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

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

    • California
      • La Jolla, California, United States, 92037
        • Scripps Clinic La Jolla
      • Sacramento, California, United States, 95817
        • University of California - Davis
      • San Francisco, California, United States, 94143
        • University of California - San Francisco Medical Center
    • Colorado
      • Denver, Colorado, United States, 80128
        • Denver International Spine Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University
    • New York
      • New York, New York, United States, 10021
        • Hospital for Special Surgery
      • New York, New York, United States, 10003
        • New York University - Hospital for Joint Diseases
    • Texas
      • Plano, Texas, United States, 75093
        • Baylor Scoliosis Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia

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.
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
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
Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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
Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
EQ-5D3L
Time Frame: Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
Changes in current health state
Prior to surgery, 8-16 weeks postop, 4-8 months postop, 9-23 months postop, and 24-30 months postop
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

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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