MSK Validation Study (MSK)

December 16, 2025 updated by: NuVasive

Prediction of Postoperative Global Sagittal Alignment Using Musculoskeletal Modeling - 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Univerisity of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months
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 Months
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).
3 Months
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).
3 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NuVasive

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Kyle Malone, MS, NuVasive

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 2, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 4, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NUVA.MSK1901

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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