Multimodal Bio-mechanical Analysis of Adult Spinal Deformity With Sagittal Plane Misalignment

NCT04812730 | Recruiting

• 1 other identifier: S58082
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

A good understanding of the principles of balance is vital to achieve optimal outcomes when treating spinal disorders. A complex interaction of the neuromotor system and muscular recruitment is necessary for ergonomic balance and deliberate displacement of the human body. Sagittal plane misalignment in spinal deformities challenges balance mechanisms used for maintenance of an upright posture. The occurrence of postoperative complications after spinal deformity correction like under-correction of sagittal misalignment, postoperative reciprocal changes in thoracic kyphosis, proximal junctional kyphosis and failure of instrumentation are possibly due to the current state-of-the art inadequate diagnostic work-up. Investigators do not fully understand the roll of vision and exact strategy of recruitment of neuromuscular units (trunk, pelvis, lower limbs) in patients with sagittal plane misalignment during standing and walking. To understand this, a dynamic evaluation of individuals with spinal deformities is needed. Currently there is only very little research performed in the field of clinical balance tests and instrumented movement analysis in patients with spinal deformity. The challenge for future studies is to further unravel the relation between trunk and lower limb movements, grouped into functional movement patterns. Moreover, additional information on trunk and lower limb kinetics and muscle activity (using dynamic electromyography (EMG)) will highly contribute to the understanding of this functional relationship, and will provide more in-depth insights into compensatory mechanisms of the trunk versus the lower limbs and vice versa.

Conditions

Spinal Deformity

Keywords

Sagittal plane misalignment; Trunk and lower limb; Motion analysis; EOS stereo radiography

Outcome Measures

Primary Outcomes (8)

• Health-Related Quality of Life (HRQL) score

  To evaluate the domains related to physical, mental, emotional, and social functioning

  up to 2 years

• Postoperative state of the art radiographic evaluation (EOS/CT)

  To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual

  up to 2 years

• Postoperative state of the art radiographic evaluation (EOS/CT) in correlation with HRQL

  To investigate the correlation of radiographic evaluation with HRQL

  up to 2 years

• 3D motion analysis and balance tests

  3D motion analysis and balance tests are combined to investigate the correlation with the static EOS stereo radiographic evaluation/CT/MRI

  up to 2 years

• 3D motion analysis and balance tests to investigate the dynamic function

  3D motion analysis and balance tests are combined to investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual

  up to 2 years

• 3D motion analysis and balance tests in correlation with HRQL

  3D motion analysis and balance tests are combined to investigate the correlation with HRQL (Health-Related Quality of Life)

  up to 2 years

• Static EOS stereo radiographic evaluation

  To investigate whether a state of the art correction of a spinal deformity causes a change in the dynamic function of the individual

  up to 2 years

• Physical activity

  Physical activity will be measured using a step counter (Garmin, Vivofit 4), which is a feasible and reliable parameter to measure physical activity in spinal surgery patients up to one-year post-op

  up to 2 years

Secondary Outcomes (5)

• Falls Efficacy Scale-International (FES-I)

  up to 2 years

• EuroQol-5D-3L

  up to 2 years

• Mini-Mental State Examination (MMSE)

  up to 2 years

• Karnofsky Performance Score (KPS)

  up to 2 years

• Cumulative Illness Rating Scale

  up to 2 years

Study Arms (4)

ASD with decompensated sagittal misalignment

OTHER

Adults suffering from a spinal deformity with a decompensated sagittal misalignment

Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation

ASD with compensated sagittal misalignment

OTHER

Adults suffering from a spinal deformity with a compensated sagittal misalignment

Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation

ASD without sagittal misalignment

OTHER

Adults suffering from a spinal deformity without a sagittal misalignment

Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Pre- versus postoperative analysis; Other: Reliability of the dynamic evaluation

Control group

OTHER

Asymptomatic adults not suffering from a spinal deformity

Other: 2D versus 3D analysis of EOS stereo radiographic analysis; Other: Static versus dynamic analysis; Other: Reliability of the dynamic evaluation

Interventions

2D versus 3D analysis of EOS stereo radiographic analysis OTHER

The use of EOS stereo radiographic analysis and health related quality of life scores to measure the distance of the center of acoustic meati in the transversal plane with respect to the gravity line

ASD with compensated sagittal misalignment; ASD with decompensated sagittal misalignment; ASD without sagittal misalignment; Control group

Static versus dynamic analysis OTHER

The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms

ASD with compensated sagittal misalignment; ASD with decompensated sagittal misalignment; ASD without sagittal misalignment; Control group

Pre- versus postoperative analysis OTHER

The use of EOS stereo radiographic imaging and motion analysis to understand the compensation mechanisms in trunk, pelvis and lower limbs and the correlation between primary and secondary mechanisms.

ASD with compensated sagittal misalignment; ASD with decompensated sagittal misalignment; ASD without sagittal misalignment

Reliability of the dynamic evaluation OTHER

Repeated measurements of the different aspects of the dynamic evaluation protocol (strenght measurements of trunk muscles, balance evaluation and movement analysis) will serve to evaluate the test-retest reliability and intra-rater reliability of the different protocols

ASD with compensated sagittal misalignment; ASD with decompensated sagittal misalignment; ASD without sagittal misalignment; Control group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological group
• Age \>= 45 years
• Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
• Scoring at least 25 out of 30 on Mini Mental State Examination
• Ability to walk at least 50 meters distance independently without a walking aid
• Sagittal malalignment: PI-LL ≥ 25 degrees; sagittal vertical axis \>5cm; pelvic tilt \>25° and/or thoracic kyphosis \> 60° and/or coronal malalignment: thoracic scoliosis 30 ≥ degrees; thoracolumbar/lumbar scoliosis ≥ 30 degrees; global coronal malalignment \>3cm, posterior spinal fusion \> 4 levels + iliac fixation.
• Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
• Completed patient informed consent
• Control group
• Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium
• Age \>=45 years old
• Scoring at least 27 out of 30 on Mini Mental State Examination
• Ability to walk at least 1000 meters distance independently without a walking aid
• Ability and willingness of patient to attend follow-up visits and complete patient questionnaires
• Completed patient informed consent

You may not qualify if:

• Pathological group
• Age \< 45 years old
• Absence of adult spinal deformity
• Scoring less than 25 out of 30 on Mini Mental State Examination
• Non-ability to walk at least 50 meters distance independently, with or without a walking aid.
• Missing patient informed consent
• Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion
• Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\> 3 cm)
• BMI\>30
• Control group
• Age \< 45 years old
• Backpain and/or Sciatica at time of the study
• Presence of adult spinal deformity leading to a pathological sagittal alignment
• Scoring less than 27 out of 30 on Mini Mental State Examination
• Non-ability to walk at least 1000 meters distance independently without a walking aid

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

Study Officials

• Lieven Moke

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Moke

CONTACT

+32 16 34 08 84; lieven.moke@uzleuven.be

Lennart Scheys

CONTACT

+32 16 34 08 85; lennart.scheys@uzleuven.be

Study Design

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

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 24, 2021
• Study Start: January 1, 2016
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)