[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disc-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disc-disease":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100543195","determining-postoperative-recovery-and-the-impact-of-adverse-events-in-neurosurgery-based-on-self-reported-app-based-longitudinal-assessment-100543195",false,"NCT06352710","Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment","Determining Postoperative Recovery and the Impact of Adverse Events in Neurosurgery Based on Self-reported, App-based Longitudinal Assessment - a Collaborative Observational Research Project","Inclusion Criteria:\n\n* Age ≥ 18 years\n* The patient must be able to consent\n* The patient is willing to provide data upon one year after surgery\n* The patient possesses and is capable of using a smartphone (Android or iOS operative systems)\n* The patient has the necessary language and cognitive skills to use the smartphone app\n* The patient is scheduled for one of the defined operations (see above for both spinal and cranial) and in a stable, non-life-threatening situation (admitted to the regular ward or intermediate care unit (IMC))\n* Baseline preoperative SWI and QoL assessment is possible (minimum requirement is one assessment, the latest the day before surgery)\n\nExclusion Criteria:\n\n* Pregnancy\n* Foreseeable difficulties using the smartphone or smartphone app\n* The presence of a condition that hinders the baseline preoperative assessment\n* Health conditions that render inclusion unsafe (e.g., untreated ruptured intracranial aneurysm or congestive heart failure; in general, all patients admitted to the intensive care unit (ICU))","ALL","18 Years",{"count":19,"type":20},400,"ESTIMATED","OBSERVATIONAL","Analyzing the impact of surgery and adverse events (AEs) on patients' well-being is of paramount importance as it provides essential information for benefit-risk assessment. Current methods in outcome research are static, resource-intensive and subject to missing-data issues. Moreover, AEs are inconsistently reported using various grading systems that usually do not account for patients' subjective well-being. These are severe drawbacks for outcome research as it hinders monitoring, comparison, and improvement of treatment quality.\n\nThe increasing use of smartphones offers unprecedented opportunities for data collection. The investigators developed a free smartphone application to assess fluctuations of patients' well-being as a result of surgical treatment and possible AEs. The application is installed on each patient's smartphone and collects standardized data at defined timepoints before and after surgery (well-being, AE description and severity).\n\nBy acquiring longitudinal patient-reported outcome before and after neurosurgical interventions, the investigators aim to determine the regular postoperative course for specific surgical procedures, as well as any deviation thereof, depending on the occurrence and severity of AEs. The investigators will evaluate the validity of existing AE classifications and, if necessary, propose a new patient-centered scheme. The investigators hope that this will result in an increase in standardized reporting of patient outcome, and ultimately allow for evidence-based patient information and decision-making.",[24,25,26,27],"Disc Disease","Instabilities Lumbar","Brain Tumor","Aneurysm",[29,30,31,32,33,34,35,36],"Outcome","PROMs","App","Neurosurgery","Adverse event","Complication","Quality of life","TDN","RECRUITING","2026-03-17",{"date":40,"type":41},"2026-03-19","ACTUAL",{"date":43,"type":41},"2023-06-12",{"date":45,"type":20},"2027-12-31",{"name":47,"class":48},"Cantonal Hospital of St. Gallen","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100544359","phase-4-efficacy-and-safety-of-preemptive-intravenous-dexamethasone-in-mis-tlif-100544359","NCT06367855","Efficacy and Safety of Preemptive Intravenous Dexamethasone in MIS-TLIF","MIS-TLIF","Inclusion Criteria:\n\n* Age range: 50-80 years old.\n* Undergoing MIS TLIF surgery at 1-2 spinal levels.\n\nExclusion Criteria:\n\n* Previously undergone spine surgery.\n* HbA1C greater than or equal to 7.5 mg%\n* Allergic to all types of experimental medication.\n* History of using systemic steroids.",true,"50 Years","80 Years",{"count":61,"type":20},60,"INTERVENTIONAL",[64],"PHASE4","Researchers are considering Dexamethasone as preemptive medication before minimally invasive spine fusion surgery to minimize postoperative back pain with minimal side effects, aiming to enhance the effectiveness of surgery and improve patient outcomes.",[67,68,24,69,70],"Spinal Stenosis Lumbar","Disc Degeneration","Fusion of Spine","Surgery","2025-08-31",{"date":73,"type":41},"2025-09-08",{"date":75,"type":41},"2024-05-01",{"date":77,"type":20},"2025-12-31",{"name":79,"class":48},"Potsawat Surabotsopon",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":57,"sex":16,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":4,"studyType":62,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100513888","pilot-study-of-zetafuse-bone-graft-for-the-treatment-of-cervical-degenerative-disc-disease-100513888","NCT05971329","Pilot Study of ZetaFuse™ Bone Graft for the Treatment of Cervical Degenerative Disc Disease","Inclusion Criteria:\n\n1. Age 22 to 75 years (inclusive) at the time of enrollment.\n2. Diagnosis of radiculopathy and\u002For myelopathy of the cervical spine, with pain, paresthesias or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:\n\n   * Neck and\u002For arm pain (at least 3 on the 0 - 10 numeric rating scale for pain.\n   * Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.\n   * Abnormal sensation including hyperesthesia or hypoesthesia. and\u002For\n   * Abnormal reflexes.\n3. Symptomatic at one or two contiguous levels from C3 to C7.\n4. Radiographically determined pathology at the level to be treated correlating to primary symptoms including at least one of the following:\n\n   * Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.\n   * Degenerative spondylosis on CT or MRI.\n   * Disc herniation on CT or MRI.\n5. Neck Disability Index Score ≥ 30\u002F100.\n6. Unresponsive to non-operative treatment (e.g., rest, heat, physical therapy, chiropractor, massage, pain medication) for approximately six weeks from the symptom onset; or has the presence of progressive symptoms or signs of nerve root\u002Fspinal cord compression in the face of continued non-operative management.\n7. No previous surgical intervention at the involved levels or any subsequent, planned\u002Fstaged surgical procedure at the involved or adjacent levels.\n8. Appropriate for treatment using an anterior surgical approach.\n9. Skeletally mature at the time of the surgery.\n10. Medically cleared for surgery.\n11. If a female of child-bearing potential, subject is non-pregnant, nonnursing, and agrees not to become pregnant during the study period.\n12. Willing and able to comply with the study plan.\n13. Signed written Patient Informed Consent Form.\n14. Willing to discontinue use of non-steroidal anti-inflammatory drugs (NSAIDs) from one week before the surgery to 3 months after the surgery.\n\nExclusion Criteria:\n\n1. A cervical spinal condition other than symptomatic cervical degenerative disc disease requiring surgical treatment at the involved levels.\n2. Documented or diagnosed cervical instability relative to adjacent segments at either level, defined by dynamic (flexion\u002Fextension) radiographs showing sagittal plane translation \\>3.5 mm or sagittal plane angulation \\> 20°.\n3. More than two cervical levels requiring surgical treatment.\n4. An immobile or spontaneously fused level adjacent to the levels to be treated.\n5. Severe pathology of the facet joints of the involved vertebral bodies.\n6. Previous surgical intervention at either one or both of the involved levels or at adjacent levels.\n7. History of trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.\n8. Previously diagnosed with osteomalacia;\n9. Any of the following that may be associated with an increased risk osteoporosis (if \"Yes\" to any of the below risk factors, a DEXA Scan is required to determine eligibility). If the level of bone mineral density (BMD) on DEXA scan is a T score of -2.5 or worse (i.e., -2.6, - 2.7, etc.) the subject is ineligible for the study.\n\n   * Postmenopausal non-Black female over 60 years of age who weighs less than 140 pounds.\n   * Postmenopausal female who has sustained a non-traumatic hip, spine, or wrist fracture.\n   * Male over the age of 60 who has sustained a non-traumatic hip or spine fracture.\n   * Taking bisphosphonate medication for the treatment of osteoporosis.\n   * Chronic use of high dose steroids.\n10. Reported active malignancy that included a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there had been no clinical signs or symptoms of the malignancy for at least five years.\n11. Overt or active systemic infection, or infection at the operative site.\n12. Insulin dependent diabetes.\n13. A tobacco user who does not agree to suspend smoking prior to surgery.\n14. Chronic or acute renal failure or prior history of renal disease.\n15. Mentally incompetent (If questionable, obtain psychiatric consult).\n16. A prisoner.\n17. An alcohol and\u002For drug abuser currently or recently undergoing treatment for alcohol and\u002For drug abuse.\n18. Involved with current or pending litigation regarding a spinal condition.\n19. Received drugs that may interfere with bone metabolism within two weeks prior to the planned date of spinal surgery (e.g., steroids or methotrexate) excluding routine perioperative anti-inflammatory drugs.\n20. A history of an endocrine or metabolic disorder known to affect osteogenesis (e.g., Paget's Disease, renal osteodystrophy, Ehlers- Danlos Syndrome, or osteogenesis imperfecta).\n21. A condition that requires post-operative medications that interfere with the stability of the implant, such as steroids. (This does not include low dose aspirin for prophylactic anticoagulation and routine perioperative anti-inflammatory drugs).\n22. Received treatment with an investigational therapy within 28 days prior to implantation surgery or such treatment is planned during the 16 weeks following implantation with the ZetaFuse™ Bone Graft device.","22 Years","75 Years",{"count":89,"type":20},10,[91],"NA","The goal of this pilot clinical trial is to test the safety and preliminary performance of the ZetaFuse Bone Graft in patient requiring fusion of the C3-C7 vertebral bones due to pain or loss of neurological function.\n\nParticipants will be treated with ZetaFuse during surgical intervention to reduce pain and the loss of neurological function.",[94,95,96,24,68],"Radiculopathy, Cervical","Myelopathy Cervical","Neurological Abnormality","2025-04-18",{"date":99,"type":41},"2025-04-24",{"date":101,"type":20},"2026-09",{"date":103,"type":20},"2027-09",{"name":105,"class":106},"Zetagen Therapeutics, Inc","INDUSTRY",2]