RecruitingNCT04194996

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

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

Sponsor

International Spine Study Group Foundation

Enrollment

200 participants

Start Date

Aug 1, 2019

Study Type

OBSERVATIONAL

Conditions

Cervical Deformity

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria14

≥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 Criteria5

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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Interventions

PROCEDURESurgical intervention

Surgical interventions will be patient specified by treating surgeon.

Locations(16)

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

University of California-San Francisco Medical Center

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

Rush University, Department of Neurosurgery

Chicago, Illinois, United States

University of Kansas Medical Center, Department of Orthopedic Surgery

Kansas City, Kansas, United States

Leatherman Spine Center, Department of Orthopedic Surgery

Louisville, Kentucky, United States

Johns Hopkins University, Department of Neurological Surgery

Baltimore, Maryland, United States

University of Michigan, Department of Neurosurgery

Ann Arbor, Michigan, United States

Hospital for Special Surgery, Department of Orthopedic Surgery

New York, New York, United States

New York University, Department of Orthopedic Surgery

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke University Health System

Durham, North Carolina, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Medical City Spine Hospital - Southwest Scoliosis Institute

Dallas, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04194996