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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 18, 2008

Last Updated Date

September 15, 2008

Start Date ^†

October 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00738439 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Study Type ^†

Observational

Study Design ^†

Case Control, Prospective

Condition ^†

Spinal Deformity

Intervention ^†

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Not yet recruiting

Enrollment ^†

936

Estimated Completion Date

December 2012

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Raymarla J Pinteric

303.637.9914

raypinteric@q.com

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00738439

Responsible Party

Shay Bess, MD / Director of International Spine Study Group, Children's Specialists Foundation

Secondary IDs ^††

Study Sponsor ^†

Children's Specialists Foundation

Collaborators ^††

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

Information Provided By

Children's Specialists Foundation

Verification Date

September 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.