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Complex Adult Deformity Surgery (CADS)

RecruitingObservational study

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Who can join

Ages 18 and older · All sexes

Full 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 the study

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.

What is being tested

Sponsor: International Spine Study Group Foundation · Participants: 1,500 · Started: Jul 30, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT04194138

Locations in the U.S.

CaliforniaShiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla
UCSF, Department of Neurosurgery, San Francisco
ColoradoDenver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center, Denver
KansasUniversity of Kansas, Department of Orthopedic Surgery, Kansas City
KentuckyNorton Leatherman Spine Center, Louisville
LouisianaSpine Institute of Louisiana, Shreveport
MarylandJohn Hopkins University, Department of Orthopedic Surgery, Baltimore
New YorkColumbia University Medical Center, New York
Hospital for Special Surgery, Department of Orthopedic Surgery, New York
NYU, Department of Orthopedics, New York
Northwell Health, New York
North CarolinaDuke University Health System, Durham
Rhode IslandUniversity Orthopedics, Providence
TexasMedical City Spine Hospital - Southwest Scoliosis Institute, Dallas
University of Texas - Houston, Houston
VirginiaUniversity of Virginia, Charlottesville

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.