[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100434357":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":60,"collaborators":63,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":26,"enrollmentInfo":81,"targetDuration":26,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Uppsala University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Muscle preserving selective laminectomy (L-group)","EXPERIMENTAL","Muscle-preserving selective laminectomy with a posterior midline incision and dissection through the nuchal fascia. The spinous processes are split in the midline using a high-speed burr\u002Fultrasound knife and without disturbing the deep extensor muscles on either side. Angulating away from the midline, the spinous processes are divided at their bases. Laminectomy is performed with a width no more than 2-3 mm wider than the dural borders. The facet joints are not exposed. Finally, the split spionous processes are sutured together. No collar or restrictions will be used in either group.",[13],"Procedure: Muscle preserving selective laminectomy",{"label":15,"type":16,"description":17,"interventionNames":18},"Laminectomy with instrumented fusion (LF-group)","ACTIVE_COMPARATOR","Laminectomy with instrumented fusion with a midline incision over the appropriate levels defined as the same levels as the extension of laminectomy plus one level above and below but not extending beyond C3-C7. Soft tissue dissection and retraction is performed to identify osseous landmarks. Special care is taken to spare muscle attachments on C2 and C7. Spinal instrumentation is performed with lateral mass or pedicle screws (C3-C7) combined with rod fixation. Laminectomy is performed with a width not extending more than 2 mm outside the dural borders. Facet joint injury should be avoided. Special care is taken to spare the C7 spinous process and distal half of C7 lamina. The sagittal alignment is corrected before spinal fixation. No collar or restrictions will be used in either group.",[19],"Procedure: Laminectomy with instrumented fusion",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Muscle preserving selective laminectomy","Muscle-preserving selective laminectomy differ from traditional laminectomy by the spinous process split that preserves the deep extensor muscles. The bilateral facet joints are not exposed. After the laminectomy is finished the split fragments of the spinous process are sutured together so that the deep extensor muscles are restored.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Laminectomy with instrumented fusion","A traditional laminectomy is complemented with lateral mass and\u002For pedicle screws connected with rods.",[15],[32],{"name":33,"affiliation":5,"role":34},"Anna MacDowall, MD, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+46 730687087","anna.macdowall@surgsci.uu.se",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Adrian Elmi-Terander, MD, PhD","+46 704716766","adrian.elmi-terander@karolinska.se",[45],{"facility":46,"status":47,"city":48,"state":26,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Academic Hospital of Uppsala","RECRUITING","Uppsala","75185","Sweden","SE",{"type":53,"coordinates":54},"Point",[55,56],17.63889,59.85882,{"lat":56,"lon":55},[59],{"name":33,"role":37,"phone":26,"phoneExt":26,"email":39},{"type":34,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Anna Mac Dowall","Consultant",[64,66,69],{"name":65,"class":6},"Karolinska Institutet",{"name":67,"class":68},"Linkoeping University","OTHER_GOV",{"name":70,"class":6},"Sahlgrenska University Hospital","100434357","fusion-or-no-fusion-after-decompression-of-the-spinal-cord-in-patients-with-degenerative-cervical-myelopathy-100434357",false,"NCT04936074","Fusion or no Fusion After Decompression of the Spinal Cord in Patients With Degenerative Cervical Myelopathy","Comparison of Posterior Muscle-preserving Selective Laminectomy and Laminectomy With Fusion for Treating Degenerative Cervical Myelopathy: Myelopathy Randomized Controlled Trial (MyRanC)","MyRanC","Inclusion Criteria:\n\n* Age \\>18 years\n* 1-4 levels of cervical degenerative myelopathy in the subaxial spine, C3-C7, without or with deformity not exceeding exclusion criteria, see below.\n* Eligible for both treatments\n* Ability to understand and read Swedish language\n* Symptomatic myelopathy with at least one clinical sign of myelopathy\n* No previous spine surgery\n* Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures\n* Personally, signed and dated informed consent document prior to any study-related procedures, indicating that the patient has been informed of all pertinent aspects of the trial\n\n  * Definition of kyphosis - cSVA \\> 40 mm and\u002For C2-C7 Cobb \\> 10° kyphosis. Definition of spondylolisthesis - anterior slippage of \\> 2 mm on cervical radiographs taken in the neutral position.\n\nExclusion Criteria:\n\n* Local kyphosis; a modified K-line minimum interval distance (INT) of \\\u003C4 mm\n* Spondylolisthesis \\>4 mm and simultaneous translation \\>2 mm on lateral flexion\u002Fextension radiographs\n* Soft disc herniations only (no signs of osteophyte formation and hypertrophy of the ligamentum flavum)\n* Active infection\n* Neoplasm\n* Trauma\n* Inflammatory disease (i.e., rheumatoid arthritis or ankylosing spondylitis or DISH)\n* Systemic disease including HIV\n* Lumbar or thoracic spinal disease to the extent that surgical consideration is probable or anticipated within 6 months after the cervical surgical treatment (significant lumbar stenosis as defined by Schizas C or worse).\n* OPLL\n* Parkinson´s disease\n* Drug abuse, dementia, or other reason to suspect poor adherence to follow-up\n* Previous cervical spine surgery","ALL","18 Years",{"count":82,"type":83},300,"ESTIMATED","INTERVENTIONAL",[86],"NA","Background:\n\nDegenerative cervical myelopathy (DCM) is characterized by neck pain, neck stiffness, weakness, paresthesia, sphincter disturbance and balance disorder. The mean age for symptoms is 64 years and more men than women, 2.7:1, are affected. The most common level is C5-C6. DCM is the predominant cause of spinal cord dysfunction in the elderly worldwide. Surgical options include stand-alone laminectomy, laminectomy and fusion and laminoplasty. The preferable surgical approach is though, a matter of controversy. The objective of this study is to compare stand-alone laminectomy to laminectomy and fusion.\n\nMethods\u002FDesign:\n\nThis is a multicenter randomized, controlled, parallel group non-inferiority trial. A total of 300 adult participants are allocated in a ratio of 1:1. The primary endpoint is reoperation for any reason within 5 years of follow-up. Sample size and power calculations were performed by estimating the reoperation rate after laminectomy to 3.4% and after laminectomy with fusion to 7.9% based on data from the Swedish spine registry (Swespine) on patients with DCM.\n\nSecondary outcomes are the patient derived modified Japanese orthopaedic association (P-mJOA) score, Neck disability index (NDI), European quality of life five dimensions (EQ-5D), Numeric rating scale (NRS) for neck and arm pain, Hospital anxiety and depression scale (HADS), development of kyphosis measured as the cervical sagittal vertical axis (cSVA) and, death. Clinical and radiological follow-up is performed at 3, 12, 24 and 60 months after surgery. The main inclusion criteria is 1-4 levels of DCM in the subaxial spine, C3-C7, with or without deformity. The REDcap will be used for safe data management. Data will be analyzed in the per protocol (PP) population, defined as randomized patients who are still alive without having emigrated or left the study after five years.\n\nDiscussion:\n\nThis will be the first randomized controlled trial comparing two of the most common surgical treatments for DCM; the posterior muscle-preserving selective laminectomy and posterior laminectomy with instrumented fusion. The results of the MyRanC study will provide surgical treatment recommendations for DCM. This may result in improvements in surgical treatment and clinical practice regarding DCM.",[89],"Cervical Spondylotic Myelopathy",[91,92,93,94,95],"Cervical fusion","Cervical spine","Laminectomy","Spinal surgery","Randomized controlled trial","2025-04-04",{"date":98,"type":99},"2025-04-08","ACTUAL",{"date":101,"type":99},"2022-02-21",{"date":103,"type":83},"2033-02-01",{"name":5,"class":6},1]