[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07207187":3,"trial-entities:NCT07207187":109,"trial-summary:NCT07207187":112},{"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":23,"primary_purpose":15,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":34,"sex":49,"minimum_age":50,"maximum_age":15,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":68,"locations":71,"central_contacts":105,"overall_officials":106,"references":107,"see_also_links":108},"NCT07207187","TSN-2025-SEK","Karma Ambispective Study","An Ambispective Efficacy Evaluation of the Karma Fixation System","ENROLLING_BY_INVITATION","2026-01","2025-09","2025-10-03","2025-03-06","Spinal Elements","INDUSTRY",null,"The purpose of this observational, multi-center, ambispective study is collect real world patient outcomes that characterize the effectiveness of the Karma Fixation System in the lumbar spine.","This is a multicenter, observational, ambispective study of up to 100 patients across a maximum of 10 US sites. Retrospective data collection will be performed from preoperative up to the single prospective visit. Prospective data collection will include a one-time visit to obtain post-operative imaging. In the event a subject has a complete 12-month data set available retrospectively, the prospective visit may not be required.\n\nPRIMARY ENDPOINTS:\n\n\\- Fusion status at a minimum of 12-months postoperative (≥10 months post surgery)\n\nSECONDARY ENDPOINTS:\n\n* Procedure-or device-related serious adverse events (SAE)\n* Patient reported outcomes if available included, Oswestry Disability Index (ODI), Back and leg pain as measured by Visual Analog Scale (VAS), 12-Item Short Form Health Survey (SF-12)",[19],"Subjects Treated With Karma Fixation System as Part of Their Spine Surgery",[21,22],"Degenerative spine","Karma","OBSERVATIONAL",[],{"count":26,"type":27},100,"ESTIMATED",[],[30],{"measure":31,"description":32,"timeFrame":33},"Fusion","Fusion at treated levels as measured by x-rays and CT scan.","12 month post surgery (≥10 months post surgery)",[35,39,43,46],{"measure":36,"description":37,"timeFrame":38},"Serious Adverse Events","Incidence of serious adverse events (SAE).","Surgery through study completion",{"measure":40,"description":41,"timeFrame":42},"Change in Pain","Pain improvement as measured by Visual Analog Scale (VAS), 0-100mm. Higher score indicates increased pain.","Baseline and 12 months post surgery",{"measure":44,"description":45,"timeFrame":42},"Change in Disability","Disability improvement as measured by Oswestry Disability Index (ODI), 0-100%. High score indicates increase disability",{"measure":47,"description":48,"timeFrame":42},"Change in Quality of Life","Improvement in qualify of life as measured by 12-item Short Form Health Survey (SF-12), 0-100. High score indicates increase quality of life.","ALL","18 Years",false,{"inclusion":53,"exclusion":59,"raw_text":67},[54,55,56,57,58],"Skeletally mature and age ≥ 18 years of age at the time of surgery","Previously treated with the Karma Fixation System","Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging","Be willing and able to comply with the study protocol requirements","Be willing to sign the study-specific Informed Consent Document",[60,61,62,63,64,65,66],"Previous fusion or total disc replacement at the index level(s)","Active systemic infection at the index level at the time of surgery","Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period","Diagnosis of osteomalacia or Paget's bone disease","Currently enrolled in a competing research study","Currently incarcerated \\\\","Currently pregnant or plans to become pregnant","Inclusion Criteria:\n\n* Skeletally mature and age ≥ 18 years of age at the time of surgery\n* Previously treated with the Karma Fixation System\n* Has at least 12-months post-surgery imaging obtained including a minimum 2 view x-rays (lateral flexion and lateral extension) and CT scan, or willing to return to obtain imaging\n* Be willing and able to comply with the study protocol requirements\n* Be willing to sign the study-specific Informed Consent Document\n\nExclusion Criteria:\n\n* Previous fusion or total disc replacement at the index level(s)\n* Active systemic infection at the index level at the time of surgery\n* Current active or suspected malignancy, or a cancer diagnosis that was ongoing during the patient's treatment and healing period\n* Diagnosis of osteomalacia or Paget's bone disease\n* Currently enrolled in a competing research study\n* Currently incarcerated \\\\\n* Currently pregnant or plans to become pregnant",[69,70],"ADULT","OLDER_ADULT",[72,81,89,97],{"facility":73,"city":74,"state":75,"zip":76,"country":77,"geoPoint":78},"Sonoran Spine","Gilbert","Arizona","85297","United States",{"lat":79,"lon":80},33.35283,-111.78903,{"facility":82,"city":83,"state":84,"zip":85,"country":77,"geoPoint":86},"Ascension St. Vincent's","Jacksonville","Florida","32259",{"lat":87,"lon":88},30.33218,-81.65565,{"facility":90,"city":91,"state":92,"zip":93,"country":77,"geoPoint":94},"The Spine Institute of Louisiana","Shreveport","Louisiana","71101",{"lat":95,"lon":96},32.52515,-93.75018,{"facility":98,"city":99,"state":100,"zip":101,"country":77,"geoPoint":102},"Neuroscience Specialist","Oklahoma City","Oklahoma","73134",{"lat":103,"lon":104},35.46756,-97.51643,[],[],[],[],{"nct_id":4,"conditions":110,"biomarkers":111},[21],[],{"nct_id":4,"found":51,"summary":15,"prompt_version":15}]