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NCT00738439 Clinical Trial

Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

Spinal Deformity Clinical Trial

— PON  

Official title:
Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00738439
Other study ID # 1-08-1850
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2008
Est. completion date September 2025

Study information
Verified date March 2024
Source International Spine Study Group Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1999
Est. completion date September 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins University Baltimore Maryland
United States University of Virginia Charlottesville Virginia
United States Denver International Spine Center Denver Colorado
United States Doug Burton, MD Kansas City Kansas
United States Scripps Clinic La Jolla California
United States Hospital for Special Surgery New York New York
United States NYU Hospital for Joint Diseases New York New York
United States University of California - Davis Sacramento California
United States University of California - San Francisco Medical Center San Francisco California

Sponsors (6)
Lead Sponsor Collaborator
Shay Bess DePuy Spine, K2M, Inc., NuVasive, Orthofix Inc., Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Radiographic Coronal and Sagittal views of the spine initial visit, 1 year, 2 years, 3-5 years
Secondary Clinical outcomes physical examination/pain scale initial visit, 1 year, 2 years, 3-5 years
Secondary Health related quality of life Oswestry, SRS22r, SF-36, LSDI, EQ5D3L, NDI DRAM (optional) initial visit, 1 year, 2 years, 3-5 years
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