Skip to main content
OpenTrials
Completed

NCT Number: NCT04422288

MSK Validation Study

Spinal posture and imbalance are known to be related to increased muscle expenditure, with narrow "cone of economy" of muscle effort defining the most comfortable postures. Therefore, it is hypothesized that predicting the posture of the lowest muscle effort available for a patient with a given spinal alignment and body properties will correspond to the posture the patient will most likely assume. Based on established musculoskeletal models, a model application was configured to allow prediction of this optimal posture. This study aims to assess the validity of this approach and the value of using biomechanical modeling for pre-operative planning.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Proximal Junctional Kyphosis Spino-pelvic Alignment Thoracolumbar Spinal Fusion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado, Aurora, Colorado, United States

Loading trial locations.

About this study

The objective of this study is to validate a novel method of post-operative posture prediction - a full-body biomechanical model based on an established technology and physiological reasoning. Specifically, the model ability to predict postoperative global sagittal alignment, including compensatory and reciprocal changes, from pre-operative radiographic imaging and the information about planned posture correction will be evaluated. This will be realized by comparing model-predicted radiographic measures and overall balance to follow-up patient radiographs.

Having demonstrated model validity to predict postoperative posture will allow to use this method for simulating various "what-if" scenarios to empower surgical planning by predicting expected outcomes. This can be used to optimizing preoperative planning, which has a potential to substantially improved surgery predictability and patient outcomes.

Furthermore, validated model will allow scientific investigation of the principles governing human posture and biomechanics of the pathological spine. Generated scientific knowledge of biomechanical factors influencing sagittal posture and surgery outcomes (e.g. number of levels fused, amount and distribution of posture correction, etc.) can lead to improvements in clinical management of spinal disorders.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female patients
  • Any ethnicity
  • At least 18 years of age
  • Has undergone a thoracolumbar spinal fusion procedure

Exclusion criteria

  • Patient has had a prior spinal surgery in the thoracic and/or lumbar spine;
  • Patient presents scoliosis greater or equal to 20° T4-T12 Cobb angle;
  • Patient has been diagnosed with idiopathic adolescent scoliosis (treated or untreated);
  • Patient has other implants that obstruct the spine and/or pelvis in the lateral view;
  • Patient presents any of the following complications: pseudoarthrosis, instrumentation failure, instrumentation pull-out and/or requires a revision surgery at any time following the primary surgery and prior to 3 months post-op;
  • Patient is a prisoner.

Treatment and study plan

Primary outcomes

  1. Difference between model-predicted and observed postural measures - Thoracic Kyphosis (TK)

    Time frame: 3 months

    The simulation-predicted posture will be compared against the posture observed at follow-up, using the thoracic kyphosis (TK) angle.

  2. Difference between model-predicted and observed postural measures - Lumbar Lordosis (LL)

    Time frame: 3 Months

    The simulation-predicted posture will be compared against the posture observed at follow-up, using the LL - lumbar lordosis (LL) angle.

  3. Difference between model-predicted and observed postural measures - T1 Pelvic Angle (TPA)

    Time frame: 3 Months

    The simulation-predicted posture will be compared against the posture observed at follow-up, using the T1 pelvic angle (TPA).

  4. Difference between model-predicted and observed postural measures - Pelvic Incidence-Lumbar Lordosis Mismatch (∆PILL)

    Time frame: 3 Months

    The simulation-predicted posture will be compared against the posture observed at follow-up, using the pelvic incidence-lumbar lordosis mismatch (∆PILL).

Secondary outcomes

  1. Model sensitivity and specificity in predicting posture imbalance

    Time frame: 3 months

    A McNemar's test (a paired Chi-squared test) will be used to test the null hypothesis that the balance prediction is due to chance, allowing to assess if the model predictive power is better than random.

Sponsors and collaborators

Lead sponsor

NuVasive

Industry

Registry information

Official study title

Prediction of Postoperative Global Sagittal Alignment Using Musculoskeletal Modeling - Validation Study

Acronym: MSK

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.