Nctid:
NCT06223737
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000013", "term"=>"Congenital Abnormalities"}], "browseLeaves"=>[{"id"=>"M12", "name"=>"Congenital Abnormalities", "asFound"=>"Deformity", "relevance"=>"HIGH"}, {"id"=>"M15918", "name"=>"Spinal Curvatures", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NON_RANDOMIZED", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"SCREENING", "interventionModel"=>"FACTORIAL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>30}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-06-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-12-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-16", "studyFirstSubmitDate"=>"2023-09-05", "studyFirstSubmitQcDate"=>"2024-01-16", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-09-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions", "timeFrame"=>"1-2hours", "description"=>"This primary outcome investigation focuses on assessing key spinal parameters, including lumbar lordosis, pelvic tilt, thoracic kyphosis, and the severity of scoliosis, in static conditions. Additionally, the study captures the same variables during the performance of common daily activities, such as gait, maximal flexion, trunk torsion, lifting loads, walking with loads, and sit-to-stand transitions. The goal is to understand the feasibility of using optoelectronic motion analysis to provide comprehensive insights into spinal alignment and balance for both operated and non-operated adult spine deformity patients."}], "secondaryOutcomes"=>[{"measure"=>"investigate and quantify the well-known errors in the assessment of the absolute spinal curvature", "timeFrame"=>"1-2hours", "description"=>"The secondary outcome investigation focuses on exploring and quantifying known errors associated with the assessment of absolute spinal curvature, particularly when soft tissue markers are employed. The study aims to develop strategies to compensate for these errors, considering the challenges posed by attaching markers on top of soft tissues. The objective is to enhance the accuracy of spinal curvature measurements obtained through optoelectronic motion analysis, contributing to improved surgical planning for adult spine deformity cases."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Adult Spine Deformity", "Surgical Planning", "Spinal Deformity", "Optoelectronic Motion Analysis", "Biplanar Radiography", "Absolute Spinal Curvature"], "conditions"=>["Spine Deformity"]}, "descriptionModule"=>{"briefSummary"=>"Aging-induced changes in the spine can lead to adult spinal deformity, causing a forward and/or lateral shift of the trunk. While mild cases may have compensatory mechanisms, severe deformities necessitate treatment. Surgery with instrumentation effectively corrects deformities, but complications are common. Precise pre-operative planning based on X-rays is essential. However, radiological imaging has limitations, including ionizing radiation exposure and static nature. Marker-based optoelectronic motion analysis systems offer potential benefits for dynamic spine assessment.\n\nThis study aims to test the feasibility of using motion analysis systems to characterize spinal alignment and balance in patients with adult spine deformity. The primary objective is to assess the practical implementation, measurement capability, and resources required for motion analysis. Secondary objectives include investigating errors in absolute spinal curvature assessment and developing compensation strategies.\n\nThe project will recruit 20 patients (non-operated and operated) seeking medical attention for adult spine deformities and 10 healthy controls. Participants will undergo biplanar imaging and motion analysis to capture static and dynamic spine alignment during common activities. The data will help build patient-specific musculoskeletal models, offering potential insights into improving surgical planning for adult spine deformities.", "detailedDescription"=>"Aging and degeneration can lead to changes in the spine, causing adult spinal deformities like loss of lumbar lordosis, thoracic hyperkyphosis, and scoliosis. Severe deformities can be highly debilitating, necessitating treatments. Surgery using instrumentation, such as pedicle screws, rods, and cages, can effectively correct adult spine deformities. However, complications and failures are common.\n\nPrecise pre-operative planning based on standing X-rays is crucial before attempting correction. Radiographic parameters, including pelvic incidence (PI), sagittal vertical axis (SVA), lumbar lordosis, thoracic kyphosis, coronal Cobb angles, and vertebral rotation, are measured to evaluate the patient's standing posture and compensatory mechanisms.\n\nLimitations in traditional radiological imaging for spinal alignment assessment include ionizing radiation exposure and lack of information on dynamic spine responses during various activities. To address these limitations, marker-based optoelectronic motion analysis systems have been proposed to characterize dynamic spinal alignment and movement during different activities. This technology has shown promise in assessing spinal curvature changes reliably.\n\nThis research aims to investigate the feasibility of using optoelectronic motion analysis systems to characterize spinal alignment and balance in patients with adult spine deformity. The primary objective is to assess the practical implementation, measurement capability, and resources required for motion analysis. Secondary objectives include exploring potential strategies to compensate for errors in absolute spinal curvature assessment due to markers on soft tissue.\n\nThe study will recruit 20 patients seeking medical attention for adult spine deformities (divided into non-operated and operated subgroups) and 10 healthy controls. Participants will undergo biplanar imaging and motion analysis to capture static and dynamic spine alignment during various activities. The data obtained will be used to build patient-specific musculoskeletal models, offering potential insights into improving surgical planning for adult spine deformities.\n\nThe findings of this study may lead to advancements in understanding spinal deformities and help in developing personalized treatment strategies to improve outcomes for patients suffering from adult spine deformities."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"75 years", "minimumAge"=>"18 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* both male and female subjects\n* BMI \\< 30 kg/m2\n* cognitively intact\n* degenerative spinal deformity presenting with at least one criterion:\n\n * Coronal Cobb angle ≥20°\n * sagittal vertical axis (SVA) ≥5 cm\n * thoracic kyphosis (TK) ≥60°\n * pelvic tilt (PT) ≥25°.\n\nExclusion Criteria:\n\n* age under 18 years or over 75 years\n* any prior spinal surgery or other musculoskeletal surgery having an impact on movement\n* pregnancy\n* inability to perform the planned set of daily activities\n* inability to give consent."}, "identificationModule"=>{"nctId"=>"NCT06223737", "briefTitle"=>"Spine Deformity Patients With Optoelectronic Motion Capture", "organization"=>{"class"=>"OTHER", "fullName"=>"Schulthess Klinik"}, "officialTitle"=>"Characterization of Patients Suffering From Adult Spine Deformities With Optoelectronic Motion Analysis", "orgStudyIdInfo"=>{"id"=>"SHPL_Def_00782"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"patients non-operated", "description"=>"Each patient will be measured for an EOS x-ray and at the human performance lab at the clinic for optoelectronic motion capture of the spinal movements.", "interventionNames"=>["Diagnostic Test: EOS x-ray", "Diagnostic Test: Motion capture"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"patients operated", "description"=>"Each patient will be measured for an EOS x-ray and at the human performance lab at the clinic for optoelectronic motion capture of the spinal movement", "interventionNames"=>["Diagnostic Test: EOS x-ray", "Diagnostic Test: Motion capture"]}, {"type"=>"OTHER", "label"=>"healthy controls", "description"=>"Each participant will be measured as control group for an EOS x-ray and at the human performance lab at the clinic for optoelectronic motion capture of the spinal movement", "interventionNames"=>["Diagnostic Test: EOS x-ray", "Diagnostic Test: Motion capture"]}], "interventions"=>[{"name"=>"EOS x-ray", "type"=>"DIAGNOSTIC_TEST", "description"=>"After marking the anatomical landmarks where later on skin markers will be placed, radiopaque markers are attached for the radiographic examination with the EOS system. Images are taken from the positions standing and sitting", "armGroupLabels"=>["healthy controls", "patients non-operated", "patients operated"]}, {"name"=>"Motion capture", "type"=>"DIAGNOSTIC_TEST", "otherNames"=>["Optoelectronic camera system"], "description"=>"The used marker set is the IfB marker set (List et al. 2013), consisting of 40 skin markers on the lower extremities, 7 on the pelvis, 24 on the trunk and 6 on the upper extremities. For the later musculoskeletal modelling the IfB marker set is extended with 7 additional markers on the spinal thoracic processes. All markers will be placed by skilled operators.\n\nThe test procedure consists of six trials, namely a standing trial in an anatomic upright position and a calibration motion as well as four basic motion tasks to define functional estimated joint axis, respectively centers (each performed twice).\n\nTasks: standing, maximal flexion-extension, lateral bending, axial rotation, lifting, holding load, walking, step up, sitting and sit-to-stand", "armGroupLabels"=>["healthy controls", "patients non-operated", "patients operated"]}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Schulthess Klinik", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"ETH Zurich", "class"=>"OTHER"}, {"name"=>"Bern University of Applied Sciences", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"SPONSOR"}}}}
