RECRUITING

Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

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Conditions

Cervical DeformityKyphosisScoliosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

Official Title

Prospective Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

Quick Facts

Study Start:2019-08-01
Study Completion:2033-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04194996

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years old at time of treatment
  2. * Diagnosis of cervical deformity- must meet one or more of the following criteria:
  3. * C2-C7 sagittal kyphosis (Cobb \> 15 degrees)
  4. * T1S-CL \> 35o
  5. * Segmental cervical kyphosis \> 10 degrees between any 2 vertebra between C2-T1 or \> 15 degrees across any 3 vertebra between C2-T1
  6. * Cervical scoliosis \> 10 degrees (Cobb angle must include end vertebra within the cervical spine)
  7. * C2-C7 SVA \> 4cm
  8. * McGregor's slope \> 20 degrees or CBVA \> 25 degrees
  9. * Plan for surgical correction of cervical deformity in the next 6 months
  10. * Willing to provide consent and complete study forms at baseline and follow-up intervals
  1. * Active spine tumor or infection
  2. * Deformity due to acute trauma
  3. * Unwilling to provide consent or to complete study forms
  4. * Prisoner
  5. * Pregnant or immediate plans to get pregnant

Contacts and Locations

Study Contact

Christine Baldus, MS
CONTACT
6184444130
baldusc@wustl.edu
Ray Pinteric
CONTACT
ray.pinteric@outlook.com

Principal Investigator

Justin Smith, MD
PRINCIPAL_INVESTIGATOR
University of Virginia, Department of Neurosurgery
Christopher Ames, MD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco, Department on Neurosurgery
Christopher I Shaffrey, MD
PRINCIPAL_INVESTIGATOR
Duke University, Departments of Neurosurgery and Orthopaedic Surgery

Study Locations (Sites)

Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, 92037
United States
University of California Davis, Department of Orthopedic Surgery
Sacramento, California, 95817
United States
University of California-San Francisco Medical Center
San Francisco, California, 94143
United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80128
United States
Rush University, Department of Neurosurgery
Chicago, Illinois, 60612
United States
University of Kansas Medical Center, Department of Orthopedic Surgery
Kansas City, Kansas, 66160
United States
Leatherman Spine Center, Department of Orthopedic Surgery
Louisville, Kentucky, 40202
United States
Johns Hopkins University, Department of Neurological Surgery
Baltimore, Maryland, 21224
United States
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, 48109
United States
Washington University, Department of Orthopedic Surgery
Saint Louis, Missouri, 63110
United States
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New York, 10003
United States
New York University, Department of Orthopedic Surgery
New York, New York, 10003
United States
Columbia University Medical Center
New York, New York, 10032
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
United States
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texas, 75243
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: International Spine Study Group Foundation

  • Justin Smith, MD, PRINCIPAL_INVESTIGATOR, University of Virginia, Department of Neurosurgery
  • Christopher Ames, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco, Department on Neurosurgery
  • Christopher I Shaffrey, MD, PRINCIPAL_INVESTIGATOR, Duke University, Departments of Neurosurgery and Orthopaedic Surgery

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 Registration Dates

Study Start Date2019-08-01
Study Completion Date2033-07-31

Study Record Updates

Study Start Date2019-08-01
Study Completion Date2033-07-31

Terms related to this study

Keywords Provided by Researchers

  • Cervical deformity
  • Kyphosis
  • Scoliosis

Additional Relevant MeSH Terms

  • Cervical Deformity