Complex Adult Deformity Surgery (CADS)
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
| Condition(s) | Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | International Spine Study Group Foundation |
| Locations | La Jolla, California, United States; Sacramento, California, United States; San Francisco, California, United States; Denver, Colorado, United States; Kansas City, Kansas, United States; Louisville, Kentucky, United States (+12 more sites) |
| Start date | 2018-07-30 |
| NCT ID | NCT04194138 |
| Official listing | https://clinicaltrials.gov/study/NCT04194138 |