Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
NCT ID: NCT00738439
Last Updated: 2024-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
1999 participants
OBSERVATIONAL
2008-10-31
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Operative
Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees requiring surgery.
No interventions assigned to this group
Nonoperative
Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees not requiring surgery.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Sagittal Vertical Axis (SVA) \> 5cm
* Pelvic Tilt \> 25 degrees
* Thoracic kyphosis \> 60 degrees
* Age 18 or greater at the time of enrollment.
Exclusion Criteria
* Age \<18 yrs at time of surgery or initial consultation
18 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
K2M, Inc.
INDUSTRY
NuVasive
INDUSTRY
Zimmer Biomet
INDUSTRY
Orthofix Inc.
INDUSTRY
Shay Bess
OTHER
Responsible Party
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Shay Bess
President, ISSGF
Principal Investigators
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Shay Bess, MD
Role: PRINCIPAL_INVESTIGATOR
Denver International Spine Center
Locations
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Scripps Clinic
La Jolla, California, United States
University of California - Davis
Sacramento, California, United States
University of California - San Francisco Medical Center
San Francisco, California, United States
Denver International Spine Center
Denver, Colorado, United States
Doug Burton, MD
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
NYU Hospital for Joint Diseases
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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References
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Passias PG, Soroceanu A, Scheer J, Yang S, Boniello A, Smith JS, Protopsaltis T, Kim HJ, Schwab F, Gupta M, Klineberg E, Mundis G, Lafage R, Hart R, Shaffrey C, Lafage V, Ames C; International Spine Study Group. Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up. Spine J. 2015 Aug 1;15(8):1756-63. doi: 10.1016/j.spinee.2015.04.007. Epub 2015 Apr 8.
Other Identifiers
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1-08-1850
Identifier Type: -
Identifier Source: org_study_id
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