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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
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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