[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07734467":3,"trial-entities:NCT07734467":83,"trial-summary:NCT07734467":86},{"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":22,"study_type":23,"primary_purpose":14,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":54,"locations":58,"central_contacts":77,"overall_officials":79,"references":81,"see_also_links":82},"NCT07734467","STUDY00005908","Immune Response to PSF in Idiopathic vs Neuromuscular Scoliosis","Comparison of Immune Response Following Posterior Spinal Fusion in Patients With Idiopathic vs. Neuromuscular Scoliosis","NOT_YET_RECRUITING","2029-12","2026-07","2026-07-29","2026-10","Ambrish Patel","OTHER",false,"The objective of this study is to evaluate the immune response to posterior spinal fusion (PSF) in patients with neuromuscular scoliosis, comparing patients with idiopathic scoliosis who undergo the same procedure. This will be accomplished using serum biomarkers of immune response. Anecdotally, it appears that patients with neuromuscular scoliosis have more fluid resuscitation needs compared to patients with idiopathic scoliosis. The proposed hypothesis of this observation is that patients with neuromuscular scoliosis have a more profound immune response compared to patients with idiopathic scoliosis, which leads to a more robust systematic inflammatory response syndrome.","The primary endpoint is to evaluate serum immune profile assays obtained pre-operatively and post-operatively comparing patients with neuromuscular scoliosis to those with idiopathic scoliosis undergoing posterior spinal fusion. This will be done by obtaining a blood sample prior to incision in the operating room and one when the patient is in the PACU, prior to leaving. In the event that the patient is directly admitted to the pediatric intensive care unit (PICU), a sample will be obtained there. As part of standard of care, patients undergoing PSF have a peripheral arterial lane placed for intra-operative monitoring and blood draws. Samples drawn will determine serum immunophenotyping using cytokine profiles for the immune response testing. No investigational medications\u002Fdevices or deviations from standard of care are required for study participation.\n\nThis will be an observational study in patients undergoing posterior spinal fusion. The anesthetic and surgical management of the patient will follow current standard of care, and the study design will not impact the current care of the patient. We will enroll 10 patients with idiopathic scoliosis, and 10 patients with neuromuscular scoliosis. The primary endpoint of the study is to evaluate the immune response to posterior spinal fusion in patients with neuromuscular scoliosis, comparing them to patients with idiopathic scoliosis. Serum samples will be taken to evaluate serum immune profile assays. A secondary objective will be to compare and contrast the effect of transfusions (autologous and allogenic) on the immune response. We will collect information from the EMR including sociodemographic data, clinical data, and intraoperative data.\n\nAs part of standard of care, patients undergoing posterior spinal fusion have a peripheral arterial line placed for intraoperative monitoring and blood draws. Prior to incision, a blood sample will be obtained that will determine immunophenotyping using cytokine profiles. We will follow NCH guidelines for total blood draw volumes for pediatric patients.\n\nAfter the operation is complete and the patient is extubated after emergence from general anesthesia, the patient will move to the PACU. Prior to the patient leaving the PACU, the second sample would be obtained - serum immunophenotyping defined as the post-operative sample. In the event the patient is directly admitted to the PICU, a sample would be obtained in the PICU. In all cases, the sample will be collected by nurses or physicians and given to the research staff to complete the immune response testing.",[19,20,21],"Posterior Spinal Fusion","Idiopathic Scoliosis","Neuromuscular Scoliosis",[],"INTERVENTIONAL",[25],"NA",{"count":27,"type":28},20,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DIAGNOSTIC_TEST","Serum blood samples for serum biomarkers of immune response","Preoperative and postoperative blood samples using biomarkers to evaluate immune response.",[35,36],"Idiopathic scoliosis","Neuromuscular scoliosis",[38],{"measure":39,"description":40,"timeFrame":41},"Immune response to posterior spinal fusion in patients with neuromuscular scoliosis compared to patients with idiopathic scoliosis","Blood samples to determine serum immunophenotyping using cytokine profiles for immune response testing.","From enrollment to approximately one hour after surgery completion.",[],"ALL","0 Years","99 Years",{"inclusion":47,"exclusion":50,"raw_text":53},[48,49],"Any patient undergoing a posterior spinal fusion, regardless of age (birth to adult)","any patient with a diagnosis of idiopathic or neuromuscular scoliosis",[51,52],"Patient taking immunomodulators (monoclonal antibodies, chemotherapeutic agents)","chronic steroid use","Inclusion Criteria:\n\n* Any patient undergoing a posterior spinal fusion, regardless of age (birth to adult)\n* any patient with a diagnosis of idiopathic or neuromuscular scoliosis\n\nExclusion Criteria:\n\n* Patient taking immunomodulators (monoclonal antibodies, chemotherapeutic agents)\n* chronic steroid use",[55,56,57],"CHILD","ADULT","OLDER_ADULT",[59],{"facility":60,"city":61,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":74},"Nationwide Children's Hospital","Columbus","Ohio","43205","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Catherine Roth","CONTACT","614-722-2997","catherine.roth@nationwidechildrens.org",{"name":72,"role":73},"Ambrish Patel, MD","PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},39.96118,-82.99879,[78],{"name":67,"role":68,"phone":69,"email":70},[80],{"name":72,"affiliation":60,"role":73},[],[],{"nct_id":4,"conditions":84,"biomarkers":85},[35,36],[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an observational study involving 20 participants, 10 with idiopathic scoliosis and 10 with neuromuscular scoliosis. It is not a randomized study and does not involve new medications or devices.","completed","Immune Response to Posterior Spinal Fusion in Scoliosis","This study is looking at how your body's immune system reacts to posterior spinal fusion (PSF) surgery for scoliosis. Researchers want to see if patients with neuromuscular scoliosis have a stronger immune response compared to those with idiopathic scoliosis after this surgery. They will do this by taking blood samples before and after surgery to measure immune system markers. The study aims to understand if a stronger immune response in neuromuscular scoliosis might explain why these patients sometimes need more fluid during recovery. You can join if you are having PSF for either idiopathic or neuromuscular scoliosis, are between 0 and 99 years old, and are not taking certain immune-affecting medications or chronic steroids. The study status is currently unclear.","Your immune response will be measured from enrollment until approximately one hour after surgery completion.",120,"You would have two blood samples taken: one before surgery and one after surgery (either in the recovery room or intensive care unit). These samples are taken during routine procedures.","Not stated in the trial record.",[],"v2"]