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

Launched by INTERNATIONAL SPINE STUDY GROUP FOUNDATION · May 10, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how effective minimally invasive surgery is for adults with complex spinal deformities, such as scoliosis and kyphosis. The goal is to understand the outcomes of this type of surgery, including how well patients recover, any complications that might happen, and what factors could affect the success of the surgery. Researchers are also interested in finding the best practices that can help improve patient care and reduce problems after surgery.

To be eligible for this study, participants must be adults over 18 years old with specific types of spinal deformities. They should be scheduled for surgery within the next six months and must meet certain criteria based on their spinal condition. If you join the trial, you will undergo a minimally invasive surgical procedure and will be asked to complete some questionnaires about your experience and recovery. It’s important to note that this trial is currently recruiting participants, and it welcomes individuals of all genders.

Gender

ALL

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) 5. Surgery to include \> 3 levels percutaneous posterior spinal instrumentation or 3 level stand-alone lateral 6. And any one of the following:
• • a. Radiographic criteria incorporating percutaneous posterior spinal instrumentation: i. PI-LL ≥ 25 degrees ii. Thoracolumbar/lumbar scoliosis ≥ 20 degrees iii. SVA \>10cm iv. PT \> 30 b. Procedural criteria: i. Single-position surgery ≥ 3 levels fused (Levels=vertebra; S1 is counted as a level; S2 \&/or pelvis/ilium is not) ii. Staged ≥ 3 levels fused with percutaneous pedicle screws iii. 3 column osteotomy with percutaneous fixation iv. ACR incorporating open or percutaneous fixation
• 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 -