Spine Deformity Patients With Optoelectronic Motion Capture

NCT06223737 | Not Yet Recruiting DMC

• 1 other identifier: SHPL_Def_00782
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Spine Deformity

Keywords

Adult Spine Deformity; Surgical Planning; Spinal Deformity; Optoelectronic Motion Analysis; Biplanar Radiography; Absolute Spinal Curvature

Outcome Measures

Primary Outcomes (1)

• 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.

  1-2hours

Secondary Outcomes (1)

• investigate and quantify the well-known errors in the assessment of the absolute spinal curvature

  1-2hours

Study Arms (3)

patients non-operated

ACTIVE COMPARATOR

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.

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

patients operated

ACTIVE COMPARATOR

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

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

healthy controls

OTHER

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

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

Interventions

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

healthy controls; patients non-operated; patients operated

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

Also known as: Optoelectronic camera system

healthy controls; patients non-operated; patients operated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Schulthess Klinik: lead
• ETH Zurich: collaborator
• Bern University of Applied Sciences: collaborator

Study Sites (1)

Schulthess Klinik

Zurich, 8008, Switzerland

Location

MeSH Terms

Interventions

Motion Capture

Intervention Hierarchy (Ancestors)

Diagnostic Tests, Routine; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: January 25, 2024
• Study Start: May 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Locations

CH (1)