RecruitingNCT04194138

Complex Adult Deformity Surgery (CADS)

Multi-Center Prospective Evaluation of Complex Adult Spinal Deformity Surgery


Sponsor

International Spine Study Group Foundation

Enrollment

1,500 participants

Start Date

Jul 30, 2018

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This registry study collects detailed clinical data on adults having complex spinal deformity surgery — procedures to correct severe curvature or malalignment of the spine that significantly affects posture and quality of life. These surgeries are among the most complex in orthopedics, often involving long fusion constructs and osteotomies (bone cuts). The registry aims to identify factors that predict outcomes and complications to improve surgical decision-making. Participants have a preoperative evaluation including full-body imaging and are followed up after surgery. There is no experimental intervention — it is a data collection study to better understand outcomes from complex spinal surgery. You may be eligible if... - You are 18 years or older - You have been diagnosed with adult spinal deformity (congenital, degenerative, idiopathic, or iatrogenic) - Your deformity meets specific radiographic or procedural criteria for complexity (e.g., large curves, multiple levels of fusion, or corrective bone cuts) - You have had a full-body EOS X-ray evaluation You may NOT be eligible if... - You are under 18 years of age - You have an active spinal tumor or infection - Your deformity is caused by acute trauma - You have a neuromuscular disease (e.g., Parkinson's, multiple sclerosis) - You are pregnant - You are a prisoner or non-English speaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREIndex or spine revision surgery for complex adult spinal deformity

Surgical interventions will be patient specified by treating surgeon.


Locations(18)

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, United States

University of California, Davis, Department of Orthopedic Surgery

Sacramento, California, United States

UCSF, Department of Neurosurgery

San Francisco, California, United States

Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center

Denver, Colorado, United States

University of Kansas, Department of Orthopedic Surgery

Kansas City, Kansas, United States

Norton Leatherman Spine Center

Louisville, Kentucky, United States

Spine Institute of Louisiana

Shreveport, Louisiana, United States

John Hopkins University, Department of Orthopedic Surgery

Baltimore, Maryland, United States

NYU, Department of Orthopedics

New York, New York, United States

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Northwell Health

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

University Orthopedics

Providence, Rhode Island, United States

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, United States

University of Texas - Houston

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Toronto Western

Toronto, Ontario, Canada

View Full Details on ClinicalTrials.gov

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NCT04194138


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