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Complex Adult Deformity Surgery (CADS)
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 patientsAbout 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
- Index or spine revision surgery for complex adult spinal deformity (procedure)
Sponsor: International Spine Study Group Foundation · Participants: 1,500 · Started: Jul 30, 2018
Contact the study team
- Christine Baldus, MS · Phone: 618-444-4130
Official record on ClinicalTrials.gov — NCT04194138
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.