Evaluating minimally invasive surgery for complex adult spinal deformities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Praveen Mummaneni, MD — University of San Francisco
• Study coordinator: Christine Baldus, MS
• Email: baldusc@wustl.edu
• Phone: 6184444130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.