[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-fusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-fusion":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,39,60,117],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100635768","post-market-observational-clinical-study-with-the-ce-marked-implantable-class-iib-medical-device-itc-cervical-100635768",false,"NCT07556978","Post-market Observational Clinical Study With the CE-marked Implantable Class IIb Medical Device \"ITC CERVICAL\"","Inclusion Criteria:\n\n* The participant must be able to understand the nature, objectives, risks, and benefits of the study and provide free and informed consent, in accordance with current regulations.\n* Patients undergoing primary ACDF (Anterior Cervical Discectomy and Fusion) at two or three (contiguous) levels between C2 and C7\n* Diagnosis of symptomatic degenerative disc disease, including: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, spondylosis, osteophyte complexes, and foraminal stenosis\n* Availability and reliability of the neurological examination and pre- and post-operative clinical and radiological data and medical history\n* Adults (\\>18 years) treated between 2020 and 2024\n\nExclusion Criteria:\n\n* Patients undergoing primary ACDF on a single level between C2 and C7\n* History of previous surgeries in the anatomical area of interest","ALL","18 Years","84 Years",{"count":19,"type":20},33,"ESTIMATED","OBSERVATIONAL","The goal of this observational post-market study is to evaluate the clinical performance and safety of the ITC CERVICAL device, a CE-marked implantable cervical interbody fusion cage, in adult patients undergoing anterior cervical discectomy and fusion (ACDF) for symptomatic cervical degenerative disc disease.\n\nThe main questions it aims to answer are:\n\n1. Does the ITC CERVICAL device improve neck disability and pain after surgery?\n2. Does the device demonstrate adequate radiological performance in terms of cervical alignment, implant stability, and fusion-related outcomes?\n3. Is the device safe when used according to its intended purpose? Researchers will review retrospective clinical and radiological data from patients previously treated with the ITC CERVICAL device between 2020 and 2024. The outcomes assessed will include neck disability, pain intensity, neurological function, general health status, cervical lordosis, implant subsidence or migration, need for revision surgery, and the occurrence of adverse events.\n\nParticipants included in the study are adult patients who previously underwent two- or three-level ACDF surgery with implantation of the ITC CERVICAL device as part of routine clinical care. Clinical data collected before surgery, within 5 days after surgery, and at 3 months follow-up will be analyzed to assess the device's clinical benefits and safety profile.",[24,25],"Cervical Disc Degenerative Disorder","Cervical Fusion","NOT_YET_RECRUITING","2026-04-22",{"date":29,"type":30},"2026-04-29","ACTUAL",{"date":32,"type":20},"2026-05-01",{"date":34,"type":20},"2026-08",{"name":36,"class":37},"MT Ortho s.r.l.","INDUSTRY",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":47,"conditions":48,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":56,"locationsCount":59},"100365693","clinical-and-radiological-outcomes-of-posterior-cervical-fusion-supplemented-with-interfacet-spacers-100365693","NCT04041583","Clinical and Radiological Outcomes of Posterior Cervical Fusion Supplemented With Interfacet Spacers","Inclusion Criteria:\n\n* ≥ 18 years old\n* Symptomatic multi-level degenerative spondylosis necessitating posterior cervical arthrodesis in the subaxial cervicothoracic spine (between C2-upper thoracic).\n* Surgery performed within the Department of Neurological Surgery at The Ohio State University Wexner Medical Center (OSUWMC)\n\nExclusion Criteria:\n\n* Traumatic injury\n* Co-morbidity requiring medication use that may interfere with bone or soft tissue healing (i.e., high dose oral or parenteral glucocorticoids, immunosuppressive agents, methotrexate) - at discretion of investigator\n* Severe co-morbidities (e.g., heart, respiratory, or renal disease)\n* Recent (\\\u003C3 yrs) or co-incident spinal tumor or infection\n* Concurrent involvement in another investigational drug or device study that could confound study data\n* History of substance abuse (recreational drugs, prescription drugs or alcohol) that could interfere with protocol assessments and\u002For with the subject's ability to complete the protocol required follow-up\n* Subjects who are pregnant or plan to become pregnant in the next 24 months\n* Prisoner",{"count":46,"type":20},45,"This is a prospective study to assess fusion rates and cervical sagittal parameters following posterior cervical arthrodesis procedures supplemented with CIS. Data will be collected from medical records for up to 730 days after surgery. Data to be collected will be demographic, preoperative clinical information, surgical details, and radiographic information. Patients will also undergo a non-standard of care CT scan 2 years after surgery.",[25],"RECRUITING","2025-12-23",{"date":52,"type":30},"2025-12-30",{"date":54,"type":30},"2019-09-01",{"date":34,"type":20},{"name":57,"class":58},"Ohio State University","OTHER",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":68,"targetDuration":4,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":93,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":59},"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":69,"type":20},198,"INTERVENTIONAL",[72],"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.",[75,76,77,78,79,80,81,82,83,84,85,86,87,88,25,89,90,91,92],"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 Disc Disorder With Radiculopathy","Cervical Disc Prolapse With Radiculopathy","Fusion of Spine","Disc Prolapse Cervical",[94,95,96,97,98,99,100,101,102,103,104,105,106,107],"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":110,"type":30},"2024-01-25",{"date":112,"type":30},"2022-01-17",{"date":114,"type":20},"2028-06-01",{"name":116,"class":58},"Valérie Schuermans",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":70,"phases":126,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":59},"100411695","phase-4-trigger-point-injections-in-anterior-cervical-surgery-100411695","NCT04640896","Trigger Point Injections in Anterior Cervical Surgery","Comparison of Trigger Point Injections Versus Traditional Therapies in the Management of Postsurgical Pain in Patients Who Had Anterior Cervical Surgery","Inclusion Criteria:\n\n* Elective anterior cervical surgery\n\nExclusion Criteria:\n\n* Emergency surgery\n* Local anesthetic allergy\n* Long term opioid usage (not including tramadol and codeine)\n* Intra-operative complication (e.g. unstable cervical spine)",{"count":125,"type":20},60,[127],"PHASE4","To achieve appropriate exposure for an anterior neck surgery (for example an Anterior Cervical Discectomy and Fusion or ACDF), patients are positioned supine with their neck extended. Due to being in this position, patients frequently complain of posterior neck stiffness and pain postoperatively in addition to the anterior incisional pain. This posterior cervical pain can be classified as myofascial pain.\n\nCervical myofascial pain is thought to be the result of overuse or trauma to the supporting muscles of the neck and shoulders. Trigger point injections are one of the methods used to treat myofascial pain. The trigger point injection procedure is where a physician (typically an anesthesiologist) performs an exam of the patient neck and upper back and finds areas of point tenderness. The physician will then inject a small amount of numbing medication (such as bupivacaine) into the muscle or tissue in that area.\n\nTrigger point injections have been shown to be superior to botox injections or dry needling, and equivalent to physical therapy. However, these studies were performed on patients with chronic neck pain. There are no studies evaluating the effectiveness of trigger point injections on post anterior cervical surgery patients.\n\nAt our institution, trigger point injections with local anesthetic are used as part of a multimodal pain control regimen for post-anterior cervical surgery patients. Our hypothesis is if the addition of trigger point injections to standard of care multi-modal post-operative pain control will decrease patients' myofascial pain, and thereby decrease the amount of narcotic pain medication used.",[130,131,132,25],"Myofacial Pain","Pain, Neck","Pain, Back","2022-12-07",{"date":135,"type":30},"2022-12-08",{"date":137,"type":30},"2020-11-05",{"date":139,"type":20},"2023-12-31",{"name":141,"class":58},"George Washington University"]