Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery

Status: Recruiting
Location: See all (19) locations...
Intervention Type: Procedure
Study Type: Observational
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
RECRUITING
La Jolla
University of California, Davis, Department of Orthopedic Surgery
ACTIVE_NOT_RECRUITING
Sacramento
UCSF, Department of Neurosurgery
RECRUITING
San Francisco
Colorado
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
RECRUITING
Denver
Kansas
University of Kansas, Department of Orthopedic Surgery
RECRUITING
Kansas City
Kentucky
Norton Leatherman Spine Center
RECRUITING
Louisville
Louisiana
Spine Institute of Louisiana
RECRUITING
Shreveport
Maryland
John Hopkins University, Department of Orthopedic Surgery
RECRUITING
Baltimore
Missouri
Washington University, Department of Orthopedic Surgery
RECRUITING
St Louis
North Carolina
Duke University Health System
RECRUITING
Durham
New York
Columbia University Medical Center
RECRUITING
New York
Hospital for Special Surgery, Department of Orthopedic Surgery
RECRUITING
New York
Northwell Health
RECRUITING
New York
NYU, Department of Orthopedics
RECRUITING
New York
Rhode Island
University Orthopedics
RECRUITING
Providence
Texas
Medical City Spine Hospital - Southwest Scoliosis Institute
RECRUITING
Dallas
University of Texas - Houston
RECRUITING
Houston
Virginia
University of Virginia
RECRUITING
Charlottesville
Other Locations
Canada
Toronto Western
RECRUITING
Toronto
Contact Information
Primary
Christine Baldus, MS
baldusc@wustl.edu
6184444130
Backup
Ray Pinteric
ray.pinteric@outlook.com
7209348014
Time Frame
Start Date: 2018-07-30
Estimated Completion Date: 2032-07-31
Participants
Target number of participants: 500
Treatments
Operative
A. Multicenter, prospective, nonrandomized analysis of operatively treated complex ASD patients meeting the following Inclusion Criteria~1. 18 years of age or greater at the time of treatment~2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity~3. Full body EOS radiographic assessment (sagittal and coronal visualization from skull to foot)~4. Complex patients are defined as and meeting any one of the subsequent criteria:~ a. Radiographic criteria: i. PI-LL ≥ 25 degrees ii. TPA ≥ 30 degrees iii. SVA\>15cm iv. Thoracic scoliosis ≥ 70 degrees v. Thoracolumbar/lumbar scoliosis ≥ 50 degrees vi. Global coronal malalignment \>7cm b. Procedural criteria: i. Posterior spinal fusion \> 12 levels ii. 3 column osteotomy or ACR c. Geriatric criteria: i. Age \>65 years and minimum 7 levels of spinal instrumentation during surgery
Related Therapeutic Areas
Sponsors
Collaborators: SI-BONE, Inc., Medtronic, Globus Medical Inc
Leads: International Spine Study Group Foundation

This content was sourced from clinicaltrials.gov