Clinical trial NCT06223737: Spine Deformity Patients With Optoelectronic Motion Capture
Official title: Characterization of Patients Suffering From Adult Spine Deformities With Optoelectronic Motion Analysis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spine Deformity
Keywords: Adult Spine Deformity
Surgical Planning
Spinal Deformity
Optoelectronic Motion Analysis
Biplanar Radiography
Absolute Spinal Curvature
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: Bern University of Applied Sciences
First posted: 2024-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions
timeFrame: 1-2hours
Secondary outcomes:
measure: investigate and quantify the well-known errors in the assessment of the absolute spinal curvature
timeFrame: 1-2hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Schulthess Klinik
Study officials:
References: