Using SYMPHONY™ OCT System for treating upper spine instabilities
Clinical/Radiologic Outcomes Associated With the SYMPHONY™ OCT System for Treatment of Acute and Chronic Instabilities of the Craniocervical Junction, the Cervical Spine and the Upper Thoracic Spine
This study is testing if a new device called the SYMPHONY™ OCT System can improve surgery outcomes for patients with upper spine instabilities.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University College Dublin Academic / other |
| Locations | 1 site (Dublin, Leinster) |
| Trial ID | NCT06816862 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll patients undergoing posterior-only or combined anterior and posterior surgery for cervical spine instabilities, including traumatic fractures and failed previous fusions. The SYMPHONY™ OCT System, a CE-marked medical device, will be used to enhance spinal stabilization during these procedures. The study aims to evaluate the effectiveness of this system compared to historical cases treated with a different method. It will take place at a National Tertiary Referral Centre for spinal trauma, serving a large population.
Who should consider this trial
Good fit: Ideal candidates include patients with acute and chronic instabilities of the cervical and upper thoracic spine who are suitable for surgery.
Not a fit: Patients with severe medical comorbidities, established osteoporosis, or systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical outcomes and stabilization for patients with upper spine instabilities.
How similar studies have performed: While this approach utilizes a CE-marked device, the specific application of the SYMPHONY™ OCT System in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Consenting patients presenting for the treatment of acute and chronic instabilities of the craniocervical junction, the cervical and upper thoracic spine for whom the SYMPHONY OCT System is a suitable choice will be included in this study. * Patients undergoing surgical treatment for upper cervical spine traumatic spinal fractures and/or traumatic dislocations, failed previous fusions (pseudarthrosis) and tumours involving the cervical/thoracic spine will be included in this study. Exclusion Criteria: * Non-surgical candidates, patients with contraindications to surgery (e.g. severe medical comorbidities, known infection, etc.), * Patients with established osteoporosis * Long-term, systemic steroid use * Systemic diseases (e.g. rheumatoid arthritis, AIDS, HIV, etc.), * Patients unwilling or unable to give informed consent, or patients unwilling or unable to complete Health-related quality of (HRQOL) outcome life measures at the specified study time points pre- and post-operatively. * Subjects who have a history of drug or alcohol use that, in the opinion of the investigator would interfere with adherence to study requirements.
Where this trial is running
Dublin, Leinster
- Mater Misericordiae University Hospital — Dublin, Leinster, Ireland (Recruiting)
Study contacts
- Principal investigator: Joseph Butler, PhD — Mater Misericordiae University Hospital
- Study coordinator: Jake McDonnell, MRCS
- Email: jakemcdonnell@eril.ie
- Phone: 0852802958
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.