NCT00738439Active, not recruitingNot Applicable
Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Shay Bess9 sites in 1 country1,999 target enrollmentStarted: October 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 1,999
- Locations
- 9
- Primary Endpoint
- Radiographic
Study Overview
Brief Summary
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Radiographic
Time Frame: initial visit, 1 year, 2 years, 3-5 years
Coronal and Sagittal views of the spine
Secondary Outcomes
- Clinical outcomes(initial visit, 1 year, 2 years, 3-5 years)
- Health related quality of life(initial visit, 1 year, 2 years, 3-5 years)
Investigators
Shay Bess
President, ISSGF
International Spine Study Group Foundation
Study Sites (9)
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