Complex Adult Deformity Surgery (CADS)
Recruiting now
Conditions studied: Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance
In brief
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.
Key facts
- Study ID
- NCT04194138
- Run by
- International Spine Study Group Foundation
- People needed
- 1500
- Starts
- 2018-07-30
- Expected to finish
- 2032-07-31
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
- Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
- Complex patients are defined as and meeting any one of the subsequent criteria:
- Radiographic criteria:
- PI-LL ≥ 25 degrees
- TPA ≥ 30 degrees
- SVA>15cm
- Thoracic scoliosis ≥ 70 degrees
- Thoracolumbar/lumbar scoliosis ≥ 50 degrees
- Global coronal malalignment >7cm
- Procedural criteria:
- Posterior spinal fusion > 12 levels
- 3 column osteotomy or ACR
- Geriatric criteria:
- Age >65 years and minimum 7 levels of spinal instrumentation during surgery
You may not qualify if…
- Age <18 years of age
- Active spine tumor or infection
- Deformity due to acute trauma
- Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
- Syndromic scoliosis
- Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
- Prisoners
- Women who are pregnant
- Non English speaking patients
Where it is running
- Toronto Western — Toronto, Ontario, Canada (enrolling)
- Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (enrolling)
- UCSF, Department of Neurosurgery — San Francisco, California, United States (enrolling)
- Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center — Denver, Colorado, United States (enrolling)
- University of Kansas, Department of Orthopedic Surgery — Kansas City, Kansas, United States (enrolling)
- Norton Leatherman Spine Center — Louisville, Kentucky, United States (enrolling)
- Spine Institute of Louisiana — Shreveport, Louisiana, United States (enrolling)
- John Hopkins University, Department of Orthopedic Surgery — Baltimore, Maryland, United States (enrolling)
- NYU, Department of Orthopedics — New York, New York, United States (enrolling)
- Hospital for Special Surgery, Department of Orthopedic Surgery — New York, New York, United States (enrolling)
- Columbia University Medical Center — New York, New York, United States (enrolling)
- Northwell Health — New York, New York, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- University Orthopedics — Providence, Rhode Island, United States (enrolling)
- Medical City Spine Hospital - Southwest Scoliosis Institute — Dallas, Texas, United States (enrolling)
- University of Texas - Houston — Houston, Texas, United States (enrolling)
- University of Virginia — Charlottesville, Virginia, United States (enrolling)
- University of California, Davis, Department of Orthopedic Surgery — Sacramento, California, United States
Full record on ClinicalTrials.gov
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