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Multi-Center Prospective Evaluation of Operative Versus Nonoperative Treatment for Adult Spinal Deformity (PON)
This study is enrolling participants by invitation only.
Sponsor:
Shay Bess
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation
ClinicalTrials.gov Identifier:
NCT00738439
First received: August 18, 2008
Last updated: August 31, 2016
Last verified: August 2016
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Purpose
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.
| Condition |
|---|
| Spinal Deformity |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Multi-Center Prospective Evaluation of Operative Versus Nonoperative Treatment for Adult Spinal Deformity: Differentiating Clinical and Radiographic Features and Evaluation of Treatment Outcomes |
Further study details as provided by Shay Bess, International Spine Study Group Foundation:
Primary Outcome Measures:
- Radiographic [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ]Coronal and Sagittal views of the spine
Secondary Outcome Measures:
- 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)
| Estimated Enrollment: | 936 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | December 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
Eligibility| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738439
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738439
Locations
| United States, California | |
| San Diego Center for Spinal Disorders | |
| 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 | |
| Rocky Mountain Scoliosis & Spine/PSL | |
| 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, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| 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
Investigators
| Principal Investigator: | Shay Bess, MD | Rocky Mountain Scoliosis and Spine |
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 |
| Study First Received: | August 18, 2008 |
| Last Updated: | August 31, 2016 |
Keywords provided by Shay Bess, International Spine Study Group Foundation:
|
scoliosis kyphosis treatment outcomes spinal deformity |
Additional relevant MeSH terms:
|
Congenital Abnormalities |
ClinicalTrials.gov processed this record on September 21, 2017