Using SYMPHONY™ OCT System for treating upper spine instabilities

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.