MSK Validation Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female patients. 2. Any ethnicity. 3. At least 18 years of age. 4. Has undergone a thoracolumbar spinal fusion procedure.

Exclusion Criteria:

1. Patient has had a prior spinal surgery in the thoracic and/or lumbar spine; 2. Patient presents scoliosis greater or equal to 20° T4-T12 Cobb angle; 3. Patient has been diagnosed with idiopathic adolescent scoliosis (treated or untreated); 4. Patient has other implants that obstruct the spine and/or pelvis in the lateral view; 5. 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; 6. Patient is a prisoner.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04422288
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	NuVasive
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kyle Malone, MS
Principal Investigator Affiliation	NuVasive
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Proximal Junctional Kyphosis, Spino-pelvic Alignment, Thoracolumbar Spinal Fusion

Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Colorado, Aurora, Colorado

Status

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University of Colorado

Aurora, Colorado, 80045

Univerisity of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

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Univerisity of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

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