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Complex Adult Deformity Surgery (CADS)

Recruitingn/aAges 18 Years - anyAllInternational Spine Study Group Foundation
NCT04194138 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Index or spine revision surgery for complex adult spinal deformity
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Where

18 sites
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, United States
University of California, Davis, Department of Orthopedic Surgery
Sacramento, United States
UCSF, Department of Neurosurgery
San Francisco, United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, United States
University of Kansas, Department of Orthopedic Surgery
Kansas City, United States
Norton Leatherman Spine Center
Louisville, United States
Spine Institute of Louisiana
Shreveport, United States
John Hopkins University, Department of Orthopedic Surgery
Baltimore, United States

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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