[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"radiculopathy-cervical\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:radiculopathy-cervical":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,73,93],{"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":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"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.",true,"22 Years","75 Years",{"count":54,"type":20},10,[23],"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.",[27,58,59,60,61],"Myelopathy Cervical","Neurological Abnormality","Disc Disease","Disc Degeneration","2025-04-18",{"date":64,"type":35},"2025-04-24",{"date":66,"type":20},"2026-09",{"date":68,"type":20},"2027-09",{"name":70,"class":71},"Zetagen Therapeutics, Inc","INDUSTRY",2,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":50,"sex":16,"minAge":17,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":21,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":89,"leadSponsor":91,"locationsCount":43},"100550954","effect-of-cervical-exercise-combined-with-nerve-mobilization-on-cervical-spondylotic-radiculopathy-100550954","NCT06453798","Effect of Cervical Exercise Combined With Nerve Mobilization on Cervical Spondylotic Radiculopathy","Inclusion Criteria:\n\n1. Meet the diagnostic criteria of CSR and have no other complications;\n2. Age 18-65 years old, gender unlimited;\n3. No other treatment for cervical spondylosis in the last 1 month;\n4. No previous surgical treatment for cervical spondylosis;\n5. Good compliance;\n6. Good mental state, no history of mental illness;\n7. Informed consent, and sign the informed consent.\n\nExclusion Criteria:\n\n1. does not meet the diagnostic criteria;\n2. Women during pregnancy;\n3. severe stenosis of the foramen;\n4. osteoporosis combined with spinal cord tumor, osteomyelitis;\n5. infectious diseases, skin defects, allergies;\n6. have serious heart, lung and other important organ dysfunction;\n7. unable to cooperate.","65 Years",{"count":81,"type":20},60,[23],"The objective of this clinical trial was to investigate the effects of cervical spine exercises combined with nerve mobilization in patients with radiculopathy.\n\nThe main questions it aims to answer are:\n\n1. Whether cervical spine operation combined with nerve mobilization is effective for cervical radiculopathy.\n2. Is there any difference between cervical spine operation combined with nerve mobilization and single method? The participants were patients with cervical radiculopathy and were divided into three groups in this study.\n\n1\\. Experimental group: received cervical spine operation combined with nerve mobilization 2. Control group 1: cervical spine exercises were performed 3. Control group 2: received neuromobilization",[27],"2024-07-05",{"date":87,"type":35},"2024-07-08",{"date":85,"type":35},{"date":90,"type":20},"2024-12-31",{"name":92,"class":42},"Quanzheng Chen",{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":104,"conditions":105,"keywords":122,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"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":102,"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.",[27,58,26,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121],"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",[123,124,125,126,127,128,129,130,131,132,133,134,135,136],"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":139,"type":35},"2024-01-25",{"date":141,"type":35},"2022-01-17",{"date":143,"type":20},"2028-06-01",{"name":145,"class":42},"Valérie Schuermans"]