[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100268378":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":28,"collaborators":24,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":24,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":24,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":51,"overallStatus":56,"whyStopped":24,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":24},{"fullName":5,"class":6},"Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Brace Group","ACTIVE_COMPARATOR","Patients in the brace group will be fitted by an orthotist postoperatively and will be instructed to wear a rigid molded Lumbosacral Orthosis (LSO) full time for 8 weeks except during hygiene and wound care followed by daytime wear for another 4 weeks. All patients will start wearing the brace 48 hours after the surgery following removal of the wound drain. All braces will be molded and fitted by the same experienced orthotist affiliated with the hospital. Self-compliance to brace wear will be noted every day for 3 months by each patient on a specific form.",[13],"Other: Brace Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","EXPERIMENTAL","No brace prescription postoperatively. Patients in this group will be observed and results will be compared to the brace group.",[19],"Other: Control Group",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.\n\nAll patients will complete the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (preoperatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.\n\nBracing will not be prescribed postoperatively for this group. All patients will the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (pre-operatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care.",[15],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Jean-Marc Mac-Thiong","MD, PhD","100268378","the-early-impact-of-postoperative-bracing-on-pain-and-quality-of-life-following-posterior-instrumented-fusion-for-lumbar-degenerative-conditions-100268378",false,"NCT02773134","The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions","The Early Impact of Postoperative Bracing on Pain and Quality of Life Following Posterior Instrumented Fusion for Lumbar Degenerative Conditions: A Randomized Trial","Inclusion Criteria:\n\n* Patients with degenerative lumbar spine disease (degenerative spondylolisthesis, spinal stenosis, or degenerative disc disease);\n* Patients scheduled for an elective posterior spinal fusion.\n\nExclusion Criteria:\n\n* Patients with obesity (BMI \\> 35kg\u002Fm2).","ALL","18 Years","66 Years",{"count":43,"type":44},43,"ACTUAL","INTERVENTIONAL",[47],"NA","Braces are commonly prescribed after posterior spinal instrumented fusion (PSIF) in patients with lumbar degenerative conditions with the aim of improving pain relief and quality of life. However, there is a lack of evidence on the indication for postoperative bracing, as surgeons choose to use braces mainly based on their experience and training.\n\nThe aim of this study is to investigate whether wearing a brace after PSIF can improve pain relief and quality of life (QOL) 6 weeks and 3 months after surgery.",[50],"Lumbar Degenerative Conditions",[52,53,54,55,50],"Post-operative Bracing","Rigid Lumbosacral Orthosis","Posterior Spine Fusion","Quality of Life","COMPLETED","2025-11-21",{"date":59,"type":44},"2025-11-26",{"date":61,"type":24},"2009-03",{"date":63,"type":44},"2016-05",{"name":5,"class":6}]