Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry (PON)
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ClinicalTrials.gov Identifier: NCT00738439 |
Recruitment Status :
Active, not recruiting
First Posted : August 20, 2008
Last Update Posted : February 3, 2021
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Condition or disease |
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Spinal Deformity |
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 |
Group/Cohort |
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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.
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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.
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- Radiographic [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]Coronal and Sagittal views of the spine
- Clinical outcomes [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]physical examination/pain scale
- 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)

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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 |
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

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
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 |
Principal Investigator: | Shay Bess, MD | Denver International Spine Center |
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: | February 3, 2021 |
Last Verified: | February 2021 |
scoliosis kyphosis treatment outcomes spinal deformity |
Congenital Abnormalities |