Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry

NCT00738439 | Active Not Recruiting

• 1 other identifier: 1-08-1850
• Study Type: observational
• Target: 1,999
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Spinal Deformity

Keywords

scoliosis; kyphosis; treatment outcomes; spinal deformity

Outcome Measures

Primary Outcomes (1)

• Radiographic

  Coronal and Sagittal views of the spine

  initial visit, 1 year, 2 years, 3-5 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Operative

Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees requiring surgery.

Nonoperative

Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees not requiring surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients greater than 18 years of age who meet inclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
• Age \<18 yrs at time of surgery or initial consultation

Sponsors & Collaborators

• NuVasive: collaborator
• International Spine Study Group Foundation: lead

Study Sites (9)

Scripps Clinic

La Jolla, California, 92037, United States

Location

University of California - Davis

Sacramento, California, 95817, United States

Location

University of California - San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Denver International Spine Center

Denver, Colorado, 80218, United States

Location

Doug Burton, MD

Kansas City, Kansas, 66160-7387, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287-0882, United States

Location

NYU Hospital for Joint Diseases

New York, New York, 10010, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• Passias PG, Soroceanu A, Scheer J, Yang S, Boniello A, Smith JS, Protopsaltis T, Kim HJ, Schwab F, Gupta M, Klineberg E, Mundis G, Lafage R, Hart R, Shaffrey C, Lafage V, Ames C; International Spine Study Group. Magnitude of preoperative cervical lordotic compensation and C2-T3 angle are correlated to increased risk of postoperative sagittal spinal pelvic malalignment in adult thoracolumbar deformity patients at 2-year follow-up. Spine J. 2015 Aug 1;15(8):1756-63. doi: 10.1016/j.spinee.2015.04.007. Epub 2015 Apr 8.

  PMID: 25862507 DERIVED

MeSH Terms

Conditions

Scoliosis; Kyphosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Shay Bess, MD

  Denver International Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2008
• First Posted: August 20, 2008
• Study Start: October 1, 2008
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Locations

US (9)