Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity
Launched by INTERNATIONAL SPINE STUDY GROUP FOUNDATION · May 28, 2021
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment option called the Symphony™ Posterior Cervical System for adults with cervical deformity, which is a condition that affects the curvature of the neck. The goal is to see how well this system works in helping to correct these deformities through surgery. The trial is currently looking for participants aged 18 and older who are planning to have surgery using this system within the next six months. Eligible participants may have specific types of cervical deformities, such as a noticeable curve in the neck or a misalignment of the spine.
If you or a loved one is interested in joining, you would need to complete some study forms and provide consent. Participants will be monitored before and after the surgery to gather important information about their recovery and the effectiveness of the treatment. However, individuals with certain conditions, like active spine tumors or infections, or those who are pregnant, cannot participate. This trial offers a chance to contribute to important research that could improve treatment options for neck deformities in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. ≥18 years old at time of treatment
- 2. Patient undergoing a posterior cervical instrumented fusion using the DePuy Synthes SymphonyTM OCT System for the treatment of adult cervical deformity, defined as any of below criteria:
- • 1. 10 degrees of overall cervical kyphosis (measured from C2-C7)
- • 2. 10 degrees of kyphosis across any 1 or 2 cervical segments
- • 3. 10 degrees of scoliosis
- • 4. C2-C7 SVA \>4cm
- • 3. Plan for surgical correction of cervical deformity in the next 6 months
- • 4. Willing to provide consent and complete study forms at baseline and follow-up intervals
- Exclusion Criteria:
- • 1. Active spine tumor or infection
- • 2. Deformity due to acute trauma
- • 3. Unwilling to provide consent or to complete study forms
- • 4. Prisoner
- • 5. 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
Kansas City, Kansas, United States
Baltimore, Maryland, United States
Ann Arbor, Michigan, United States
Charlottesville, Virginia, United States
Sacramento, California, United States
Durham, North Carolina, United States
Saint Louis, Missouri, United States
San Francisco, California, United States
New York, New York, United States
Ann Arbor, Michigan, United States
Pittsburgh, Pennsylvania, United States
Denver, Colorado, United States
La Jolla, California, United States
Patients applied
Trial Officials
Justin Smith, MD, PhD
Principal Investigator
University of Virginia
Christopher Shaffrey, MD
Principal Investigator
Duke University
Shay Bess, MD
Principal Investigator
Denver Int'l Spine Center, Rocky Mountain Hospital for Children & Presbyterian St. Luke's MC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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