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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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