Complex Adult Deformity Surgery (CADS)
Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
International Spine Study Group Foundation
1,500 participants
Jul 30, 2018
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria16
- Criteria:
- 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
- column osteotomy or ACR
- Geriatric criteria:
- Age \>65 years and minimum 7 levels of spinal instrumentation during surgery
Exclusion Criteria9
- 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
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Interventions
Surgical interventions will be patient specified by treating surgeon.
Locations(18)
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NCT04194138