Multi-Center Prospective Evaluation of Operative Versus Nonoperative Treatment for Adult Spinal Deformity - Full Text View

Purpose

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

Condition

Spinal Deformity

MedlinePlus related topics:

Scoliosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective

Official Title:	Multi-Center Prospective Evaluation of Operative Versus Nonoperative Treatment for Adult Spinal Deformity: Differentiating Clinical and Radiographic Features and Evaluation of Treatment Outcomes

Further study details as provided by Children's Specialists Foundation:

Primary Outcome Measures:

Radiographic [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical outcomes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Health related quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	936
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2012

Groups/Cohorts

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738439

Contacts


Contact: Raymarla J Pinteric	303.637.9914	raypinteric@q.com

Locations


United States, California
	San Diego Center for Spinal Disorders	Not yet recruiting
	La Jolla, California, United States, 92037
	Contact: Pooria Salari 858-678-0610 psalaria@sandiego-spine.com
	Principal Investigator: Behrooz Akbarnia, MD
	University of California - Davis	Not yet recruiting
	Sacramento, California, United States, 95817
	Contact: Noelle Nord 916-734-6291 noelle.nord@ucdmc.ucdavis.edu
	Principal Investigator: Munish Gupta, MD

United States, Colorado
	Colorado Spine and Scoliosis Center	Not yet recruiting
	Lone Tree, Colorado, United States, 80124
	Contact: Breton Line 303-788-5230 breton.line@gmail.com
	Principal Investigator: Shay Bess, MD

United States, Florida
	Miami Children's Hospital	Not yet recruiting
	Miami, Florida, United States, 33155-3009
	Contact: Dianna Morales 786-624-2833 lanningk@ohsu.edu
	Principal Investigator: Michael O'Brien, MD

United States, Kansas
	Doug Burton, MD	Not yet recruiting
	Kansas City, Kansas, United States, 66160-7387
	Contact: Mariam Riaz-Kermani 913-588-0581 mriazikermani@kumc.edu
	Principal Investigator: Doug Burton, MD

United States, Massachusetts
	Massachusetts General Hospital	Not yet recruiting
	Boston, Massachusetts, United States, 02114
	Contact: David Shervin 617-724-1509 dshervin@partners.org
	Principal Investigator: Kirkham Wood, MD

United States, New York
	NYU Hospital for Joint Diseases	Not yet recruiting
	New York, New York, United States, 10010
	Contact: Virginie Lafage 212-598-6763 virginie.lafage@gmail.com
	Principal Investigator: Frank Schwab, MD
	Hospital for Special Surgery	Not yet recruiting
	New York, New York, United States, 10021
	Contact: Dana Krozek 212-606-1929
	Principal Investigator: Oheneba Boachie-Adjei, MD
	Sub-Investigator: Matthew Cunningham, MD

United States, Oregon
	Oregon Health Sciences University	Not yet recruiting
	Portland, Oregon, United States, 97239
	Contact: Kara Lanning 503-494-5038 lanningk@ohsu.edu
	Principal Investigator: Robert Hart, MD

United States, Texas
	Baylor Scoliosis Center
	Plano, Texas, United States, 75093
	Contact: Chantelle Freeman 972-985-2797 chantelf@baylorhealth.edu
	Sub-Investigator: Richard Hostin, MD

United States, Virginia
	University of Virginia	Not yet recruiting
	charlottesville, Virginia, United States, 22908
	Contact: Daniel Chernawsky, MD 434-243-9986 drc2v@virginia.edu
	Principal Investigator: Christopher Shaffrey, MD

Sponsors and Collaborators

Children's Specialists Foundation

DePuy Spine

Investigators


Principal Investigator:	Oheneba Boachie-Adjei, MD	Hospital for Special Surgery - NY, NY

Study Director:	Shay Bess, MD	Colorado Spine and Scoliosis Institute, Lone Tree, CO

Study Chair:	Raymarlra Pinteric, AAS	International Spine Study Group

More Information

Responsible Party:	Children's Specialists Foundation ( Shay Bess, MD / Director of International Spine Study Group )
Study ID Numbers:	1-08-1850
First Received:	August 18, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00738439
Health Authority:	United States: Institutional Review Board

Keywords provided by Children's Specialists Foundation:

scoliosis

kyphosis

treatment outcomes

spinal deformity

Study placed in the following topic categories:

Scoliosis

Kyphosis

Congenital Abnormalities

ClinicalTrials.gov processed this record on October 15, 2008

Sponsors and Collaborators:	Children's Specialists Foundation DePuy Spine
Information provided by:	Children's Specialists Foundation
ClinicalTrials.gov Identifier:	NCT00738439