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Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity: A Multi-Center Study 2.0

Recruitingn/aAges 18 Years - anyAllInternational Spine Study Group Foundation
NCT04194996 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.

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📋 Eligibility rules (as published)
Inclusion Criteria: * ≥18 years old at time of treatment * Diagnosis of cervical deformity- must meet one or more of the following criteria: * C2-C7 sagittal kyphosis (Cobb \> 15 degrees) * T1S-CL \> 35o * Segmental cervical kyphosis \> 10 degrees between any 2 vertebra between C2-T1 or \> 15 degrees across any 3 vertebra between C2-T1 * Cervical scoliosis \> 10 degrees (Cobb angle must include end vertebra within the cervical spine) * C2-C7 SVA \> 4cm * McGregor's slope \> 20 degrees or CBVA \> 25 degrees OR * Planned Revision surgery for proximal junctional failure with an anticipated UIV in the cervical spine and an anticipated LIV in the thoracic or lumbar spine. * Plan for surgical correction of cervical deformity in the next 6 months * Willing to provide consent and complete study forms at baseline and follow-up intervals * Upright AP/Lateral entire spine (EOS or 36") * Upright AP/Lateral C spine ONLY IF C spine is not completely visible on entire spine films * Flex/Ext lateral C spine. Admin may allow exceptions w/ valid documentation. Exclusion Criteria: * Active spine tumor or infection * Deformity due to acute trauma * Unwilling to provide consent or to complete study forms * Prisoner * Pregnant or immediate plans to get pregnant
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What it tests

  • Surgical intervention
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Where

16 sites
Shiley Center for Orthopaedic Research and Education at Scripps Clinic
La Jolla, United States
University of California Davis, Department of Orthopedic Surgery
Sacramento, United States
University of California-San Francisco Medical Center
San Francisco, United States
Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center
Denver, United States
Rush University, Department of Neurosurgery
Chicago, United States
University of Kansas Medical Center, Department of Orthopedic Surgery
Kansas City, United States
Leatherman Spine Center, Department of Orthopedic Surgery
Louisville, United States
Johns Hopkins University, Department of Neurological Surgery
Baltimore, United States

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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