[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-disc-prolapse-with-radiculopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-disc-prolapse-with-radiculopathy":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":46,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":5},"100410368","cervical-arthroplasty-cost-effectiveness-study-caces-100410368",false,"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.","ALL","18 Years",{"count":20,"type":21},198,"ESTIMATED","INTERVENTIONAL",[24],"NA","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.",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Radiculopathy, Cervical","Myelopathy Cervical","Myelopathy, Compressive","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",[47,48,49,50,51,52,53,54,55,56,57,58,59,60],"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","RECRUITING","2024-01-24",{"date":64,"type":65},"2024-01-25","ACTUAL",{"date":67,"type":65},"2022-01-17",{"date":69,"type":21},"2028-06-01",{"name":71,"class":72},"Valérie Schuermans","OTHER"]