NCT04885244 · International Spine Study Group Foundation
Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery
(MIS)
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- \>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
- 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
Exclusion criteria
- Deformity due to acute trauma
- Active spine tumor or infection
- Patient is unwilling or unable to complete questionnaires
- Women who are pregnant
- Open Posterior spinal fusion is planned (Open Anterior, i.e. ALIF, is acceptable)
Where
- Phoenix, Arizona
- La Jolla, California
- Los Angeles, California
- San Francisco, California
- Miami, Florida
- Chicago, Illinois
- Shreveport, Louisiana
- Ann Arbor, Michigan
- New York, New York
- Durham, North Carolina
- Pittsburgh, Pennsylvania
- Memphis, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations