Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity (PCD)
This study is enrolling participants by invitation only.
Sponsor:
International Spine Study Group Foundation
Collaborator:
DePuy Spine
Information provided by (Responsible Party):
International Spine Study Group Foundation
ClinicalTrials.gov Identifier:
NCT01588054
First received: April 24, 2012
Last updated: April 26, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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: | April 26, 2012 |
| 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 May 23, 2013