No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
1,500 (estimated)
Sponsor
International Spine Study Group Foundation · Other
Who this trial is looking for
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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.
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Eligibility 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…
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
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