[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cervical-disc-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cervical-disc-disease":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,67],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100615042","a-multi-center-prospective-historically-controlled-clinical-trial-comparing-the-safety-and-effectiveness-of-triadyme-c-to-a-total-disc-replacement-control-cohort-in-the-treatment-of-symptomatic-cervical-disc-disease-scdd-at-a-single-level-100615042",false,"NCT07287449","A Multi-Center, Prospective Historically Controlled Clinical Trial Comparing the Safety and Effectiveness of Triadyme-C to a Total Disc Replacement Control Cohort in the Treatment of Symptomatic Cervical Disc Disease (SCDD) at a Single Level","Inclusion Criteria:\n\n1. Male or female subject, age ≥21.\n2. Diagnosis of radiculopathy or myeloradiculopathy of the cervical spine, with pain, paresthesia or paralysis in a specific nerve root distribution C3 through C7, including at least one of the following:\n\n   1. Neck and\u002For arm pain (at least 30 mm on the 100 mm visual analogue scale \\[VAS\\] scale).\n   2. Decreased muscle strength of at least one level on the clinical evaluation 0 to 5 scale.\n   3. Abnormal sensation including hyperesthesia or hypoesthesia; and\u002For\n   4. Abnormal reflexes.\n3. Symptomatic at a single level 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   1. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc.\n   2. Degenerative spondylosis on CT or MRI.\n   3. Disc herniation on CT or MRI.\n5. Neck Disability Index (NDI) Score ≥ 30 (out of 100).\n6. Unresponsive to non-operative, conservative treatment (e.g., rest, heat, electrotherapy, physical therapy, chiropractic care and\u002For analgesics) for:\n\n   1. At least six weeks from radiculopathy or myeloradiculopathy symptom onset; or\n   2. Have the presence of progressive symptoms or signs of nerve root\u002Fspinal cord compression despite continued non-operative conservative treatment.\n7. Appropriate for treatment using an anterior surgical approach.\n8. Reported to be medically cleared for surgery.\n9. Reported to be physically and mentally able and willing to comply with the Protocol, including the ability to read and complete required forms and willing and able to adhere to the scheduled follow-up visits and requirements of the Protocol.\n10. Written informed consent provided by subject.\n\nExclusion Criteria:\n\n1. Have an active systemic infection or infection at the operative site.\n2. Have a history of or anticipated treatment for active systemic infection, including HIV or Hepatitis C.\n3. Have more than one immobile vertebral level between C1 to C7 from any cause including but not limited to congenital abnormalities and osteoarthritic \"spontaneous\" fusions.\n4. Have previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury.\n5. Prior attempted or completed cervical spine surgery at any cervical level, except (1) a minimally invasive decompression that did not de-stabilize the segment upon flexion\u002Fextension or (2) a successful single-level anterior cervical fusion at non-index level (greater than 6 months prior to scheduled surgical treatment).\n6. Have axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention.\n7. Have disc height less than 3 mm as measured from the center of the disc in a neutral position.\n8. Evidence of symptomatic moderate to severe facet joint degeneration or disease where the investigator feels this is a major contributor to the subject's pain as diagnosed by injection and imaging.\n9. Have osteoporosis or is an increased risk of osteoporosis\u002Fosteopenia defined as a T-score less than -1.5 (i.e., -1.6, -1.7, etc.).\n\n   1. The SCORE\u002FMORES will be used to screen if a dual energy X-ray absorptiometry (DEXA) scan is required. If SCORE\u002FMORES value ≥ 6, then a DEXA is required.\n   2. An existing DEXA is allowed if completed within 12 months of subject surgery.\n10. Have diabetes mellitus requiring daily insulin management.\n11. Have severe myelopathy to the extent that the patient is wheelchair bound.\n12. Have Paget's disease, osteomalacia or any other metabolic bone disease other than osteoporosis, which is addressed above (i.e., Exclusion #9).\n13. Have active malignancy that includes a history of any invasive malignancy (except non-melanoma skin cancer) unless the subject had been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least five years.\n14. Have tumor as source of symptoms.\n15. Have Symptomatic Cervical Degenerative Disc Disease (SDDD) or significant cervical spondylosis at two or more levels.\n16. Have spondylolysis.\n17. Have arachnoiditis.\n18. Have marked cervical instability on resting (neutral) lateral or flexion-extension radiographs demonstrated by:\n\n    1. Translation ≥ 3.5 mm, and\u002For\n    2. Greater than 11° angular difference to that of either adjacent level.\n19. Have a known allergy to implant materials (titanium, Ti-6Al-4V alloy, TiC, or SnCoCrMo alloy).",true,"ALL","21 Years",{"count":19,"type":20},164,"ESTIMATED","INTERVENTIONAL",[23],"NA","A multicenter, prospective, historically controlled study to evaluate the safety and effectiveness of the Triadyme-C device in comparison to other approved TDRs in the treatment of symptomatic cervical disc disease (SCDD) in subjects who are symptomatic at only a single level from C3 to C7 that are unresponsive to conservative management.",[26],"Cervical Disc Disease","NOT_YET_RECRUITING","2025-12-12",{"date":30,"type":31},"2025-12-17","ACTUAL",{"date":33,"type":20},"2026-01-05",{"date":35,"type":20},"2029-07-31",{"name":37,"class":38},"Dymicron","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":66},"100562320","predictors-of-axial-pain-improvement-after-anterior-cervical-discectomy-and-fusion-100562320","NCT06601634","Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion","Predictors of Axial Pain Improvement After Anterior Cervical Discectomy and Fusion - Prospective, Observational Study","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Patients who are qualified for one- or two-level ACDF for the treatment of degenerative cervical pathology\n\nExclusion Criteria:\n\n* Previous cervical spine surgery\n* Previous cervical spine trauma\n* Other diseases causing neck pain include rheumatoid arthritis, lupus, polymyalgia rheumatica, myositis, seronegative inflammatory diseases, and fibromyalgia\n* Drug abuse\n* Myelopathy\n* Spinal infection\n* VAS neck pain score less than 3 (Inability to achieve an MCID which is calculated as 2.5 for the VAS scale)","18 Years","65 Years",{"count":49,"type":20},60,"OBSERVATIONAL","Neck pain is a common, multifactorial condition. In the case of degenerative cervical spinal disease, it can result from changes in the intervertebral discs, muscles, intervertebral joints, or sagittal imbalance. Anterior cervical discectomy and fusion (ACDF) is a currently widely accepted procedure for treating cervical degenerative spine disease, with a high patient satisfaction rate. In the current state of knowledge, it is not used for treating axial neck pain, but rather in cases of discopathy causing spinal myelopathy or cervical radiculopathy, in which neck pain often coexists or predominates. The current literature provides ample evidence of the significant effect of ACDF in improving axial neck pain in the conditions mentioned previously. However, little information exists on which patients achieve improvement. The aim of this prospective study is to analyze the outcomes of ACDF in patients with neck pain and to identify predictors of reduction in axial neck pain after ACDF.",[53,54,26],"Neck Pain","Cervical Spondylosis","RECRUITING","2025-03-25",{"date":58,"type":31},"2025-03-26",{"date":60,"type":31},"2024-11-17",{"date":62,"type":20},"2027-12",{"name":64,"class":65},"Medical University of Warsaw","OTHER",2,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":97,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"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":76,"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.",[80,81,82,83,84,85,86,87,26,88,89,90,91,54,92,93,94,95,96],"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 Herniation","Cervical Disc Degeneration","Cervical Disc Disorder With Myelopathy","Cervical Disc Prolapse With Myelopathy","Cervical Fusion","Cervical Disc Disorder With Radiculopathy","Cervical Disc Prolapse With Radiculopathy","Fusion of Spine","Disc Prolapse Cervical",[98,99,100,101,102,103,104,105,106,107,108,109,110,111],"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":114,"type":31},"2024-01-25",{"date":116,"type":31},"2022-01-17",{"date":118,"type":20},"2028-06-01",{"name":120,"class":65},"Valérie Schuermans",1]