RECRUITING

Complex Adult Deformity Surgery (CADS)

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Conditions

Adult Spinal DeformityScoliosisKyphosisSagittal ImbalanceSpinal deformity

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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

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative complications, risk factors for and revision surgery rates, and the role of standard work to improve patient outcomes and reduce surgical and postoperative complications.

Official Title

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Quick Facts

Study Start:2018-07-30
Study Completion:2032-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04194138

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. 1. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
  2. 2. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
  3. 3. Complex patients are defined as and meeting any one of the subsequent criteria:
  4. 1. Radiographic criteria:
  5. * PI-LL ≥ 25 degrees
  6. * TPA ≥ 30 degrees
  7. * SVA\>15cm
  8. * Thoracic scoliosis ≥ 70 degrees
  9. * Thoracolumbar/lumbar scoliosis ≥ 50 degrees
  10. * Global coronal malalignment \>7cm
  11. 2. Procedural criteria:
  12. * Posterior spinal fusion \> 12 levels
  13. * 3 column osteotomy or ACR
  14. 3. Geriatric criteria:
  15. * Age \>65 years and minimum 7 levels of spinal instrumentation during surgery
  1. 1. Age \<18 years of age
  2. 2. Active spine tumor or infection
  3. 3. Deformity due to acute trauma
  4. 4. Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
  5. 5. Syndromic scoliosis
  6. 6. Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
  7. 7. Prisoners
  8. 8. Women who are pregnant
  9. 9. Non English speaking patients

Contacts and Locations

Study Contact

Christine Baldus, MS
CONTACT
6184444130
baldusc@wustl.edu
Ray Pinteric
CONTACT
7209348014
ray.pinteric@outlook.com

Principal Investigator

Shay Bess, MD
PRINCIPAL_INVESTIGATOR
Denver International Spine Center
Lawrence Lenke, MD
PRINCIPAL_INVESTIGATOR
Columbia University, Department of Orthopedic Surgery
Christopher 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, 05616
United States
UCSF, Department of Neurosurgery
San Francisco, California, 94143
United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, 80218
United States
University of Kansas, Department of Orthopedic Surgery
Kansas City, Kansas, 66160
United States
Norton Leatherman Spine Center
Louisville, Kentucky, 40207
United States
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
United States
John Hopkins University, Department of Orthopedic Surgery
Baltimore, Maryland, 21224
United States
Washington University, Department of Orthopedic Surgery
Saint Louis, Missouri, 63310
United States
NYU, Department of Orthopedics
New York, New York, 10016
United States
Hospital for Special Surgery, Department of Orthopedic Surgery
New York, New York, 10021
United States
Columbia University Medical Center
New York, New York, 10032
United States
Northwell Health
New York, New York, 10075
United States
Duke University Health System
Durham, North Carolina, 27710
United States
University Orthopedics
Providence, Rhode Island, 02905
United States
Medical City Spine Hospital - Southwest Scoliosis Institute
Dallas, Texas, 75243
United States
University of Texas - Houston
Houston, Texas, 77030
United States
University of Virginia
Charlottesville, Virginia, 22908
United States

Collaborators and Investigators

Sponsor: International Spine Study Group Foundation

  • Shay Bess, MD, PRINCIPAL_INVESTIGATOR, Denver International Spine Center
  • Lawrence Lenke, MD, PRINCIPAL_INVESTIGATOR, Columbia University, Department of Orthopedic Surgery
  • Christopher 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 Date2018-07-30
Study Completion Date2032-07-31

Study Record Updates

Study Start Date2018-07-30
Study Completion Date2032-07-31

Terms related to this study

Keywords Provided by Researchers

  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance
  • Spinal deformity

Additional Relevant MeSH Terms

  • Adult Spinal Deformity
  • Scoliosis
  • Kyphosis
  • Sagittal Imbalance