[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04364295":3,"trial-entities:NCT04364295":85,"trial-summary:NCT04364295":89},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":44,"minimum_age":22,"maximum_age":22,"healthy_volunteers":15,"eligibility_criteria":45,"std_ages":55,"locations":59,"central_contacts":77,"overall_officials":78,"references":83,"see_also_links":84},"NCT04364295","SS-GR-1902","Stronger Together Global Registry","Evaluating Real-World Spine Outcomes for Spinal and Orthobiologics Products From Around the World","ENROLLING_BY_INVITATION","2028-08","2023-03","2023-04-04","2020-03-20","SeaSpine, Inc.","INDUSTRY",false,"A global, prospective, non-randomized, multicenter, observational, post-market, medical record review registry evaluating real-world evidence for SeaSpine products.","To gain observational, prospective, real-world clinical, and radiographic data in order to evaluate continued safety and performance following the implantation of SeaSpine products.",[19],"Spinal Disease",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},2285,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Spinal Surgery with SeaSpine product","Implanted with SeaSpine spinal or orthobiologic product",[33],"Implanted with SeaSpine spinal or orthobiologics product",[35],{"measure":36,"description":37,"timeFrame":38},"Evaluation of product failure","Product failure is defined as product fracture, loosening, gross migration and\u002For dissociation.","12 months post-operative",[40],{"measure":41,"description":42,"timeFrame":43},"Incidence of product-related Serious Adverse Events (SAEs) related to the spine, fusion or bone healing, and intraoperative and postoperative unanticipated adverse device effects","Product-related SAEs related to the spine, fusion, or bone will be collected for this outcome measure.","Intra-operative to 24 months","ALL",{"inclusion":46,"exclusion":51,"raw_text":54},[47,48,49,50],"Have been treated with at least one SeaSpine product.","Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.","Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.","Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.",[52,53],"Was not implanted with at least one SeaSpine product during operation","Any other condition that the Investigator determines is unacceptable for enrollment into this registry","Inclusion Criteria:\n\n* Have been treated with at least one SeaSpine product.\n* Have obtained radiographic imaging, as part of the standard of care, at the following time points: preoperative and postoperative.\n* Have obtained at least one preoperative patient-reported outcome measure, as part of the standard of care.\n* Patient is planned, per standard of care, to be assessed with radiographic imaging and consistent patient-reported outcome measure(s) from preoperative through at least two scheduled follow-up visits.\n\nExclusion Criteria:\n\n* Was not implanted with at least one SeaSpine product during operation\n* Any other condition that the Investigator determines is unacceptable for enrollment into this registry",[56,57,58],"CHILD","ADULT","OLDER_ADULT",[60,69],{"facility":61,"city":62,"state":63,"zip":64,"country":65,"geoPoint":66},"Spine Colorado","Durango","Colorado","81301","United States",{"lat":67,"lon":68},37.27528,-107.88007,{"facility":70,"city":71,"state":72,"zip":73,"country":65,"geoPoint":74},"OrthoNeuro","New Albany","Ohio","43054",{"lat":75,"lon":76},40.08117,-82.80879,[],[79],{"name":80,"affiliation":81,"role":82},"Frank Vizesi, PhD","SeaSpine Orthopedics Corporation","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":86,"biomarkers":88},[87],"Disorder of vertebral column",[],{"nct_id":4,"found":90,"summary":91,"prompt_version":101},true,{"design":92,"status":93,"heading":94,"summary":95,"follow_up":96,"word_count":97,"commitments":98,"compensation":99,"drugs_mentioned":100},"This is an observational study, meaning researchers will collect information from medical records rather than assigning treatments. It aims to include about 2285 participants.","completed","Stronger Together Global Registry for Spinal Disease","This is an observational study called the Stronger Together Global Registry. It's looking at how well SeaSpine spinal or orthobiologic products work in real-world settings after spinal surgery. Researchers want to see if these products fail within 12 months after surgery. You could be included if you've had spinal surgery using at least one SeaSpine product, have had standard pre- and post-operative X-rays or other imaging, and have completed at least one standard pre-operative patient-reported outcome measure (a survey about your health). The study is currently unclear on its recruitment status and plans to include about 2285 people.","The study evaluates product failure at 12 months post-operative.",98,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]