Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity (PCD)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
International Spine Study Group Foundation
ClinicalTrials.gov Identifier:
NCT01588054
First received: April 24, 2012
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to define clinical and demographic features within the population suffering from cervical deformity to assist health professionals to make important treatment decisions.


Condition
Cervical Deformity
Kyphosis
Scoliosis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Radiographs [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes in the degree of deformity post surgical correction and assessment of fusion.


Secondary Outcome Measures:
  • Neck Disability Index (NDI) [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes related to worsening/improved neck pain as regards ability to manage everyday life.

  • Numeric rating scale (NRS) [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes in level of neck and back pain within the past month

  • CSRS SWAL-QOL [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes with swallowing problems affecting day-to-day quality of life

  • EQ-5D3L [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes in current health state

  • mJOA [ Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop ] [ Designated as safety issue: No ]
    Changes in neck pain regarding ability fo function in everyday life


Enrollment: 100
Study Start Date: April 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
adults, cervical deformity, surgical treatment
Adults 18years or older at time of enrollment, cervical deformity to include kyphosis (C2-7 greater than 10 degrees) or scoliosis (coronal cobb greater than 10 degrees), plans for surgical treatment of cervical deformity

  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

spine surgeon clinic

Criteria

Inclusion Criteria:

  • Adult 18 years of age or greater
  • Cervical deformity (kyphosis C2-7 greater than 10 degrees or scoliosis with coronal cobb greater than 10 degrees)
  • Plans for surgical correction of cervical deformity

Exclusion Criteria:

  • Active tumor or infection
  • Acute trauma
  • Unwillingness to provide consent or complete study forms
  • Prisoner
  • Pregnant or planning to get pregnant during study period
  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: NCT01588054

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 and Spine
Denver, Colorado, United States, 80205
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University
St Louis, Missouri, United States, 63110
United States, New York
New York University - Hospital for Joint Diseases
New York, New York, United States, 10003
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Baylor Scoliosis Center
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Canada, Ontario
University of Toronto
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
International Spine Study Group Foundation
DePuy Spine
Investigators
Principal Investigator: Justin Smith, MD, PhD
  More Information

No publications provided

Responsible Party: International Spine Study Group Foundation
ClinicalTrials.gov Identifier: NCT01588054     History of Changes
Other Study ID Numbers: 2107-01
Study First Received: April 24, 2012
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Kyphosis
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 29, 2014