MSK Validation Study

NCT04422288 | Completed

• 1 other identifier: NUVA.MSK1901
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Thoracolumbar Spinal Fusion; Spino-pelvic Alignment; Proximal Junctional Kyphosis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Model sensitivity and specificity in predicting posture imbalance

  3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NuVasive: lead

Study Sites (2)

University of Colorado

Aurora, Colorado, 80045, United States

Location

Univerisity of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2020
• First Posted: June 9, 2020
• Study Start: May 15, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (2)