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

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ClinicalTrials.gov Identifier: NCT00738439
Recruitment Status : Enrolling by invitation
First Posted : August 20, 2008
Last Update Posted : October 11, 2017
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Estimated Enrollment : 936 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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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
Principal Investigator: Shay Bess, MD Denver International Spine Center
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Shay Bess, President, ISSGF, International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT00738439     History of Changes
Other Study ID Numbers: 1-08-1850
First Posted: August 20, 2008    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Keywords provided by Shay Bess, International Spine Study Group Foundation:
scoliosis
kyphosis
treatment outcomes
spinal deformity

Additional relevant MeSH terms:
Congenital Abnormalities