RecruitingNCT04885244

Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery

Prospective Evaluation of Complex Adult Spinal Deformity (CAD) Treated With Minimally Invasive Surgery (MIS)


Sponsor

International Spine Study Group Foundation

Enrollment

500 participants

Start Date

Jul 28, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

Evaluate surgical treatment outcomes and identify best practice guidelines for complex adult spinal deformity (ASD) patients treated with minimally invasive approach, 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 study is collecting data on adult patients who have complex spinal deformity (abnormal curvature or alignment of the spine) and are undergoing minimally invasive spine surgery. The goal is to understand long-term outcomes of these advanced surgical techniques and help improve care for future patients. You may be eligible if: - You are over 18 years old - You have been diagnosed with an adult spinal deformity (congenital, degenerative, idiopathic, neuromuscular, inflammatory, or iatrogenic) - You meet at least one radiographic criterion (e.g., significant pelvic incidence-lumbar lordosis mismatch, scoliosis, or sagittal imbalance) OR one surgical criterion (e.g., 3+ levels of minimally invasive fusion) - Your surgery is scheduled within 6 months You may NOT be eligible if: - Your spinal deformity is due to acute trauma - You have an active spinal tumor or infection - You are unable or unwilling to fill out questionnaires - You are pregnant - You are a prisoner - Open (non-minimally invasive) posterior spinal fusion is planned 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(12)

Barrow Neurological Institute

Phoenix, Arizona, United States

Shiley Center for Orthopaedic Research and Education at Scripps Clinic

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of California - San Francisco Medical Center

San Francisco, California, United States

University of Miami

Miami, Florida, United States

Rush University, Department of Neurosurgery

Chicago, Illinois, United States

Louisiana Spine Institute

Shreveport, Louisiana, United States

University of Michigan, Department of Neurosurgery

Ann Arbor, Michigan, United States

Columbia University - New York-Presbyterian Och Spine Hospital

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Semmes-Murphey

Memphis, Tennessee, United States

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NCT04885244


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