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

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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)

About the study

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.

What is being tested

Sponsor: International Spine Study Group Foundation · Participants: 500 · Started: Jul 28, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04885244

Locations in the U.S.

ArizonaBarrow Neurological Institute, Phoenix
CaliforniaShiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla
Cedars-Sinai Medical Center, Los Angeles
University of California - San Francisco Medical Center, San Francisco
FloridaUniversity of Miami, Miami
IllinoisRush University, Department of Neurosurgery, Chicago
LouisianaLouisiana Spine Institute, Shreveport
New YorkColumbia University - New York-Presbyterian Och Spine Hospital, New York
North CarolinaDuke University Health System, Durham
PennsylvaniaUniversity of Pittsburgh Medical Center, Pittsburgh
TennesseeSemmes-Murphey, Memphis

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.