Status:
COMPLETED
MSK Validation Study
Lead Sponsor:
NuVasive
Conditions:
Proximal Junctional Kyphosis
Spino-pelvic Alignment
Eligibility:
All Genders
18+ years
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 hypothesiz...
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. Specifi...
Eligibility Criteria
Inclusion
- Male or female patients
- Any ethnicity
- At least 18 years of age
- Has undergone a thoracolumbar spinal fusion procedure
Exclusion
- 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.
Key Trial Info
Start Date :
May 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04422288
Start Date
May 15 2020
End Date
October 1 2022
Last Update
December 22 2025
Active Locations (2)
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1
University of Colorado
Aurora, Colorado, United States, 80045
2
Univerisity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213