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:

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

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

  3. Complex patients are defined as and meeting any one of the subsequent criteria:

    1. Radiographic criteria:

      • PI-LL ≥ 25 degrees
      • TPA ≥ 30 degrees
      • SVA>15cm
      • Thoracic scoliosis ≥ 70 degrees
      • Thoracolumbar/lumbar scoliosis ≥ 50 degrees
      • Global coronal malalignment >7cm
    2. Procedural criteria:

      • Posterior spinal fusion > 12 levels
      • 3 column osteotomy or ACR
    3. Geriatric criteria:

      • Age >65 years and minimum 7 levels of spinal instrumentation during surgery

Exclusion Criteria:

  1. Age <18 years of age
  2. Active spine tumor or infection
  3. Deformity due to acute trauma
  4. Neuromuscular conditions/diseases (Parkinson's, Multiple Sclerosis, Post-polio syndrome)
  5. Syndromic scoliosis
  6. Inflammatory arthritis/auto immune diseases (Rheumatoid arthritis, Lupus, Ankylosing Spondylitis)
  7. Prisoners
  8. Women who are pregnant
  9. 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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (18 locations)

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