[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"degenerative-disc-diseaseddd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:degenerative-disc-diseaseddd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"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":20,"type":21},225,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Degenerative Disc Disease(DDD)",[29,30,31,32,33,34,35,36],"cervical spine","myelopathy","radiculopathy","cervical spine fusion","circumferential cervical fusion","degenerative disc disease","2-Level Cervical Degenerative Disease","Anterior Cervical Discectomy and Fusion","NOT_YET_RECRUITING","2026-07-17",{"date":40,"type":41},"2026-07-23","ACTUAL",{"date":43,"type":21},"2026-06-30",{"date":45,"type":21},"2029-12-01",{"name":47,"class":48},"Providence Medical Technology, Inc.","INDUSTRY",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":49},"100602735","comparison-of-clinical-outcomes-complications-rate-and-treatment-costs-of-mini-tlif-and-midlif-in-the-treatment-of-discogenic-low-back-pain-100602735","NCT07127380","Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain","MID-MIS Trail Protocol - Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain","MID-MIS","Inclusion Criteria:\n\n* Discogenic lower lumbar-sacral pain lasting longer than one year\n* Failure of conservative treatment, including rehabilitation and pain management\n* Lumbar discopathy qualified for interbody fusion and pedicle screw stabilization\n* Informed consent of the patient for the study and proposed treatment\n\nExclusion Criteria:\n\n* Contraindications to surgery under general anesthesia\n* Age \\\u003C 18 years\n* Pregnancy, breastfeeding\n* Lack of informed consent to participate in the study\n* Lumbar-sac discopathy requiring surgical treatment at more than two levels\n* Spinal deformities: adult idiopathic scoliosis, degenerative scoliosis, deformity due to spinal malignancy, inflammatory spinal disease, post-traumatic, or associated with congenital anomalies\n* Lower lumbar-sacral pain syndrome, which, in the investigator's opinion, has an etiology other than degenerative spine disease (e.g., cancer-related pain, ankylosing spondylitis)\n* Spinal oncology disease\n* True and degenerative spondylolisthesis\n* Contraindications to performing MRI of the lumbar-sacral spine",{"count":59,"type":21},100,[24],"Background\n\nDegenerative disc disease (DDD) is the leading cause of lower back pain and disability, which prevalence increasing with age. When conservative treatment fails, surgical methods of spinal fusion are employed. Minimally invasive techniques, including minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF) and midline lumbar interbody fusion (MIDLIF), have well-documented advantages over traditional open transforaminal interbody fusion (open-TLIF). However, data comparing these two minimally invasive methods in treating DDD are minimal and sometimes contradictory. I am running a few minutes late; my previous meeting is running over.\n\nMethods This is a prospective, randomized, partially blinded, two-arm trial aiming to compare the outcomes, complications, and treatment costs of MIS-TLIF and MIDLIF in patients with discogenic low back pain. A total of 100 adult patients with lumbosacral spine pain and radicular symptoms, unresponsive to conservative treatment for over one year, will be enrolled. Patients will be randomized (1:1) into two arms: MIS-TLIF (control, n=50) and MIDLIF (intervention, n=50), with a 12-month follow-up. Inclusion criteria include age ≥18 years and discopathy at one or two levels requiring interbody stabilization. Exclusion criteria include multilevel pathology, spinal deformities, and pain causes other than degenerative disease. Primary endpoints assess pain (VAS, NRS scales), disability (COMI, ODI questionnaires), and quality of life (EQ-5D-5L questionnaire) at 1, 3, 6, and 12 months post-surgery. Secondary endpoints include complication rates (nerve root damage, infections), costs (hospitalization, implants), length of hospital stay, procedure duration, blood loss, morphometric parameters (intervertebral space height), and adjacent segment disease based on imaging studies (MRI, CT, X-ray). Data analysis uses parametric\u002Fnon-parametric tests (e.g., t-test, Mann-Whitney) in the R software. The trial adheres to the Helsinki Declaration, with ethics approval (no. 112\u002F2024).\n\nDiscussion Data on the comparison of MIDLIF and MIS-TLIF in treating DDD are minimal and inconsistent. Some reports have advantaged MIDLIF in shorter operative time, decreased intraoperative blood loss, and reduced hospital stays, while others favor MIS-TLIF. This trial addresses these gaps by providing high-quality evidence on clinical superiority, cost-effectiveness, and long-term outcomes compering MIDLIF and MIS-TLIF. There is a high need for a high-quality, prospective study to examine this problem.",[63,64,65,27],"Lower Back Pain Chronic","Lumbar Degenerative Disease","Lumbar Disc Degeneration",[67,68,65,69,70,71,72,73,74,75,76],"Degenerative Disc Disease","Lower Back Pain","Discogenic Pain","MIS-TLIF","MIDLIF","mini-TLIF","Minimally Invasive Transforaminal Lumbar Interbody Fusion","Midline Lumbar Interbody Fusion","Spinal stabilization","Spinal fusion","RECRUITING","2026-04-14",{"date":80,"type":41},"2026-04-15",{"date":82,"type":41},"2025-01-19",{"date":84,"type":21},"2028-01-31",{"name":86,"class":87},"Copernicus Memorial Hospital","OTHER"]