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Search / Trial NCT04194138

Complex Adult Deformity Surgery (CADS)

Launched by INTERNATIONAL SPINE STUDY GROUP FOUNDATION · Dec 10, 2019

Trial Information

Current as of July 24, 2025

Recruiting

Keywords

Scoliosis Kyphosis Sagittal Imbalance Spinal Deformity

ClinConnect Summary

The Complex Adult Deformity Surgery (CADS) trial is studying the outcomes of surgical treatments for adults with spinal deformities, such as scoliosis and kyphosis. The goal is to find the best practices for surgery, including how well patients recover and any complications that may arise after surgery. Researchers want to understand what factors might affect the success of the surgery and how to improve patient care to minimize risks and enhance recovery.

To be eligible for this trial, participants should be adults aged 65 and older who have specific types of spinal deformities, including congenital, degenerative, or idiopathic conditions. They must also have a detailed body scan (called EOS radiography) to assess their spine. However, individuals with certain conditions like active tumors, infections, or serious neurological diseases cannot participate. If you join the trial, you can expect thorough evaluations and close monitoring throughout the surgical process and recovery to help improve future treatments for others with similar conditions.

Gender

ALL

Eligibility criteria

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

About International Spine Study Group Foundation

The International Spine Study Group Foundation (ISSGF) is a leading organization dedicated to advancing research and clinical practices in spine surgery and care. Comprising a network of experts in the field, the foundation focuses on facilitating high-quality, multi-center clinical trials aimed at improving patient outcomes and enhancing the understanding of spinal disorders. Through collaboration with healthcare professionals, academic institutions, and industry partners, the ISSGF promotes evidence-based approaches to spine treatment, aiming to establish best practices and develop innovative solutions for complex spinal conditions.

Locations

New York, New York, United States

Houston, Texas, United States

Durham, North Carolina, United States

Charlottesville, Virginia, United States

Shreveport, Louisiana, United States

Providence, Rhode Island, United States

Louisville, Kentucky, United States

La Jolla, California, United States

Toronto, Ontario, Canada

New York, New York, United States

Sacramento, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Kansas City, Kansas, United States

Baltimore, Maryland, United States

Saint Louis, Missouri, United States

New York, New York, United States

New York, New York, United States

Dallas, Texas, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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