[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517995":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":34,"centralContacts":35,"locations":44,"responsibleParty":59,"collaborators":34,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":63,"sex":69,"minAge":70,"maxAge":34,"enrollmentInfo":71,"targetDuration":34,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":82,"overallStatus":46,"whyStopped":34,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Balgrist University Hospital","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Indication for decompression, randomization for decompression","ACTIVE_COMPARATOR","microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side",[13],"Procedure: Vertebropexy",{"label":15,"type":16,"description":17,"interventionNames":18},"Indication for decompression, randomization for vertebropexy","EXPERIMENTAL","decompression (see above) and additional stabilization of the spine with a ligament (for instance semitendinosus donor allograft), which connect the postoprior structures (Proc. Spinosus and\u002For Lamina) of the vertebrae . Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia)",[13],{"label":20,"type":10,"description":21,"interventionNames":22},"Indication for fusion, randomization for fusion","decompression (see above) and posterolateral instrumented fusion (arthrodesis) with implantation of pedicle screws, titanium alloy rods across the level of listhesis, an intervertebral fusion device and local autograft as well as DBX (demineralized bone matrix) to improve bony fusion",[13],{"label":24,"type":16,"description":17,"interventionNames":25},"Indication for fusion, randomization for vertebropexy",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"PROCEDURE","Vertebropexy","microsurgical (i.e., the use of a microscope or magnifying glasses during decompression) lumbar laminotomy with partial removal of the medial facet joint by preserving the midline structures (supraspinous-interspinous ligament complex); approach: bilateral or ipsilateral with cross-over to the contralateral side. Additional stabilization of the spine with a ligament (for instance semitendinosus donor allograft), which connect the postoprior structures (Proc. Spinosus and\u002For Lamina) of the vertebrae . Situation-related application of laminar bands or analogous suture material (for instance FiberTape, Arthrex, Naples or Nile Band, K2M, Virginia)",[9,15,20,24],[33],"ligamentous fixation of the spine",null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Mazda Farshad, MD","CONTACT","+413861111","Mazda.Farshad@balgrist.ch",{"name":42,"role":38,"phone":39,"phoneExt":34,"email":43},"Sabrina Catanzaro, RN","Sabrina.Catanzaro@balgrist.ch",[45],{"facility":5,"status":46,"city":47,"state":34,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Zurich","8008","Switzerland","CH",{"type":52,"coordinates":53},"Point",[54,55],8.55,47.36667,{"lat":55,"lon":54},[58],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},{"type":60,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100517995","vertebropexy---randomized-controlled-trial-100517995",false,"NCT06024785","Vertebropexy - Randomized-controlled Trial","Comparison of Ligamentous Fixation Technique (Vertebropexy) Versus Conventional Decompression or Fusion Surgery for Degenerative Lumbar Spinal Disease: A Randomized Controlled Trial","VPRCT","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Single-level or two-level lumbar surgery needed\n* Indication for decompression surgery in patients with spinal canal stenosis and additional stable degenerative listhesis (without facet joint effusion ≥ 2mm)\n* Indication for fusion surgery in patients with spinal canal stenosis and additional unstable degenerative listhesis (facet joint effusion ≥ 2mm), in patients with foraminal stenosis and additional degenerative listhesis, and in patients with segment degeneration of the disc\n* Understanding in German language\n\nExclusion criteria:\n\n* Indication for decompression and\u002For fusion surgery in patients with solely disc herniation, fractures, lytic listhesis, tumor\n* Patients undergoing revision surgery for infection\n* Patients undergoing revision surgery on the same level if bony structures have been removed (e.g. prior laminectomy or midline decompression)\n* Patients undergoing revision surgery in case of prior fusion surgery\n* Inability to understand the study for linguistic or cognitive reasons\n* Anticipated clinical follow-up of less than 6 weeks after inclusion\n* Participation in other clinical trials","ALL","18 Years",{"count":72,"type":73},164,"ESTIMATED","INTERVENTIONAL",[76],"NA","To assess the need for additional fusion surgery versus the risk of a revision surgery in patients with degenerative lumbar spinal disease and to assess efficacy and risk of the ligamentous fixation technique (vertebropexy)",[79,80,81],"Degeneration","Spinal Stenosis","Fusion of Spine",[83,84,85,86,87],"degenerative lumbar spinal disease","decompression","fusion","vertebropexy","ligamentous fixation","2025-02-11",{"date":90,"type":91},"2025-02-13","ACTUAL",{"date":93,"type":91},"2025-01-16",{"date":95,"type":73},"2028-12",{"name":5,"class":6},1]