MedPath

Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

Active, not recruiting
Conditions
Spinal Deformity
Registration Number
NCT00738439
Lead Sponsor
Shay Bess
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
1999
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Radiographicinitial visit, 1 year, 2 years, 3-5 years

Coronal and Sagittal views of the spine

Secondary Outcome Measures
NameTimeMethod
Clinical outcomesinitial visit, 1 year, 2 years, 3-5 years

physical examination/pain scale

Health related quality of lifeinitial visit, 1 year, 2 years, 3-5 years

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

Trial Locations

Locations (9)

Doug Burton, MD

🇺🇸

Kansas City, Kansas, United States

University of Virginia

🇺🇸

Charlottesville, Virginia, United States

University of California - Davis

🇺🇸

Sacramento, California, United States

Scripps Clinic

🇺🇸

La Jolla, California, United States

University of California - San Francisco Medical Center

🇺🇸

San Francisco, California, United States

Denver International Spine Center

🇺🇸

Denver, Colorado, United States

Johns Hopkins University

🇺🇸

Baltimore, Maryland, United States

NYU Hospital for Joint Diseases

🇺🇸

New York, New York, United States

Hospital for Special Surgery

🇺🇸

New York, New York, United States

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