Status:
ACTIVE_NOT_RECRUITING
Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Lead Sponsor:
Shay Bess
Collaborating Sponsors:
DePuy Spine
K2M, Inc.
Conditions:
Spinal Deformity
Eligibility:
All Genders
18+ years
Brief Summary
The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.
Eligibility Criteria
Inclusion
- 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
- Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
- Age \<18 yrs at time of surgery or initial consultation
Key Trial Info
Start Date :
October 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2025
Estimated Enrollment :
1999 Patients enrolled
Trial Details
Trial ID
NCT00738439
Start Date
October 1 2008
End Date
September 1 2025
Last Update
March 5 2024
Active Locations (9)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
University of California - Davis
Sacramento, California, United States, 95817
3
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143
4
Denver International Spine Center
Denver, Colorado, United States, 80218