Clinical trial NCT00738439: Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Official title: Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spinal Deformity
Keywords: scoliosis
kyphosis
treatment outcomes
spinal deformity
Lead sponsor: International Spine Study Group Foundation
Sponsor class: OTHER
Collaborators: name: DePuy Spine
name: K2M, Inc.
name: NuVasive
name: Zimmer Biomet
name: Orthofix Inc.
First posted: 2008-08-20
Enrollment: 1999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients greater than 18 years of age who meet inclusion criteria.

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


Eligibility criteria: 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

Primary outcomes:
measure: Radiographic
timeFrame: initial visit, 1 year, 2 years, 3-5 years
Secondary outcomes:
measure: Clinical outcomes
timeFrame: initial visit, 1 year, 2 years, 3-5 years
measure: Health related quality of life
timeFrame: initial visit, 1 year, 2 years, 3-5 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Sacramento
country: United States
facility: University of California - Davis
state: California
city: San Francisco
country: United States
facility: University of California - San Francisco Medical Center
state: California
city: Denver
country: United States
facility: Denver International Spine Center
state: Colorado
city: Kansas City
country: United States
facility: Doug Burton, MD
state: Kansas
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: NYU Hospital for Joint Diseases
state: New York
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Denver International Spine Center
name: Shay Bess, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.