[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"spondylolisthesis-lumbar-region\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:spondylolisthesis-lumbar-region":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100570258","adult-patient-outcomes-after-spine-surgery-with-fibergraft-bg-puttyviper-prime-100570258",false,"NCT06704906","Adult Patient Outcomes After Spine Surgery With Fibergraft BG Putty\u002FViper Prime","Assess Clinical and Radiographic Outcomes of VIPER PRIME\u002FExpedium Spine System and Fibergraft BG Putty","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Have a radiograph-based diagnosis of degenerative disc disease, spondylolisthesis, spinal trauma (i.e., fracture or dislocation), spinal stenosis, or deformity (i.e., scoliosis, kyphosis, and\u002For lordosis), spinal tumor, or pseudoarthrosis\u002Ffailed fusion.\n3. Pathology of the thoracolumbar or sacral spine.\n4. Patients requiring fusion of 1-3 levels\n5. Patients receiving the surgery\u002Fdevices as standard of care prescribed by the treating physician.\n\nExclusion Criteria:\n\n1. Patients \\\u003C 18 years\n2. Patients with a cervical spine pathology\n3. Patients with spinal tumors\n4. Patients with bone density (DEXA) scores \\\u003C 2.0 will be excluded.\n5. Current smokers and patients who quit smoking within 6 weeks prior to presentation will be excluded.\n6. Patients with a BMI \\> 40kg\u002Fm2\n7. Patients requiring fusion for more than 3 levels will be excluded","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The Viper Prime\u002FExpedium spine systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracolumbar and sacral spine. The Fibergraft Bioactive Glass (BG) is engineered to mimic the body's natural bone healing process. While previous studies have compared the use of Viper prime\u002FExpedium spine system in minimally invasive and open surgeries, these studies did not specifically study the clinical and radiographic outcomes of patients who have received these implants in addition to Fibergraft. We aim to recruit patients with degenerative disc disease, spondylolisthesis, trauma, and\u002For pseudarthrosis who require spine surgery under standard of care and use these implants. We will then follow these patients for a duration of two years to report their clinical and radiographic outcomes to determine fusion, complication rate, and revision surgeries if any.",[24,25,26],"Spondylolisthesis, Lumbar Region","Spinal Trauma With Neurological Deficit","Degeneration of Lumbar Intervertebral Disc","RECRUITING","2026-01-20",{"date":30,"type":31},"2026-01-22","ACTUAL",{"date":33,"type":31},"2024-12-20",{"date":35,"type":20},"2029-03-30",{"name":37,"class":38},"Nitin Agarwal","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":39},"100526049","self-rehabilitation-at-home-after-lumbar-arthrodesis-sahara-100526049","NCT06129682","Self-rehabilitation At Home After LumbaR Arthrodesis (SAHARA)","Self-rehabilitation At Home After LumbaR Arthrodesis","SAHARA","Inclusion Criteria:\n\n* Lumbar pain and\u002For nerve root pain and\u002For limp without any motor deficiency of the limbs, before and\u002For after surgery (if any motor deficiency occurs after surgery, it will be a secondary exclusion criteria)\n* Surgery for posterolateral lumbar arthrodesis, from a degenerative etiology, from 1 to 3 lumbar levels (one level means one inter-somatic space)\n* Surgery indication after optimal medical treatment, including appropriate pain medicine, and fail of medical treatment for reducing lumbar pain and\u002For nerve root pain and\u002For limp\n* Return home possible after surgery\n* After signing consent during pre-operative visit with the surgeon\n\nExclusion Criteria:\n\n* People under 18 years-old\n* Pregnant or breast-feeding women\n* Psychiatric and\u002For neurodegenerative comorbidity\n* Motor deficiency of the limbs before and\u002For after surgery\n* Iliac extension of arthrodesis\n* Any postoperative complication lengthening stay at hospital\n* Medical contraindication for early rehabilitation",{"count":49,"type":20},120,"INTERVENTIONAL",[52],"NA","Lumbar arthrodesis is more and more common in general population. Patients need early reeducation after surgery but do not always have access to a physiotherapist.\n\nThe investigators aim to study the benefits of self-rehabilitation at home after lumbar arthrodesis, showing amelioration in lumbar pain and in quality of life for concerned patients. For this, the investigators designed a randomized-controlled study to test if self-rehabilitation at home right after surgery is superior than rehabilitation done by a physiotherapist 4 to 6 weeks after surgery (standard treatment for our patients).",[24],"2025-03-14",{"date":57,"type":31},"2025-03-19",{"date":59,"type":31},"2023-12-18",{"date":61,"type":20},"2028-10",{"name":63,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":50,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":39},"100312210","midline-versus-paramedian-approaches-in-treating-degenerative-lumbar-spondylolisthesis-100312210","NCT03344484","Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis","A Pilot Study Comparing Midline Versus Paramedian Approaches to the Lumbar Spine for Single- or Two-Level Fusions in Degenerative Spondylolisthesis","Inclusion Criteria:\n\n* 1\\) surgical candidates with single or two level degenerative spondylolisthesis with the following clinical findings:\n\n  1. a clinical history of back, buttock and leg pain with walking or standing that is improved when lying, sitting or bending forward\n  2. a clinical history of leg symptoms that are greater than or equal to back symptoms with walking or standing\n  3. greater than 6 months of symptoms with failed conservative care\n* 2\\) sufficiently fluent in English to provide informed consent and complete questionnaires with or without the need of an interpreter.\n\nExclusion Criteria:\n\n* 1\\) clinical history of osteoporotic fracture or chronic oral steroid use;\n* 2\\) previous posterior lumbar spinal surgery (excluding prior microdiscectomy); and\n* 3\\) patients who have evidence of neurological disorders that affect physical function (e.g. peripheral neuropathy), neuromuscular disorders (e.g. multiple sclerosis, Parkinson's etc.) or systemic illness (e.g. inflammatory arthritis) that affects physical function",true,{"count":19,"type":20},[52],"For the increasing numbers of patients undergoing fusion procedures for the degenerative lumbar spine, infection and re-operation can negatively impact outcomes. Numerous observational and retrospective reviews have shown advantages to para-median versus midline approaches; however, recent systematic reviews have shown a need for a well-powered, prospective randomized control trials comparing both exposures. As a step towards a long-term goal of an RCT to address this issue, the purpose of this pilot study is to gather initial data to examine whether operative approach impacts the short-term infection rate, re-operation rate, length of stay, and overall costs to the system. Patients deemed appropriate surgical candidates with single or two-level degenerative spondylolisthesis will be approached for participation, and randomized into either the midline or paramedian group. Initial follow-ups will be at 2 and 6 weeks, and 3 months. Infection rates, inpatient and outpatient adverse events, re-operation rates, radiation exposure and costs will be determined. Cost effectiveness analysis will be estimated comparing each procedure using a bottom-up estimation. Post-operative wound infection can have a significant effect on patient short and long term outcomes. If a significant difference in infection rate is demonstrated, as well as lower re-operation rates, shorter stays, and decreased overall costs, adoption of paramedian approaches to single or two-level fusions of the lumbar spine might be suggested, providing fuel for a full-scale RCT.",[24],"2024-08-19",{"date":78,"type":31},"2024-08-21",{"date":80,"type":31},"2018-01-30",{"date":82,"type":20},"2025-12-31",{"name":84,"class":38},"Nova Scotia Health Authority"]