[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelopathy-compressive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelopathy-compressive":26},{"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":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100287594","can-prophylactic-foraminotomy-prevent-c5-palsy-100287594",false,"NCT03023696","Can Prophylactic Foraminotomy Prevent C5 Palsy","A Randomized, Prospective Study Determining the Impact of Prophylactic Bilateral Foraminotomy During Cervical Decompression on C5 Palsy","Inclusion Criteria:\n\n* Cleveland Clinic patients who have been diagnosed with cervical myelopathy, without radiculopathy, and will undergo posterior cervical decompression involving the C4-C5 interspace between 2016 and 2018. This includes patients undergoing cervical laminoplasty and cervical laminectomy and fusion.\n\nExclusion Criteria:\n\n* Any patient younger than 18 years of age will not be included on the basis of skeletal immaturity. Patients with C5 radiculopathy - defined in our study as the existence of preoperative deltoid muscle weakness in grade 3 or less by MMT - will be excluded. Any patients who have undergone previous cervical spine surgery, or who have any spinal malignancy, trauma or infection will be excluded in order to eliminate the confounding effect of multiple surgical interventions.","ALL","18 Years",{"count":19,"type":20},480,"ESTIMATED","INTERVENTIONAL",[23],"NA","C5 palsy (C5P) is a well-known, although rare complication of cervical spine decompression surgery. In severe forms, C5P causes debilitating upper extremity weakness involving the deltoids and\u002For biceps brachii muscles, ultimately diminishing these patients' quality of life. Furthermore, about half of patients with C5P present with sensory deficits and\u002For intractable pain in addition to the muscle weakness.\n\nProphylactic bilateral foraminotomy at the C5 level during cervical decompression surgery has been studied recently with the hope that it will minimize the risk of developing a C5 nerve root palsy postoperatively. Although the current literature provides some support for this claim, there are insufficient data establishing this technique as a proven measure to reduce the incidence of C5P. In the present study, we seek to evaluate the effect of bilateral foraminotomy on postoperative C5P incidence rates.\n\nBilateral foraminotomy has been correlated with a reduced risk of developing C5P following cervical decompression surgery, but an identical foraminotomy procedure has never been applied in a randomized manner to all qualifying patients in a study. Additionally, prophylactic foraminotomy has only been prospectively studied during laminoplasty. In the proposed study, bilateral foraminotomy will be randomized to patients receiving cervical decompression surgery (laminoplasty, laminectomy, fusion). This is a multicenter randomized trial, including the following sites: Cleveland Clinic, Columbia University Medical Center, and University of Southern California Spine Center. Patients undergoing cervical decompression surgery will be consented and enrolled if they meet the inclusion and exclusion criteria. Subsequently, incidence of C5P will be monitored to determine efficacy of prophylactic C5 bilateral foraminotomy during cervical decompression.",[26,27,28],"Myelopathy, Compressive","Radiculopathy, Cervical","C5 Palsy",[28,30],"foraminotomy","RECRUITING","2026-01-20",{"date":34,"type":35},"2026-01-22","ACTUAL",{"date":37,"type":35},"2016-06",{"date":39,"type":20},"2026-12",{"name":41,"class":42},"The Cleveland Clinic","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":74,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":43},"100410368","cervical-arthroplasty-cost-effectiveness-study-caces-100410368","NCT04623593","Cervical Arthroplasty Cost Effectiveness Study (CACES)","Economic Evaluation of Anterior Cervical Discectomy With Arthroplasty Versus Anterior Cervical Discectomy With Fusion in the Surgical Treatment of Cervical Degenerative Disc Disease, a Randomized Controlled Trial","CACES","Inclusion Criteria:\n\n* Indication for anterior cervical decompression surgery.\n* Single- or multilevel CDDD between C3 and C7.\n* Symptoms of myelopathy, radiculopathy, or myeloradiculopathy.\n* In case of pure radiculopathy: refractory to at least 6 weeks of conservative therapy.\n* In case of myelopathy: symptomatic myelopathy.\n* Patients ≥ 18 years of age.\n\nExclusion criteria\n\n* Indication for (additional) posterior surgical approach.\n* Indication for additional stabilization of the pathological segment by a plate.\n* Previous ventral surgery of the cervical spine.\n* Traumatic origin of the compression.\n* Previous radiotherapy of the cervical spine.\n* Metabolic bone disease.\n* Inflammatory spinal disease: e.g., Bechterew's disease, Forestier's disease.\n* Infection of the cervical spine.",{"count":53,"type":20},198,[23],"To date, no consensus exists on which anterior surgical technique is more cost-effective to treat cervical degenerative disc disease (CDDD). The most commonly used surgical treatment for patients with single- or multilevel symptomatic CDDD is anterior cervical discectomy with fusion (ACDF). However, new complaints of radiculopathy and\u002For myelopathy commonly develop at adjacent levels, also known as clinical adjacent segment pathology (CASP). It remains unknown to what extent kinematics, surgery-induced fusion and natural history of disease play a role in its development. Anterior cervical discectomy with arthroplasty (ACDA) is thought to reduce the incidence of CASP by preserving motion in the operated segment. ACDA is often discouraged as the implant costs are higher whilst the clinical outcomes are similar to ACDF. However, preventing CASP might be a reason for ACDA to be a more cost-effective technique in the long-term.\n\nIn this randomized controlled trial patients will be randomized to receive ACDF or ACDA in a 1:1 ratio. Adult patients with single- or multi-level CDDD and symptoms of radiculopathy and\u002For myelopathy will be included. The primary outcome is cost-effectiveness and cost-utility of both techniques from a societal perspective. Secondary objectives are the differences in clinical and radiological outcomes between the two techniques, as well as the qualitative process surrounding anterior decompression surgery. All outcomes will be measured at baseline and every 6 months till 4 years postoperatively.\n\nHigh quality evidence regarding the cost-effectiveness of both ACDA and ACDF is lacking, to date no prospective trials from a societal perspective exist. Considering the ageing of the population and the rising healthcare costs, the need for a solid clinical cost-effectiveness trial addressing this question is high.",[27,57,26,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73],"Myelopathy Cervical","Radiculopathy, Cervical Region","Radiculopathy; in Spondylosis","Radiculopathy; in Intervertebral Disc Disorder","Myelopathy Neurological","Myelopathy Due to Spondylosis","Cervical Disc Disease","Cervical Disc Herniation","Cervical Disc Degeneration","Cervical Disc Disorder With Myelopathy","Cervical Disc Prolapse With Myelopathy","Cervical Spondylosis","Cervical Fusion","Cervical Disc Disorder With Radiculopathy","Cervical Disc Prolapse With Radiculopathy","Fusion of Spine","Disc Prolapse Cervical",[75,76,77,78,79,80,81,82,83,84,85,86,87,88],"Cost-effectivity","Economic evaluation","Health Utility","Randomised controlled trial","RCT","ACDA","ACDF","Anterior cervical discectomy and fusion","Anterior cervical discectomy with arthroplasty","Degenerative cervical myelopathy","Degenerative cervical radiculopathy","ASD","Adjacent Segment Disease","Adjacent Level Disease","2024-01-24",{"date":91,"type":35},"2024-01-25",{"date":93,"type":35},"2022-01-17",{"date":95,"type":20},"2028-06-01",{"name":97,"class":42},"Valérie Schuermans"]