Spine Deformity Patients With Optoelectronic Motion Capture

ConditionSpine Deformity

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorSchulthess Klinik

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

both male and female subjects

BMI < 30 kg/m2

cognitively intact

Coronal Cobb angle ≥20°

Disqualifiers

age under 18 years or over 75 years

any prior spinal surgery or other musculoskeletal surgery having an impact on movement

pregnancy

inability to perform the planned set of daily activities

Trial design

Design model

Factorial

Treatments tested in this trial

EOS x-ray
Diagnostic test
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
Motion capture
Diagnostic test
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

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: patients non-operatedActive comparator 2 interventions

Group B: patients operatedActive comparator 2 interventions

Group C: healthy controlsOther 2 interventions

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Schulthess Klinik

Lead sponsor

ETH Zurich

Collaborator

Bern University of Applied Sciences