An interventional study of EOS x-ray and Motion capture in Spine Deformity, sponsored by Schulthess Klinik. Not yet recruiting at 1 site in Switzerland. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by Schulthess Klinik · Not applicable, Interventional, and Screening
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.
This 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.
The 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.
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.
Precise 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.
Limitations 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.
This 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.
The 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.
The 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.
Schulthess Klinik is the lead sponsor of 53 studies on the registry; 11 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
degenerative spinal deformity presenting with at least one criterion:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Diagnostic Test: EOS x-ray · Diagnostic Test: Motion capture
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
Diagnostic Test: EOS x-ray · Diagnostic Test: Motion capture
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
Diagnostic Test: EOS x-ray · Diagnostic Test: Motion capture
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
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. The 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). Tasks: standing, maximal flexion-extension, lateral bending, axial rotation, lifting, holding load, walking, step up, sitting and sit-to-stand
Also known as: Optoelectronic camera system
Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions
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.
Time frame: 1-2hours
investigate and quantify the well-known errors in the assessment of the absolute spinal curvature
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.
Time frame: 1-2hours
Start is estimated for May 2025; primary completion for Apr 2026, 11 months later.
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Schulthess Klinik