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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
Shay Bess, International Spine Study Group Foundation
ClinicalTrials.gov Identifier:
NCT00738439
First received: August 18, 2008
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition
Spinal Deformity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:


Further study details as provided by International Spine Study Group Foundation:

Primary Outcome Measures:
  • Radiographic [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ] [ Designated as safety issue: Yes ]
    Coronal and Sagittal views of the spine


Secondary Outcome Measures:
  • Clinical outcomes [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ] [ Designated as safety issue: No ]
    physical examination/pain scale

  • Health related quality of life [ Time Frame: initial visit, 1 year, 2 years, 3-5 years ] [ Designated as safety issue: No ]
    Oswestry, SRS22r, SF-36, LSDI DRAM (optional)


Estimated Enrollment: 936
Study Start Date: October 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
San Diego Center for Spinal Disorders
La Jolla, California, United States, 92037
University of California - Davis
Sacramento, California, United States, 95817
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Colorado
Rocky Mountain Scoliosis & Spine/PSL
Denver, Colorado, United States, 80218
United States, Kansas
Doug Burton, MD
Kansas City, Kansas, United States, 66160-7387
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287-0882
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
NYU Hospital for Joint Diseases
New York, New York, United States, 10010
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Texas
Baylor Scoliosis Center
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Shay Bess
DePuy Spine
Investigators
Principal Investigator: Shay Bess, MD Rocky Mountain Scoliosis and Spine
  More Information

No publications provided

Responsible Party: Shay Bess, President, ISSGF, International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT00738439     History of Changes
Other Study ID Numbers: 1-08-1850
Study First Received: August 18, 2008
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by International Spine Study Group Foundation:
scoliosis
kyphosis
treatment outcomes
spinal deformity

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on September 16, 2014