[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lumbar-disc-herniation-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lumbar-disc-herniation-surgery":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100644064","phase-4-return-to-activity-after-surgery-for-lumbar-disc-herniation-100644064",false,"NCT07667348","Return to Activity After Surgery for Lumbar Disc Herniation","Return to Activity After Surgery for Lumbar Disc Herniation: An Exploratory, Post-Market, Prospective, Randomized, Controlled Trial of an Annular Closure Device","Inclusion Criteria:\n\n* Skeletally mature (male or female).\n* Patients with posterior or posterolateral disc herniations at one level between L4 and S1 with radiographic confirmation of neural compression using MRI. \\[Note: Intraoperatively, only patients with an annular defect (post discectomy) between 4mm and 6mm tall and 6mm and 10mm wide shall qualify.\\]\n* Minimum posterior disc height of 5mm at the index level.\n* Radiculopathy (with or without back pain) with a positive Straight Leg Raise (0 - 60 degrees)22 (L45, L5S1)\n* VAS leg pain (one or both legs) of at least 40\u002F100 at baseline\n* Psychosocially, mentally and physically able to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.\n* Implanted with annular closure device.\n\nExclusion Criteria:\n\n* Spondylolisthesis Grade II or higher (25% slip or greater).\n* Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg\u002Fback pain (scar tissue and osteophyte removal is allowed).\n* Subject has been diagnosed with active hepatitis, AIDS, or HIV.\n* Subject has been diagnosed with rheumatoid arthritis or other autoimmune disease.\n* Subject has a known allergy to titanium, polyethylene or polyester materials.\n* Any subject that cannot have a baseline MRI taken.\n* Subject is pregnant or interested in becoming pregnant in the next year.\n* Subject has active tuberculosis or has had tuberculosis in the past three (3) years.\n* Subject has a history of active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he\u002Fshe has been treated with curative intent and there have been no signs or symptoms of the malignancy for at least two (2) years.\n* Subject is immunologically suppressed, received steroids \\>1 month over the past year.\n* Currently taking anticoagulants, other than aspirin, unless the patient can be taken off the anticoagulant for surgery.\n* Subject has a current chemical\u002Falcohol dependency or significant psychosocial disturbance.\n* Subject has a life expectancy of less than three (3) years.\n* Subject is currently involved in active spinal litigation (Workers' compensation patients may be included.\n* Subject is currently involved in another investigational study.\n* Subject is incarcerated.\n* Subject has back or non-radicular leg pain of unknown etiology.\n* Prior surgery at the index lumbar vertebral level.\n* Subject requiring a spine DEXA (i.e., patients with SCORE of ≥ 6) with a T Score less than -2.0 at the index level. For patients with a herniation at L5\u002FS1, the average T score of L1-L4 shall be used.\n* Subject has clinically compromised vertebral bodies in the lumbosacral region due to any traumatic, neoplastic, metabolic, or infectious pathology.\n* Subject has sustained pathologic fractures of the vertebra or multiple fractures of the vertebra or hip.\n* Subject has scoliosis of greater than ten (10) degrees (both angular and rotational).\n* Any metabolic bone disease.\n* Subject has an active infection either systemic or local.\n* Subject has cauda equina syndrome or neurogenic bowel\u002Fbladder dysfunction.\n* Subject has severe arterial insufficiency of the legs or other peripheral vascular disease. (Screening on physical examination for patients with diminution or absence of dorsalis pedis or posterior tibialis pulses. If diminished or absent by palpation, then an arterial ultrasound is required with vascular plethysmography. If the absolute arterial pressure is below 50mm of Hg at the calf or ankle level, then the patient is to be excluded.)\n* Subject has significant peripheral neuropathy, patient defined as a patient with Type I or Type II diabetes or similar systemic metabolic condition causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities.\n* Subject has insulin-dependent diabetes mellitus.\n* Subject is morbidly obese (defined as a body mass index \\>40 or weighs more than 100 lbs. over ideal body weight).","ALL",{"count":18,"type":19},120,"ESTIMATED","INTERVENTIONAL",[22],"PHASE4","RCT investigating postoperative activity restriction after lumbar discectomy in patients treated with annular closure.",[25,26],"Lumbar Disc Herniation Surgery","Disc Herniation",[28,29,30],"Lumbar discectomy","postoperative instructions","lumbar disc herniation","NOT_YET_RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":19},"2026-06-30",{"date":39,"type":19},"2027-10-31",{"name":41,"class":42},"Intrinsic Therapeutics","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":68,"leadSponsor":70,"locationsCount":43},"100639262","flow-controlled-versus-volume-controlled-ventilation-in-lumbar-disc-herniation-surgery-100639262","NCT07614555","Flow-Controlled Versus Volume-Controlled Ventilation in Lumbar Disc Herniation Surgery","Comparison of Flow-Controlled and Volume-Controlled Ventilation During Lumbar Disc Herniation Surgery: A Prospective Randomized Trial","Inclusion Criteria:\n\n* Age between 18 and 65 years\n* ASA physical status I-III\n* Body Mass Index between 18 and 30 kg\u002Fm²\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years or \\> 65 years\n* Known or previously diagnosed pulmonary disease\n* Patients with severe preoperative pulmonary function impairment (e.g., FEV₁ \\\u003C 50% predicted, severe restrictive or obstructive pathology)\n* Patients with markedly altered lung anatomy or function due to prior major thoracic surgery\n* Patients who were dependent on supplemental oxygen therapy in the preoperative period\n* ASA physical status IV or higher\n* Refusal or inability to provide informed consent","18 Years","65 Years",{"count":54,"type":19},80,[56],"NA","This prospective randomized trial aims to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on intraoperative airway pressures and oxygenation in patients undergoing lumbar disc herniation surgery under general anesthesia.\n\nAdult patients aged 18-65 years, with ASA physical status I-III and a body mass index of 18-30 kg\u002Fm², will be allocated to receive either FCV or VCV during routine intraoperative mechanical ventilation. Ventilatory parameters, including peak airway pressure, plateau pressure, pulmonary compliance, EtCO₂, SpO₂, and arterial blood gas variables, will be recorded at predefined time points after intubation.\n\nThe primary endpoint is the PaO₂ value measured after 20 minutes in the prone position.\n\nBy comparing respiratory mechanics and oxygenation between the two ventilation modes, this study aims to contribute to the optimization of intraoperative ventilatory management in lumbar disc herniation surgery.",[25,59],"Mechanical Ventilation",[61,62,25],"Flow-Controlled Ventilation","Volume-Controlled Ventilation","RECRUITING","2026-05-28",{"date":66,"type":35},"2026-06-01",{"date":64,"type":35},{"date":69,"type":19},"2026-11-26",{"name":71,"class":72},"Ankara Etlik City Hospital","OTHER_GOV"]