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Not Yet RecruitingNCT06223737

Spine Deformity Patients With Optoelectronic Motion Capture

Characterization of Patients Suffering From Adult Spine Deformities With Optoelectronic Motion Analysis

Status
Not Yet Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Schulthess Klinik · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTEOS x-rayAfter 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
DIAGNOSTIC_TESTMotion captureThe 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

Timeline

Start date
2025-05-01
Primary completion
2026-04-30
Completion
2026-12-30
First posted
2024-01-25
Last updated
2024-11-29

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT06223737. Inclusion in this directory is not an endorsement.