Health Trials

About this trial

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, 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.

Eligibility criteria

Qualifiers

Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity

Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)

PI-LL ≥ 25 degrees

TPA ≥ 30 degrees

Disqualifiers

Age <18 years of age

Active spine tumor or infection

Deformity due to acute trauma

Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)

Trial design

Treatments tested in this trial

  • Index or spine revision surgery for complex adult spinal deformity

Treatment groups

1,500 Participants
are divided into 1 treatment group

Locations

18
Canada
Toronto Western TorontoOntario, Canada
United States
California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic92037, La Jolla United States
University of California, Davis, Department of Orthopedic Surgery05616, Sacramento United States
UCSF, Department of Neurosurgery94143, San Francisco United States

Sponsors and collaborators

International Spine Study Group Foundation

Lead sponsor

Medtronic

Collaborator

Globus Medical Inc

Collaborator

SI-BONE, Inc.

Collaborator

Source ClinicalTrials.gov