[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648404":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":87,"whyStopped":25,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Providence Medical Technology, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Anterior Cervical Discectomy and Fusion (ACDF)","ACTIVE_COMPARATOR","Anterior Cervical Discectomy and Fusion (ACDF), which is a standard of care procedure",[13],"Procedure: Anterior Cervical Discectomy and Fusion",{"label":15,"type":16,"description":17,"interventionNames":18},"Circumferential Cervical Fusion (CCF)","EXPERIMENTAL","Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF)",[19],"Device: Circumferential Cervical Fusion (CCF)",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Circumferential Cervical Fusion (CCF), which is a combination of ACDF and Posterior Cervical Fusion (PCF) performed during the same surgical procedure, irrespective of order. The PCF procedure is performed using CORUS™ Spinal System-X to access and prepare the joint for fusion, followed by placement of PCSS 3D and delivery of an allograft demineralized bone matrix (DBM).",[15],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"PROCEDURE","Anterior Cervical Discectomy and Fusion","ACDF is performed using standard instruments and completed with a titanium interbody implant and anterior semi-constrained plate. The plate is intended to stabilize the treated levels until fusion occurs.",[9],[32],{"name":33,"affiliation":5,"role":34},"Matt Jenkins","STUDY_DIRECTOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","805-450-4965","mjenkins@providencemt.com",{"name":41,"role":37,"phone":42,"phoneExt":25,"email":43},"Stacey Underwood","520-262-3704","sunderwood@providencemt.com",[45],{"facility":46,"status":25,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":25},"The Orthopaedic Institute","Paducah","Kentucky","42001","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-88.60005,37.08339,{"lat":56,"lon":55},{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100648404","evaluation-of-the-safety-and-effectiveness-of-the-corus-posterior-cervical-stabilization-system-3d-pcss-3d-for-the-treatment-of-2-level-cervical-degenerative-disease-100648404",false,"NCT07721493","Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease","An Assessment of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) to Determine Superiority to ANterior Cervical Discectomy and Fusion (ACDF) in the Treatment of 2-Level Cervical Degenerative Disease","SECOND","Inclusion Criteria:\n\n* At least 18 years of age (Skeletally Mature)\n* Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following:\n\n  1. diagnosis of radiculopathy, myelopathy or myeloradiculopathy of the cervical spine, with pain, including at least one of the following: i. Neck and\u002For arm pain, ii. Decreased muscle strength, and iii. Abnormal sensation including hyperesthesia or hypoesthesia; and\u002For Abnormal reflexes.\n  2. radiographically determined pathology at the levels to be treated correlating to primary symptoms including at least one of the following: i. Decreased disc height on radiography, computed tomography (CT), or magnetic resonance imaging (MRI) in comparison to a normal adjacent disc, ii. Degenerative spondylosis on MRI, and iii. Disc herniation on MRI.\n* NDI Score of ≥ 15\u002F50\n* Unresponsive to non-operative, conservative treatment (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.\n* Reported to be medically cleared for surgery\n* 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;\n* Written informed consent provided by subject.\n\nExclusion Criteria:\n\n* Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)\n* Active systemic infection or infection at the operative site\n* History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C\n* Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement\n* A prior spine surgery or pseudoarthrosis at the operative levels\n* Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention\n* Symptomatic DDD or significant cervical spondylosis at more than two levels\n* Diagnosis of Spondylolisthesis, grade \\>2\n* Overt (Segmental) instability measured as a movement on dynamic flex\u002Fextend x-rays \\> 3.5 mm\n* Congenital bony and\u002For spinal cord abnormalities that affect spinal stability\n* Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia\n* Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5\n* Active malignancy or a history of any invasive malignancy (except non-melanoma skin cancer), unless treated with curative intent and without clinical signs or symptoms of the malignancy for at least five years\n* Has an uncontrolled seizure disorder\n* Use of epidural steroids within 14 days prior to surgery\n* A concomitant condition requiring daily, high-dose oral and\u002For inhaled steroids. High dose steroid use is defined as:\n\n  1. daily, chronic use of oral steroids of 5 mg\u002Fday or greater.\n  2. use of short-term (less than 10 days) oral steroids at a daily dose greater than 40 mg within one month of the study procedure.\n* Known allergy to titanium (Ti)\n* Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression\n* Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders)\n* Is pregnant or nursing at time of screening, or with plans to become pregnant throughout the duration of the study.\n* A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and\u002For narcotic addiction) that required treatment\n* Long term use (\\>6 months) of opioids (max. daily amount=120 mg morphine equivalents)\n* A mental illness or belongs to a vulnerable population, as determined by the Investigator (e.g., prisoner or developmentally disabled), that would compromise ability to provide informed consent or compliance with follow-up requirements\n* Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible\n* Use of any other investigational drug or medical device within the last 30 days prior to surgery\n* Pending personal litigation relating to spinal injury (worker's compensation is not exclusionary)\n* Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.","ALL","18 Years",{"count":71,"type":72},225,"ESTIMATED","INTERVENTIONAL",[75],"NA","The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF) procedures.\n\nThe primary outcome measure is the rate of fusion success in the investigational treatment arm (ACDF + PCF) compared with the control arm (ACDF alone) at the 12-month follow-up visit.\n\nResearchers will compare the investigational treatment arm (ACDF + PCF) to the control arm (ACDF alone) to assess superiority in terms of fusion success rate.",[78],"Degenerative Disc Disease(DDD)",[80,81,82,83,84,85,86,28],"cervical spine","myelopathy","radiculopathy","cervical spine fusion","circumferential cervical fusion","degenerative disc disease","2-Level Cervical Degenerative Disease","NOT_YET_RECRUITING","2026-07-17",{"date":90,"type":91},"2026-07-23","ACTUAL",{"date":93,"type":72},"2026-06-30",{"date":95,"type":72},"2029-12-01",{"name":5,"class":6},1]