[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07721493":3,"trial-entities:NCT07721493":122,"trial-summary:NCT07721493":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":15,"eligibility_criteria":56,"std_ages":94,"locations":97,"central_contacts":107,"overall_officials":117,"references":120,"see_also_links":121},"NCT07721493","CLN-PMT-149","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","NOT_YET_RECRUITING","2029-12-01","2026-07","2026-07-23","2026-06-30","Providence Medical Technology, Inc.","INDUSTRY",false,"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.","Degenerative disc disease (DDD) of the neck occurs when the discs between the bones of the spine wear down over time. These discs normally act as cushions and help the neck move. When they break down, the space between the bones can narrow and put pressure on nearby nerves or the spinal cord. This can cause pain in the neck, shoulders, and arms.\n\nOne common surgical treatment is called Anterior Cervical Discectomy and Fusion (ACDF). In this procedure, the surgeon approaches the spine from the front of the neck, removes the damaged disc, relieves pressure on the nerves, and fuses the bones together. Another option is Posterior Cervical Fusion (PCF), which is done from the back of the neck. In some cases, both procedures are combined to provide more stability and support healing. The purpose of this study is to evaluate whether combining ACDF and PCF leads to better outcomes than ACDF alone in patients with two-level cervical degenerative disc disease.\n\nParticipants in this study will be assigned to one of two groups:\n\nOne group will receive ACDF alone (standard treatment) The other group will receive a combination of ACDF and PCF (investigational treatment) The main goal of the study is to compare how well the bones fuse together in each group at 12 months after surgery. The study will assess whether the combined approach (ACDF + PCF) results in a higher rate of successful fusion compared to ACDF alone.",[19],"Degenerative Disc Disease(DDD)",[21,22,23,24,25,26,27,28],"cervical spine","myelopathy","radiculopathy","cervical spine fusion","circumferential cervical fusion","degenerative disc disease","2-Level Cervical Degenerative Disease","Anterior Cervical Discectomy and Fusion","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},225,"ESTIMATED",[37,42],{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","Circumferential Cervical Fusion (CCF)","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).",[39],{"type":43,"name":28,"description":44,"armGroupLabels":45},"PROCEDURE","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.",[46],"Anterior Cervical Discectomy and Fusion (ACDF)",[48],{"measure":49,"description":50,"timeFrame":51},"Superiority in Fusion Success in Treatment Arm (CCF) Compared to Control Arm (ACDF)","Superiority in the rate of fusion success in the treatment arm (CCF) as compared to the control arm (ACDF) at the 12-month visit. An individual subject is considered a fusion success if there is evidence of bridging trabecular bone across endplates at all levels treated with no re-intervention.","12 months",[],"ALL","18 Years",null,{"inclusion":57,"exclusion":65,"raw_text":93},[58,59,60,61,62,63,64],"At least 18 years of age (Skeletally Mature)","Indicated for ACDF treatment of degenerative disc disease (DDD) between and including C3-C7 at 2 contiguous levels as determined by the following:","NDI Score of ≥ 15\u002F50","Unresponsive to non-operative, conservative treatment (rest, heat, electrotherapy, physical therapy, chiropractic care and\u002For analgesics) for:","Reported to be medically cleared for surgery","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;","Written informed consent provided by subject.",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92],"Has, in the Investigator's opinion, any disease or condition that would preclude accurate radiographic evaluation of any treated vertebrae (e.g. morbid obesity)","Active systemic infection or infection at the operative site","History of or anticipated treatment for active systemic infection, including HIV or Hepatitis C","Previous trauma to the C3 to C7 levels resulting in significant bony or disco-ligamentous cervical spine injury that may prevent device placement","A prior spine surgery or pseudoarthrosis at the operative levels","Axial neck pain in the absence of other symptoms of radiculopathy or myeloradiculopathy justifying the need for surgical intervention","Symptomatic DDD or significant cervical spondylosis at more than two levels","Diagnosis of Spondylolisthesis, grade \\>2","Overt (Segmental) instability measured as a movement on dynamic flex\u002Fextend x-rays \\> 3.5 mm","Congenital bony and\u002For spinal cord abnormalities that affect spinal stability","Diagnosis of Paget's disease, osteomalacia, or any other metabolic bone disease other than osteopenia","Osteoporosis, defined as either the SCORE or MORES ≥ 6 and a DEXA bone density measured T-score of ≤ -2.5","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","Has an uncontrolled seizure disorder","Use of epidural steroids within 14 days prior to surgery","A concomitant condition requiring daily, high-dose oral and\u002For inhaled steroids. High dose steroid use is defined as:","Known allergy to titanium (Ti)","Fixed or permanent neurologic deficit related to the target treatment levels that cannot be improved with surgical decompression","Has, in the Investigator's opinion, any disease or condition that would preclude accurate clinical evaluation (e.g. neuromuscular disorders)","Is pregnant or nursing at time of screening, or with plans to become pregnant throughout the duration of the study.","A current or recent history (≤ 1 year prior to screening) of substance abuse (alcoholism and\u002For narcotic addiction) that required treatment","Long term use (\\>6 months) of opioids (max. daily amount=120 mg morphine equivalents)","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","Any other condition or anatomy (e.g. fused facet) that makes posterior fusion treatment infeasible","Use of any other investigational drug or medical device within the last 30 days prior to surgery","Pending personal litigation relating to spinal injury (worker's compensation is not exclusionary)","Anticipated or potential relocation greater than 50 miles that may interfere with completion of follow-up examinations.","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.",[95,96],"ADULT","OLDER_ADULT",[98],{"facility":99,"city":100,"state":101,"zip":102,"country":103,"geoPoint":104},"The Orthopaedic Institute","Paducah","Kentucky","42001","United States",{"lat":105,"lon":106},37.08339,-88.60005,[108,113],{"name":109,"role":110,"phone":111,"email":112},"Matt Jenkins","CONTACT","805-450-4965","mjenkins@providencemt.com",{"name":114,"role":110,"phone":115,"email":116},"Stacey Underwood","520-262-3704","sunderwood@providencemt.com",[118],{"name":109,"affiliation":13,"role":119},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":128},[124,125,126,127],"Intervertebral Disc Degenerative Disorder","Myeloradiculopathy","Radiculopathy","Spinal Cord Disorder",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This interventional study plans to enroll 225 participants. It compares two different surgical treatments for degenerative disc disease.","completed","CORUS™ System for 2-level Cervical Degenerative Disease","This study is looking at a new way to treat degenerative disc disease (DDD) in the neck, which happens when the discs between your neck bones wear down. It compares two surgical approaches for two affected levels in your neck. One group will receive the standard Anterior Cervical Discectomy and Fusion (ACDF) procedure. The other group will receive a combination of ACDF and Posterior Cervical Fusion (PCF), using the CORUS™ Posterior Cervical Stabilization System 3D. The main goal is to see if the combined ACDF and PCF treatment leads to better bone fusion after 12 months compared to ACDF alone. You may be eligible if you are at least 18 years old and have been diagnosed with DDD at two specific levels in your neck causing pain or other symptoms. The current recruitment status is unclear.","Participants will be followed for at least 12 months after surgery to assess fusion success.",136,"Not specified in the trial record.","Not stated in the trial record.",[28],"v2"]