- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588054
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity (PCD)
October 11, 2023 updated by: International Spine Study Group Foundation
Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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La Jolla, California, United States, 92037
- Scripps Clinic La Jolla
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Sacramento, California, United States, 95817
- University of California - Davis
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San Francisco, California, United States, 94143
- University of California - San Francisco Medical Center
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Colorado
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Denver, Colorado, United States, 80128
- Denver International Spine Center
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
-
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New York
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New York, New York, United States, 10021
- Hospital for Special Surgery
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New York, New York, United States, 10003
- New York University - Hospital for Joint Diseases
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Texas
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Plano, Texas, United States, 75093
- Baylor Scoliosis Center
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
spine surgeon clinic
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiographs
Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
|
Changes in the degree of deformity post surgical correction and assessment of fusion.
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Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Changes related to worsening/improved neck pain as regards ability to manage everyday life.
|
Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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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
|
Changes in level of neck and back pain within the past month
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Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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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
|
Changes with swallowing problems affecting day-to-day quality of life
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Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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EQ-5D3L
Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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Changes in current health state
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Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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mJOA
Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
|
Changes in neck pain regarding ability fo function in everyday life
|
Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Justin Smith, MD, PhD
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 9, 2013
Primary Completion (Actual)
May 8, 2021
Study Completion (Actual)
June 1, 2021
Study Registration Dates
First Submitted
April 24, 2012
First Submitted That Met QC Criteria
April 26, 2012
First Posted (Estimated)
April 30, 2012
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2107-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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