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Search / Trial NCT04194996

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

Launched by INTERNATIONAL SPINE STUDY GROUP FOUNDATION · Dec 10, 2019

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Cervical Deformity Kyphosis Scoliosis

ClinConnect Summary

The clinical trial titled "Radiographic and Clinical Evaluation of Surgical Treatment for Cervical Deformity" is looking at how well surgery can help adults with cervical deformities, which are conditions affecting the neck spine. This study involves multiple medical centers and will follow patients who are planning to have surgery within the next six months. Researchers want to see how effective the surgery is in improving patients' spine alignment and overall health.

To be eligible for this study, participants need to be at least 18 years old and have specific types of cervical deformities, such as significant curvature of the spine or abnormal angles between the vertebrae in the neck. However, people with active spine tumors, infections, or deformities caused by recent injuries cannot participate. Those who join will need to give their consent and complete some forms before and after their surgery to help researchers gather important information about their progress. This trial is currently recruiting participants, and everyone, regardless of gender, is welcome to apply.

Gender

ALL

Eligibility criteria

  • 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
  • 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
  • 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

About International Spine Study Group Foundation

The International Spine Study Group Foundation (ISSGF) is a leading organization dedicated to advancing research and clinical practices in spine surgery and care. Comprising a network of experts in the field, the foundation focuses on facilitating high-quality, multi-center clinical trials aimed at improving patient outcomes and enhancing the understanding of spinal disorders. Through collaboration with healthcare professionals, academic institutions, and industry partners, the ISSGF promotes evidence-based approaches to spine treatment, aiming to establish best practices and develop innovative solutions for complex spinal conditions.

Locations

New York, New York, United States

Durham, North Carolina, United States

Charlottesville, Virginia, United States

Pittsburgh, Pennsylvania, United States

La Jolla, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Saint Louis, Missouri, United States

New York, New York, United States

Dallas, Texas, United States

Sacramento, California, United States

Chicago, Illinois, United States

Kansas City, Kansas, United States

Louisville, Kentucky, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

New York, New York, United States

Patients applied

0 patients applied

Trial Officials

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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