Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
Recruiting now
Conditions studied: Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance
In brief
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.
Key facts
- Study ID
- NCT04885244
- Run by
- International Spine Study Group Foundation
- People needed
- 500
- Starts
- 2021-07-28
- Expected to finish
- 2034-12-31
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- >18 years of age at the time of treatment
- Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory or iatrogenic spinal deformity
- EOS full body or standing 36" AP \& Lateral images of entire spine
- Surgery to be schedule to take place within 6 months (otherwise PROMs/Radiographic images to be recollected)
- AND Either:
- One of the following Radiographic criteria:
- PI-LL ≥ 25 degrees
- Thoracolumbar/lumbar scoliosis ≥ 20 degrees
- SVA >10cm
- PT > 30 OR
- One of the Following Procedural criteria:
- 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)
- Posterior UIV and LIV must be placed percutaneously
- Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not)
- Staged ≥ 3 levels fused with percutaneous pedicle screws
- 3 column osteotomy with percutaneous fixation
- ACR incorporating open or percutaneous fixation as long as UIV and LIV are percutaneous screws
You may not qualify if…
- Deformity due to acute trauma
- Active spine tumor or infection
- Patient is unwilling or unable to complete questionnaires
- Women who are pregnant
- Prisoners
- Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)
Where it is running
- Semmes-Murphey — Memphis, Tennessee, United States (enrolling)
- Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (enrolling)
- Cedars-Sinai Medical Center — Los Angeles, California, United States (enrolling)
- University of California - San Francisco Medical Center — San Francisco, California, United States (enrolling)
- University of Miami — Miami, Florida, United States (enrolling)
- Rush University, Department of Neurosurgery — Chicago, Illinois, United States (enrolling)
- Louisiana Spine Institute — Shreveport, Louisiana, United States (enrolling)
- Barrow Neurological Institute — Phoenix, Arizona, United States (enrolling)
- Columbia University - New York-Presbyterian Och Spine Hospital — New York, New York, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- University of Michigan, Department of Neurosurgery — Ann Arbor, Michigan, United States
Full record on ClinicalTrials.gov
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