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

Description

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

Conditions

Cervical Deformity

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Cervical Deformity
Intervention / Treatment

-

Contacts and Locations

La Jolla

Shiley Center for Orthopaedic Research and Education at Scripps Clinic, La Jolla, California, United States, 92037

Sacramento

University of California Davis, Department of Orthopedic Surgery, Sacramento, California, United States, 95817

San Francisco

University of California-San Francisco Medical Center, San Francisco, California, United States, 94143

Denver

Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center, Denver, Colorado, United States, 80128

Chicago

Rush University, Department of Neurosurgery, Chicago, Illinois, United States, 60612

Kansas City

University of Kansas Medical Center, Department of Orthopedic Surgery, Kansas City, Kansas, United States, 66160

Louisville

Leatherman Spine Center, Department of Orthopedic Surgery, Louisville, Kentucky, United States, 40202

Baltimore

Johns Hopkins University, Department of Neurological Surgery, Baltimore, Maryland, United States, 21224

Ann Arbor

University of Michigan, Department of Neurosurgery, Ann Arbor, Michigan, United States, 48109

Saint Louis

Washington University, Department of Orthopedic Surgery, Saint Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

International Spine Study Group Foundation,

Justin Smith, MD, PRINCIPAL_INVESTIGATOR, University of Virginia, Department of Neurosurgery

Christopher Ames, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco, Department on Neurosurgery

Christopher I Shaffrey, MD, PRINCIPAL_INVESTIGATOR, Duke University, Departments of Neurosurgery and Orthopaedic Surgery

Study Record Dates

2033-07-31