NCT04422288|Completed
MSK Validation Study
MSK
Prediction of Postoperative Global Sagittal Alignment Using Musculoskeletal Modeling - Validation Study
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MSK
Prediction of Postoperative Global Sagittal Alignment Using Musculoskeletal Modeling - Validation Study
Sponsor study identifier
observational
200
1 country
2
Study Start
May 15, 2020
Actual (reported)Primary Completion
October 1, 2022
Actual (reported)Study Completion
October 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 15, 2020
Actual (reported)June 2, 2020
Actual (reported)June 9, 2020
Actual (reported)October 1, 2022
Actual (reported)October 1, 2022
Actual (reported)Difference between model-predicted and observed postural measures - Thoracic Kyphosis (TK)
The simulation-predicted posture will be compared against the posture observed at follow-up, using the thoracic kyphosis (TK) angle.
3 months
Difference between model-predicted and observed postural measures - Lumbar Lordosis (LL)
The simulation-predicted posture will be compared against the posture observed at follow-up, using the LL - lumbar lordosis (LL) angle.
3 Months
Difference between model-predicted and observed postural measures - T1 Pelvic Angle (TPA)
The simulation-predicted posture will be compared against the posture observed at follow-up, using the T1 pelvic angle (TPA).
3 Months
Difference between model-predicted and observed postural measures - Pelvic Incidence-Lumbar Lordosis Mismatch (∆PILL)
The simulation-predicted posture will be compared against the posture observed at follow-up, using the pelvic incidence-lumbar lordosis mismatch (∆PILL).
3 Months
Model sensitivity and specificity in predicting posture imbalance
3 months
At least 186 patients will be enrolled in this multicenter combined observational / in silico study, recruited into 3 groups (at least 62 cases each) according to the number of levels instrumented: 1. local fusion, 1-2 segments; 2. short fusion, 3-4 segments; 3. long fusion, 5+ segments.
University of Colorado
Aurora, Colorado, 80045, United States
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Kyle Malone, MS
NuVasive
200 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2020
First Posted
June 9, 2020
Study Start
May 15, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 1, 2022
Actual (reported)Study Completion
October 1, 2022
Actual (reported)Last Updated
December 22, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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