Evaluating minimally invasive surgery for complex adult spinal deformities

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

This study is testing whether minimally invasive surgery can effectively treat complex spinal deformities in adults, like scoliosis and kyphosis, while also looking at costs and patient experiences.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: International Spine Study Group Foundation (other)
• Locations: 12 sites (Phoenix, Arizona and 11 other locations)
• Trial ID: NCT04885244 on ClinicalTrials.gov

What this trial studies

This study evaluates the outcomes of minimally invasive surgical treatments for complex adult spinal deformities, including conditions like scoliosis and kyphosis. It aims to identify best practice guidelines by analyzing clinical and radiographic outcomes, complications, and risk factors associated with surgery. The study will also develop a standardized classification system for complications and assess the cost-effectiveness of the surgical approach compared to traditional methods. Patient-reported outcomes will be measured to gauge the effectiveness of the interventions.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with specific spinal deformities requiring surgery involving multiple levels.

Not a fit: Patients with spinal deformities that do not meet the inclusion criteria or those not requiring surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with complex adult spinal deformities.

How similar studies have performed: Other studies have shown promising results with minimally invasive approaches for spinal deformities, suggesting potential for success in this study.

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)

Where this trial is running

Phoenix, Arizona and 11 other locations

• Barrow Neurological Institute — Phoenix, Arizona, United States (RECRUITING)
• Shiley Center for Orthopaedic Research and Education at Scripps Clinic — La Jolla, California, United States (RECRUITING)
• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)
• University of California - San Francisco Medical Center — San Francisco, California, United States (RECRUITING)
• University of Miami — Miami, Florida, United States (RECRUITING)
• Rush University, Department of Neurosurgery — Chicago, Illinois, United States (RECRUITING)
• Louisiana Spine Institute — Shreveport, Louisiana, United States (RECRUITING)
• University of Michigan, Department of Neurosurgery — Ann Arbor, Michigan, United States (COMPLETED)
• Columbia University - New York-Presbyterian Och Spine Hospital — New York, New York, United States (RECRUITING)
• Duke University Health System — Durham, North Carolina, United States (RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
• Semmes-Murphey — Memphis, Tennessee, United States (RECRUITING)

Study contacts

• Principal investigator: Praveen Mummaneni, MD — University of San Francisco
• Study coordinator: Christine Baldus, MS

Conditions: Adult Spinal Deformity, Scoliosis, Kyphosis, Sagittal Imbalance, Spinal Deformity