NCT04194138 · International Spine Study Group Foundation
Complex Adult Deformity Surgery (CADS)
(CADS)
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion 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
- 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
Exclusion criteria
- 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)
- Women who are pregnant
- Non English speaking patients
Where
- La Jolla, California
- Sacramento, California
- San Francisco, California
- Denver, Colorado
- Kansas City, Kansas
- Louisville, Kentucky
- Shreveport, Louisiana
- Baltimore, Maryland
- New York, New York
- Durham, North Carolina
- Providence, Rhode Island
- Dallas, Texas
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations