Evaluating outcomes of surgery for complex adult spinal deformities
Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery
International Spine Study Group Foundation · NCT04194138
This study looks at how well surgery works for adults with complex spinal deformities like scoliosis and kyphosis to see if it can improve their health and reduce complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Spine Study Group Foundation (other) |
| Locations | 18 sites (La Jolla, California and 17 other locations) |
| Trial ID | NCT04194138 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with complex spinal deformities who meet specific radiographic and procedural criteria.
Not a fit: Patients under 18 years of age or those with active spine tumors, infections, or neuromuscular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients undergoing surgery for complex spinal deformities.
How similar studies have performed: Other studies have shown success in evaluating surgical outcomes for spinal deformities, but this study aims to establish a more standardized approach, making it a novel contribution.
Eligibility criteria
Show full inclusion / exclusion 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 patients
Where this trial is running
La Jolla, California and 17 other locations
- Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (RECRUITING)
- University of California, Davis, Department of Orthopedic Surgery — Sacramento, California, United States (ACTIVE_NOT_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)
- John Hopkins University, Department of Orthopedic Surgery — Baltimore, Maryland, United States (RECRUITING)
- NYU, Department of Orthopedics — New York, New York, United States (RECRUITING)
- Hospital for Special Surgery, Department of Orthopedic Surgery — New York, New York, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
- Northwell Health — New York, New York, United States (RECRUITING)
- Duke University Health System — Durham, North Carolina, United States (RECRUITING)
- University Orthopedics — Providence, Rhode Island, United States (RECRUITING)
- Medical City Spine Hospital - Southwest Scoliosis Institute — Dallas, Texas, United States (RECRUITING)
- University of Texas - Houston — Houston, Texas, United States (RECRUITING)
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
- Toronto Western — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Shay Bess, MD
- Study coordinator: Christine Baldus, MS
- Email: baldusc@wustl.edu
- Phone: 618-444-4130
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance, Spinal deformity