RecruitingNot Applicable

SYMPHONY™ OCT System for Instabilities of the Upper Thoracic and Cervical Spine

Ireland35 participantsStarted 2024-12-01

Plain-language summary

This will be a prospective, multi-centre study at a National Tertiary Referral Centre for spinal trauma and spinal cord injuries, serving a catchment area of 5 million people. Consecutive patients undergoing posterior-only surgery or combined anterior and posterior surgery for degenerative cervical pathology, traumatic spinal fractures or dislocations, failed previous fusions or treatment for tumour involving the cervical/thoracic spine will be enrolled. This is a post-market trial, with a CE-marked medical device called the SYMPHONY OCT System which is currently in use in both centres. The SYMPHONY™ OCT System is a portfolio of internal fixation tools including screw, rods and hooks used as an adjunct to fusion for posterior stabilisation of the upper spine in skeletally mature patients. This pilot study hypothesizes that the use of SYMPHONY™ OCT System to treat upper spine instabilities will achieve results comparable to historical cases using the Mountaineer performed until 2021.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic Fusion at 24 months as inferred by Presence of Segmental Stability and Absence of Mechanical Failure on Xray/CT

Timeframe: 24 months

Trial details

NCT IDNCT06816862

SponsorUniversity College Dublin

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-30

Contact for this trial

Jake McDonnell, MRCS

0852802958 jakemcdonnell@eril.ie

View on ClinicalTrials.gov More Cervical Instabilities Spine trials