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Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry (PON)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00738439
Recruitment Status : Active, not recruiting
First Posted : August 20, 2008
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
DePuy Spine
K2M, Inc.
NuVasive
Zimmer Biomet
Orthofix Inc.
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation

Study Description
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Brief Summary:
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

Condition or disease
Spinal Deformity

Study Design
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Study Type : Observational
Actual Enrollment : 1999 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Study Start Date : October 2008
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023
Groups and Cohorts
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Group/Cohort
Operative
Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees requiring surgery.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Radiographic [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]
    Coronal and Sagittal views of the spine


Secondary Outcome Measures :
  1. Clinical outcomes [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]
    physical examination/pain scale

  2. Health related quality of life [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]
    Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional)


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients greater than 18 years of age who meet inclusion criteria.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738439


Locations
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United States, California
Scripps Clinic
La Jolla, California, United States, 92037
University of California - Davis
Sacramento, California, United States, 95817
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Colorado
Denver International Spine Center
Denver, Colorado, United States, 80218
United States, Kansas
Doug Burton, MD
Kansas City, Kansas, United States, 66160-7387
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-0882
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10010
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor Scoliosis Center
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Shay Bess
DePuy Spine
K2M, Inc.
NuVasive
Zimmer Biomet
Orthofix Inc.
Investigators
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Principal Investigator: Shay Bess, MD Denver International Spine Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shay Bess, President, ISSGF, International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT00738439    
Other Study ID Numbers: 1-08-1850
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Keywords provided by Shay Bess, International Spine Study Group Foundation:
scoliosis
kyphosis
treatment outcomes
spinal deformity
Additional relevant MeSH terms:
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Congenital Abnormalities