety and efficacy data for the Spinal Stabilization Technologies PerQdisc Nucleus Replacement System.",[157,158],"Degenerative Disc Disease","Chronic Low-back Pain",[157,160,161,162,163,164,165],"DDD","Chronic Low Back Pain","cLBP","Disc Herniation","Nucleus Replacement","Low Back Pain","2026-05-25",{"date":168,"type":169},"2026-05-27","ACTUAL",{"date":171,"type":169},"2022-08-22",{"date":173,"type":151},"2030-08-22",{"name":5,"class":6},10]