Evaluation of a new surgical system for treating cervical deformities in adults
Prospective Evaluation of Symphony™ Posterior Cervical System for Surgical Treatment of Adult Cervical Deformity: A Multi-Center Study
This study is testing a new surgical system for fixing neck problems in adults to see how well it works and how it affects patients over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | International Spine Study Group Foundation Academic / other |
| Locations | 7 sites (Sacramento, California and 6 other locations) |
| Trial ID | NCT04912674 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the outcomes of the Symphony™ Posterior Cervical System in patients undergoing surgical treatment for adult cervical deformity. It will assess patient-reported outcomes, radiographic changes, and complication rates at multiple follow-up points over two years. The study also seeks to develop predictive models for surgical outcomes and examine the psychological impact of cervical deformity on patients. By analyzing these factors, the study aims to enhance surgical techniques and patient care in this field.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for posterior cervical fusion surgery using the Symphony™ system for cervical deformities.
Not a fit: Patients with active spine tumors, infections, or those whose deformities are due to acute trauma may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients with cervical deformities.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, but this specific evaluation of the Symphony™ system is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California and 6 other locations
- University of California Davis — Sacramento, California, United States (Active_not_recruiting)
- Denver International Spine Center, Rocky Mountain Hospital for Children and Presbyterian St. Luke's Medical Center — Denver, Colorado, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Withdrawn)
- Washington University — Saint Louis, Missouri, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Not_yet_recruiting)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Justin Smith, MD, PhD — University of Virginia
- Study coordinator: Jenny De Jong, MSN, RN
- Email: jenny_dejong@outlook.com
- Phone: 540-421-3101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.