Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

NCT ID: NCT00738439

Last Updated: 2024-03-05

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1999 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2025-09-30

Brief Summary

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The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

Detailed Description

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Conditions

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Spinal Deformity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees
* Sagittal Vertical Axis (SVA) \> 5cm
* Pelvic Tilt \> 25 degrees
* Thoracic kyphosis \> 60 degrees
* Age 18 or greater at the time of enrollment.

Exclusion Criteria

* Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
* Age \<18 yrs at time of surgery or initial consultation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DePuy Spine

INDUSTRY

Sponsor Role collaborator

K2M, Inc.

INDUSTRY

Sponsor Role collaborator

NuVasive

INDUSTRY

Sponsor Role collaborator

Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Orthofix Inc.

INDUSTRY

Sponsor Role collaborator

Shay Bess

OTHER

Sponsor Role lead

Responsible Party

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Shay Bess

President, ISSGF

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

University of California - Davis

Sacramento, California, United States

Site Status

University of California - San Francisco Medical Center

San Francisco, California, United States

Site Status

Denver International Spine Center

Denver, Colorado, United States

Site Status

Doug Burton, MD

Kansas City, Kansas, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

NYU Hospital for Joint Diseases

New York, New York, United States

Site Status

Hospital for Special Surgery

New York, New York, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 25862507 (View on PubMed)

Other Identifiers

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1-08-1850

Identifier Type: -

Identifier Source: org_study_id

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