Status:
RECRUITING
Complex Adult Deformity Surgery (CADS)
Lead Sponsor:
International Spine Study Group Foundation
Collaborating Sponsors:
Medtronic
Globus Medical Inc
Conditions:
Adult Spinal Deformity
Scoliosis
Eligibility:
All Genders
18+ years
Brief Summary
Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical and postoperative c...
Detailed Description
Specific Aims: • Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients, including radiographic and clinical outcomes, surgical a...
Eligibility Criteria
Criteria:
Inclusion Criteria:
-
Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity
-
Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)
-
Complex patients are defined as and meeting any one of the subsequent criteria:
-
Radiographic criteria:
- PI-LL ≥ 25 degrees
- TPA ≥ 30 degrees
- SVA>15cm
- Thoracic scoliosis ≥ 70 degrees
- Thoracolumbar/lumbar scoliosis ≥ 50 degrees
- Global coronal malalignment >7cm
-
Procedural criteria:
- Posterior spinal fusion > 12 levels
- 3 column osteotomy or ACR
-
Geriatric criteria:
- Age >65 years and minimum 7 levels of spinal instrumentation during surgery
-
Exclusion Criteria:
- 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)
- Syndromic scoliosis
- Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
- Prisoners
- Women who are pregnant
- Non English speaking patients
Key Trial Info
Start Date :
July 30 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2032
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT04194138
Start Date
July 30 2018
End Date
July 31 2032
Last Update
February 17 2026
Active Locations (18)
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1
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, California, United States, 92037
2
University of California, Davis, Department of Orthopedic Surgery
Sacramento, California, United States, 05616
3
UCSF, Department of Neurosurgery
San Francisco, California, United States, 94143
4
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, Colorado, United States, 80218