Spine DeformityNCT06223737
Spine Deformity Patients With Optoelectronic Motion Capture
A study testing EOS x-ray and Motion capture in people with Spine Deformity, run by Schulthess Klinik at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Deformity
- What is being tested?
- EOS x-ray and Motion capture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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°.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Schulthess Klinik
Zurich, 8008
Jana Frangi, MSc, +41443857048, jana.frangi@kws.ch
Jacopo Vitale, Dr., +41443857148, jacopo.vitale@kws.ch
About this study
Official title: Characterization of Patients Suffering From Adult Spine Deformities With Optoelectronic Motion Analysis
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.
Read the 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.
- Conditions
- Spine Deformity
- Being tested
- EOS x-ray, Motion capture
- Keywords
- Adult Spine Deformity, Surgical Planning, Spinal Deformity, Optoelectronic Motion Analysis, Biplanar Radiography, Absolute Spinal Curvature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOS x-rayDiagnostic 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 captureDiagnostic test
Also called Optoelectronic camera system
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Diagnostic Test: EOS x-ray; Diagnostic Test: Motion capture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-2hours
Secondary outcomes (1)
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.
Measured: 1-2hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 May 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, Bern University of Applied Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223737
- Sponsor's protocol ID
- SHPL_Def_00782
- Status last verified
- Nov 2024
- First submitted
- 5 Sep 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Patients Suffering From Adult Spine Deformities With Optoelectronic Motion Analysis
- ClinicalTrials.gov ID
- NCT06223737
- Acronym / sponsor ID
- SHPL_Def_00782
- Conditions
- Spine Deformity
- Keywords
- Adult Spine Deformity, Surgical Planning, Spinal Deformity, Optoelectronic Motion Analysis, Biplanar Radiography, Absolute Spinal Curvature
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- ETH Zurich, Bern University of Applied Sciences
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients non-operated | Active comparator | Diagnostic Test: EOS x-ray, Diagnostic Test: Motion captureEach 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. |
| patients operated | Active comparator | Diagnostic Test: EOS x-ray, Diagnostic Test: Motion captureEach 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 |
| healthy controls | Other | Diagnostic Test: EOS x-ray, Diagnostic Test: Motion captureEach 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- both male and female subjects
- BMI < 30 kg/m2
- cognitively intact
- degenerative spinal deformity presenting with at least one criterion:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EOS x-rayAfter 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 | Diagnostic test | healthy controls, patients non-operated, patients operated |
| Motion captureAlso: Optoelectronic camera systemThe 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 | Diagnostic test | healthy controls, patients non-operated, patients operated |
Primary outcome
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.
1 secondary outcome
investigate and quantify the well-known errors in the assessment of the absolute spinal curvature
Time frame: 1-2hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOS x-ray and Motion capture in people with Spine Deformity, run by Schulthess Klinik at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of using motion analysis systems to characterize spinal alignment and balance in static and dynamic conditions (time frame: 1-2hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.