Evaluating outcomes of surgery for complex adult spinal deformities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the surgical treatment outcomes for patients with complex adult spinal deformities, including conditions like scoliosis and kyphosis. It will analyze both radiographic and clinical outcomes, assess surgical and postoperative complications, and identify risk factors for revision surgeries. The study will also develop a standardized classification system for complications and evaluate blood management approaches and pain management protocols to improve patient outcomes. By utilizing data from the ISSG database, the study seeks to establish best practice guidelines for managing complex adult spinal deformities.

Why it matters

Who can join: the full rules

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

Where it's running

• Shiley Center for Orthopaedic Research and Education at Scripps Clinic
  La Jolla, California, United States Recruiting
• UCSF, Department of Neurosurgery
  San Francisco, California, United States Recruiting
• Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
  Denver, Colorado, United States Recruiting
• University of Kansas, Department of Orthopedic Surgery
  Kansas City, Kansas, United States Recruiting
• Norton Leatherman Spine Center
  Louisville, Kentucky, United States Recruiting
• Spine Institute of Louisiana
  Shreveport, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Shay Bess, MD
• Study coordinator: Christine Baldus, MS
• Email: baldusc@wustl.edu
• Phone: 618-444-4130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.