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Clinical Trials/NCT06223737
NCT06223737
Not Yet Recruiting
N/A

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

Schulthess Klinik1 site in 1 country30 target enrollmentMay 1, 2025
ConditionsSpine Deformity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Spine Deformity
Sponsor
Schulthess Klinik
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 1, 2025
End Date
December 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions

Time Frame: 1-2hours

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.

Secondary Outcomes

  • investigate and quantify the well-known errors in the assessment of the absolute spinal curvature(1-2hours)

Study Sites (1)

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