Actively Recruiting
Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)
Led by International Spine Study Group Foundation · Updated on 2026-02-17
500
Participants Needed
12
Research Sites
N/A
Total Duration
On this page
Sponsors
I
International Spine Study Group Foundation
Lead Sponsor
N
NuVasive
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate surgical outcomes and develop best practice guidelines for adults with complex spinal deformities treated using minimally invasive surgery. The study focuses on various spinal deformities including congenital, degenerative, idiopathic, neuromuscular, inflammatory, or iatrogenic causes. It assesses radiographic and clinical outcomes, surgical complications, risk factors, revision surgery rates, and the impact of standardized procedures on improving patient results and reducing complications. Participants will undergo minimally invasive surgical procedures involving percutaneous posterior spinal instrumentation or stand-alone lateral surgery across three or more spinal levels. The study also examines the use of robotic techniques, expandable cages, single-position versus multi-position surgery, and perioperative blood management strategies. Evaluation includes the entire episode of care, including prehabilitation, pain management, and mental health support to enhance outcomes and reduce hospital stays and costs. During the study, participants will be followed up at multiple time points including 3 months, and 1, 2, 5, and 10 years after surgery. Assessments include patient-reported outcome measures such as the Scoliosis Research Society 22r, Oswestry Disability Index, Veterans RAND-12, and PROMIS scales covering anxiety, depression, pain, physical function, and social satisfaction. Radiographic evaluations and pain scales for back and leg pain are also collected. Safety monitoring includes tracking adverse events, frailty assessments, and mental and social health evaluations throughout the follow-up period.
CONDITIONS
Brief Title
Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be older than 18 years at the time of treatment
- Diagnosis of adult congenital, degenerative, idiopathic, neuromuscular, inflammatory, or iatrogenic spinal deformity
- Must have full body or standing spine images (EOS full body or standing 36" AP & Lateral images)
- Surgery must be scheduled within 6 months; if not, patient-reported outcomes and images must be recollected
- Must meet at least one radiographic criterion: PI-LL ≥ 25 degrees, thoracolumbar/lumbar scoliosis ≥ 20 degrees, SVA >10cm, or PT > 30
- OR meet at least one procedural criterion: surgery includes 3 or more levels of percutaneous posterior spinal instrumentation or 3 level stand-alone interbody, posterior UIV and LIV placed percutaneously, single-position surgery with 3 or more levels fused, staged surgery with 3 or more levels fused using percutaneous pedicle screws, 3 column osteotomy with percutaneous fixation, or anterior column realignment with percutaneous fixation as long as UIV and LIV are percutaneous screws
You will not qualify if you...
- Deformity due to acute trauma
- Active spine tumor or infection
- Unable or unwilling to complete questionnaires
- Women who are pregnant
- Prisoners
- Planned open posterior spinal fusion (open anterior fusion is acceptable)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months from scheduling to surgery and immediate recovery
Participants undergo minimally invasive surgery for complex adult spinal deformity, including procedures such as percutaneous posterior spinal instrumentation or lateral surgery involving 3 or more levels.
1 surgical visit and inpatient post-operative care
Duration - Up to 10 years
Participants attend follow-up visits to assess clinical and radiographic outcomes, complications, and patient-reported measures over time after surgery.
Visits at 3 months, 1 year, 2 years, 5 years, and 10 years post-surgery
Trial Site Locations
Total: 12 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
Actively Recruiting
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
4
University of California - San Francisco Medical Center
San Francisco, California, United States, 94143
Actively Recruiting
5
University of Miami
Miami, Florida, United States, 33125
Actively Recruiting
6
Rush University, Department of Neurosurgery
Chicago, Illinois, United States, 60612
Actively Recruiting
7
Louisiana Spine Institute
Shreveport, Louisiana, United States, 71101
Actively Recruiting
8
University of Michigan, Department of Neurosurgery
Ann Arbor, Michigan, United States, 48109
Completed
9
Columbia University - New York-Presbyterian Och Spine Hospital
New York, New York, United States, 10034
Actively Recruiting
10
Duke University Health System
Durham, North Carolina, United States, 27710
Actively Recruiting
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
12
Semmes-Murphey
Memphis, Tennessee, United States, 38120
Actively Recruiting
Research Team
C
Christine Baldus, MS
R
Ray Pinteric
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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