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Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

Recruitingn/aAges 18 Years - anyAllInternational Spine Study Group Foundation
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In plain words

What the trial is, and whether it could suit you

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. \>18 years of age at the time of treatment 2. Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity 3. EOS full body or standing 36" AP \& Lateral images of entire spine 4. Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected) AND Either: 5. One of the following Radiographic criteria: 1. PI-LL ≥ 25 degrees 2. Thoracolumbar/lumbar scoliosis ≥ 20 degrees 3. SVA \>10cm 4. PT \> 30 OR 6. One of the Following Procedural criteria: 1. Surgery to include \> 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone interbody. (Levels = vertebra (i.e. percutaneous screws at L2, L3, L4 would be eligible for posterior instrumentation and/or L3-L4, L4-L5 would be eligible as stand-alone for interbodies) 2. Posterior UIV and LIV must be placed percutaneously 3. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) 4. Staged ≥ 3 levels fused with percutaneous pedicle screws 5. 3 column osteotomy with percutaneous fixation 6. ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws Exclusion Criteria: 1. Deformity due to acute trauma 2. Active spine tumor or infection 3. Patient is unwilling or unable to complete questionnaires 4. Women who are pregnant 5. Prisoners 6. Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)
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What it tests

  • Index or spine revision surgery for complex adult spinal deformity
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Where

12 sites
Barrow Neurological Institute
Phoenix, United States
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, United States
Cedars-Sinai Medical Center
Los Angeles, United States
University of California - San Francisco Medical Center
San Francisco, United States
University of Miami
Miami, United States
Rush University, Department of Neurosurgery
Chicago, United States
Louisiana Spine Institute
Shreveport, United States
University of Michigan, Department of Neurosurgery
Ann Arbor, United States

…and 4 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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