Spine Deformity Patients With Optoelectronic Motion Capture

S

Schulthess Klinik

Status

Not yet enrolling

Conditions

Spine Deformity

Treatments

Diagnostic Test: Motion capture
Diagnostic Test: EOS x-ray

Study type

Interventional

Funder types

Other

Identifiers

NCT06223737
SHPL_Def_00782

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • both male and female subjects

  • BMI < 30 kg/m2

  • cognitively intact

  • degenerative spinal deformity presenting with at least one criterion:

    • Coronal Cobb angle ≥20°
    • sagittal vertical axis (SVA) ≥5 cm
    • thoracic kyphosis (TK) ≥60°
    • pelvic tilt (PT) ≥25°.

Exclusion criteria

  • 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
  • inability to give consent.

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

30 participants in 3 patient groups

patients non-operated
Active Comparator group
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.
Treatment:
Diagnostic Test: EOS x-ray
Diagnostic Test: Motion capture
patients operated
Active Comparator group
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
Treatment:
Diagnostic Test: EOS x-ray
Diagnostic Test: Motion capture
healthy controls
Other group
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
Treatment:
Diagnostic Test: EOS x-ray
Diagnostic Test: Motion capture

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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