Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

N/AActive Not RecruitingNCT00738439

International Spine Study Group Foundation1,999 enrolled

Overview

The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

Study Type

OBSERVATIONAL

Enrollment

1,999

Conditions

Spinal Deformity

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Scripps Clinic

La Jolla, California, United States

University of California - Davis

Sacramento, California, United States

University of California - San Francisco Medical Center

San Francisco, California, United States

Outcomes

Primary Outcomes

Radiographic

Coronal and Sagittal views of the spine

Time frame: initial visit, 1 year, 2 years, 3-5 years

Secondary Outcomes

Clinical outcomes

physical examination/pain scale

Time frame: initial visit, 1 year, 2 years, 3-5 years

Health related quality of life

Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional)

Time frame: initial visit, 1 year, 2 years, 3-5 years

Data from ClinicalTrials.gov

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